186 results on '"Branko Kopjar"'
Search Results
2. 186 A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial of Efficacy and Safety of Riluzole in Acute Spinal Cord Injury Study (RISCIS)
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Michael G. Fehlings, Ali Moghaddamjou, James S. Harrop, Ralph Stanford, Jonathan Ball, Bizhan Aarabi, Brian Freeman, James D. Guest, Shekar N. Kurpad, James M. Schuster, Ahmad Nassr, Karl M. Schmitt, Jefferson R. Wilson, Darrel S. Brodke, Faiz U. Ahmad, Albert Yee, Zack Ray, Nathaniel P. Brooks, Jason Wilson, Branko Kopjar, and Paul M. Arnold
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Surgery ,Neurology (clinical) - Published
- 2023
3. Better Functional Recovery After Single-Level Compared With Two-Level Posterolateral Lumbar Fusion
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Scott D, Daffner, Joshua T, Bunch, Douglas C, Burton, R Alden, Milam Iv, Daniel K, Park, K Brandon, Strenge, Peter G, Whang, Howard S, An, and Branko, Kopjar
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General Engineering - Abstract
Background Multiple studies describe the outcomes of patients undergoing single-level and multilevel posterolateral lumbar fusion (PLF). However, a comparison of outcomes between single-level and two-level PLF is lacking. The aim of this prospective cohort study was to compare outcomes between single-level and two-level instrumented PLF. Methods A total of 42 patients were enrolled at nine US centers between October 2015 and June 2017. Data included radiologic outcomes, visual analog scale (VAS) Back and Leg Pain, disability per the Oswestry Disability Index (ODI), and health-related quality of life (QoL) per 36-Item Short Form Survey version 2.0 (SF-36v2) at six weeks and three, six, 12, and 24 months. Results Twelve-month and 24-month follow-ups were completed by 38 (90.5%) and 32 (76.2%) subjects, respectively. The average age was 67 years, and 54.8% were female. Twenty-six received single-level PLF, and 16 received two-level PLF. In the single-level group, there was one reoperation, two postoperative infections, and one dural tear. In the two-level group, there was one postoperative infection. The surgeon computed tomography (CT)-based evaluation of fusion rate was 67.6% (25/37) at 12-month follow-up and 94.1% (32/34) at 24-month follow-up. The third-party evaluation of fusion rate was 52.8% (19/36) at six months, 81.1% (30/37) at 12 months, and 86.5% (32/37) at 24 months. There was a tendency toward a higher fusion rate in single-level compared with two-level PLF. The ODI, SF-36v2 Mental Component Score (MCS), and VAS Back Pain and Leg Pain outcomes improved by the first follow-up visit in both the single-level and two-level groups. Improvement in the ODI was 5.86 (95% confidence interval (CI): 0.03-11.69) points greater in the single-level group compared with the two-level group. Conclusions Compared with the two-level PLF subjects, single-level PLF subjects had better functional outcomes and reported higher satisfaction with the outcome of surgery but showed similar fusion, pain, and generic health-related quality of life outcomes. Both single-level and two-level PLF subjects demonstrated high fusion rates in association with improvements in pain, functional, and quality of life outcomes, as well as high satisfaction levels.
- Published
- 2022
4. Polyethylene manufacturing characteristics have a major effect on the risk of revision surgery in cementless and hybrid total hip arthroplasties
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Joseph Pagkalos, Branko Kopjar, and Edward T Davis
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musculoskeletal diseases ,Acetabular liner ,medicine.medical_specialty ,Conventional polyethylene ,business.industry ,medicine.medical_treatment ,Total hip replacement ,Polyethylene ,Cementation (geology) ,Arthroplasty ,Surgery ,chemistry.chemical_compound ,chemistry ,medicine ,Prosthesis design ,Orthopedics and Sports Medicine ,business ,Total hip arthroplasty - Abstract
Aims The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). Methods Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad). Results A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best. Conclusion Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article: Bone Joint J 2020;102-B(1):90–101
- Published
- 2020
5. Using an asymmetric crosslinked polyethylene liner in primary total hip arthroplasty is associated with a lower risk of revision surgery : an analysis of the National Joint Registry
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Branko Kopjar, Joseph Pagkalos, and Edward T Davis
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Male ,Reoperation ,medicine.medical_specialty ,Arthroplasty, Replacement, Hip ,Total hip replacement ,Aseptic loosening ,Lower risk ,Prosthesis Design ,Posterior approach ,medicine ,Humans ,Orthopedics and Sports Medicine ,Registries ,Joint (geology) ,Aged ,Surgical approach ,business.industry ,Polyethylene liner ,Middle Aged ,Surgery ,Prosthesis Failure ,Polyethylene ,Female ,Hip Prosthesis ,business ,Total hip arthroplasty - Abstract
Aims The aim of our study was to investigate the effect of asymmetric crosslinked polyethylene liner use on the risk of revision of cementless and hybrid total hip arthroplasties (THAs). Methods We undertook a registry study combining the National Joint Registry dataset with polyethylene manufacturing characteristics as supplied by the manufacturers. The primary endpoint was revision for any reason. We performed further analyses on other reasons including instability, aseptic loosening, wear, and liner dissociation. The primary analytic approach was Cox proportional hazard regression. Results A total of 213,146 THAs were included in the analysis. Overall, 2,997 revisions were recorded, 1,569 in THAs with a flat liner and 1,428 in THAs using an asymmetric liner. Flat liner THAs had a higher risk of revision for any reason than asymmetric liner THAs when implanted through a Hardinge/anterolateral approach (hazard ratio (HR) 1.169, 95% confidence interval (CI) 1.022 to 1.337) and through a posterior approach (HR 1.122, 95% CI 1.108 to 1.346). There was no increased risk of revision for aseptic loosening when asymmetric liners were used for any surgical approach. A separate analysis of the three most frequently used crosslinked polyethylene liners was in agreement with this finding. When analyzing THAs with flat liners only, THAs implanted through a Hardinge/anterolateral approach were associated with a reduced risk of revision for instability compared to posterior approach THAs (HR 0.561 (95% CI 0.446 to 0.706)). When analyzing THAs with an asymmetric liner, there was no significant difference in the risk of revision for instability between the two approaches (HR 0.838 (95% CI 0.633 to 1.110)). Conclusion For THAs implanted through the posterior approach, the use of asymmetric liners reduces the risk of revision for instability and revision for any reason. In THAs implanted through a Hardinge/anterolateral approach, the use of an asymmetric liner was associated with a reduced risk of revision. The effect on revision for instability was less pronounced than in the posterior approach. Cite this article: Bone Joint J 2021;103-B(9):1479–1487.
- Published
- 2021
6. Is Preoperative Duration of Symptoms a Significant Predictor of Functional Outcomes in Patients Undergoing Surgery for the Treatment of Degenerative Cervical Myelopathy?
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Aria Nouri, Paul M. Arnold, Lindsay Tetreault, Pierre Côté, Jefferson R. Wilson, Mark R. N. Kotter, Michael G. Fehlings, and Branko Kopjar
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Adult ,medicine.medical_specialty ,Time Factors ,Functional impairment ,Preoperative care ,Neurosurgical Procedures ,Spinal Cord Diseases ,Cohort Studies ,Hypesthesia ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Quality of life ,Internal medicine ,medicine ,Humans ,In patient ,Prospective Studies ,Aged ,Aged, 80 and over ,Muscle Weakness ,Reflex, Abnormal ,business.industry ,Middle Aged ,medicine.disease ,Treatment Outcome ,Duration (music) ,030220 oncology & carcinogenesis ,Cohort ,Cervical Vertebrae ,Female ,Surgery ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Neck Disability Index - Abstract
Background Preoperative duration of symptoms may significantly impact outcomes in patients treated surgically for degenerative cervical myelopathy (DCM). Objective To (i) analyze whether duration of symptoms is associated with preoperative functional impairment, disability, and quality of life and (ii) determine the optimal timing for decompressive surgery. Methods Patients with DCM were prospectively enrolled in either the AOSpine North American or International study at 26 global sites (n = 757). Postoperative functional impairment was evaluated at 1-yr using the modified Japanese Orthopaedic Association (mJOA) score. Change scores between baseline and 1-yr were computed for the mJOA. Duration of symptoms was dichotomized into a "short" and "long" group at several cut-offs. Analysis of covariance was used to evaluate differences in change scores on the mJOA between duration of symptoms groups in 4-mo increments. Results Our cohort consisted of 424 men and 255 women, with a mean duration of symptoms of 26.1 ± 36.4 mo (0.25-252 mo). Duration of symptoms was not correlated with preoperative mJOA, Nurick, Neck Disability Index, or Short-Form (SF)-36 Physical and Mental Component Scores. Patients with a duration of symptoms shorter than 4 mo had significantly better functional outcomes on the mJOA than patients with a longer duration of symptoms (>4 mo). Thirty-two months was also a significant cut-off. Conclusion Patients who are operated on within 4 mo of symptom presentation have better mJOA outcomes than those treated after 4 mo. It is recommended that patients with DCM are diagnosed in a timely fashion and managed appropriately.
- Published
- 2018
7. Mid-term outcomes of the R3™ delta ceramic acetabular system in total hip arthroplasty
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Branko Kopjar, Peter Gebuhr, Matthew P. Revell, Edward T. Davis, Petri Virolainen, Ville Remes, and Bart Van Backlé
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Male ,Ceramics ,Time Factors ,Complications ,lcsh:Diseases of the musculoskeletal system ,Arthroplasty, Replacement, Hip ,Total hip arthroplasty (THA) ,Periprosthetic ,0302 clinical medicine ,lcsh:Orthopedic surgery ,UCLA Activity Rating Scale (UCLA ARS) ,Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) ,Orthopedics and Sports Medicine ,Prospective Studies ,030212 general & internal medicine ,Fixation (histology) ,030222 orthopedics ,Modified Harris hip score (mHHS) ,Femur Head ,Delta ceramic ,Middle Aged ,Prosthesis Failure ,Treatment Outcome ,medicine.anatomical_structure ,Bearing ,Female ,Hip Joint ,Joint Diseases ,Research Article ,Adult ,medicine.medical_specialty ,WOMAC ,Adolescent ,Outcomes ,Prosthesis Design ,Lower risk ,Hip replacement (animal) ,Young Adult ,03 medical and health sciences ,Femoral head ,medicine ,Humans ,Aged ,Subluxation ,business.industry ,Acetabulum ,medicine.disease ,Surgery ,lcsh:RD701-811 ,Ceramic-on-ceramic (CoC) ,Orthopedic surgery ,Hip Prosthesis ,lcsh:RC925-935 ,business ,R3™ delta Ceramic Acetabular System ,Follow-Up Studies - Abstract
Background Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3™ Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX® Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA). Methods Between June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative. Results Total WOMAC score improved from 63 (range, 22–91) preoperative to 8 (range, 0–8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris hip score improved from 45 (range, 10–87) preoperative to 83 (range, 25–100) at 3 months, 91 (range, 42–100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1–8) preoperative to 6.2 (range, 2–8) at 1 year; it marginally declined to 5.8 (range, 3–8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%. Conclusion Clinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative. Trial registration ClinicalTrials.Gov, NCT03566082, Registered 10 January 2018—retrospectively registered
- Published
- 2021
8. Long-term Outcomes of the R3™ Delta Ceramic Acetabular System in Total Hip Arthroplasty
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Edward Thomas Davis, Ville Remes, Petri Virolainen, Peter Gebuhr, Bart Van Backlé, Matthew P. Revell, and Branko Kopjar
- Abstract
Background: Whilst bony fixation of hip replacement has stable solutions, there remains controversy over which bearing best optimizes longevity and function. Ceramic-on-ceramic (CoC) bearing combinations are associated with lower risk of revision due to aseptic loosening and dislocation. Evidence for long-term functional outcomes of modern, 4th generation CoC bearings is limited. The aim of this study was to analyze outcomes and complications of the R3™ Acetabular System (Smith & Nephew, Inc., Cordova, TN, USA) in combination with BIOLOX® Delta ceramic femoral head in patients undergoing primary total hip arthroplasty (THA).Methods: Between June 2009 and May 2011, 175 patients (178 hips) were enrolled into a prospective, study at 6 sites in Europe and prospectively followed-up at 3 months and 1, 3, 5, and 7 years postoperative. Results: Total WOMAC score improved from 63 (range, 22-91) preoperative to 8 (range, 0- 8) at 1-year follow-up and remained unchanged at 7-year follow-up. Modified Harris Hip Score improved from 45 (range, 10-87) preoperative to 83 (range, 25-100) at 3 months, 91 (range, 42-100) at 1 year, and 92 (range, 46, 100) at 7 years. UCLA Activity Rating Scale score improved from 3.3 (range, 1-8) preoperative to 6.2 (range, 2-8) at 1 year; it marginally declined to 5.8 (range, 3-8) at 7-year follow-up. There were 4 trochanteric fractures and 5 patients died of unrelated reasons. Three hips were revised (2 periprosthetic fractures and 1 subluxation). The 7-year cumulative survival rate was 98.3%. Conclusion: Clinical and functional improvements of THA with CoC bearing are maintained at 7 years postoperative.
- Published
- 2020
9. Safety and efficacy of riluzole in patients undergoing decompressive surgery for degenerative cervical myelopathy (CSM-Protect): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial
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Praveen V. Mummaneni, Christopher I. Shaffrey, Branko Kopjar, Jetan H. Badhiwala, Darrel S. Brodke, Michael G. Fehlings, Henry Ahn, Kee D. Kim, K. Daniel Riew, Paul M. Arnold, W Bradley Jacobs, Alexander R. Vaccaro, Alan S. Hilibrand, Jason D Wilson, Michael J. Kelly, Daryl R. Fourney, Ahmad Nassr, S. Tim Yoon, H. Francis Farhadi, Eric M. Massicotte, James S. Harrop, and Carlo Santaguida
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Adult ,Male ,medicine.medical_specialty ,Decompressive Craniectomy ,Adolescent ,Endpoint Determination ,Population ,Intervertebral Disc Degeneration ,Placebo ,Neurosurgical Procedures ,law.invention ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,law ,medicine ,Clinical endpoint ,Humans ,030212 general & internal medicine ,education ,Adverse effect ,Aged ,Aged, 80 and over ,education.field_of_study ,Pain, Postoperative ,Riluzole ,business.industry ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Surgery ,Clinical trial ,Neuroprotective Agents ,Treatment Outcome ,Cervical Vertebrae ,Female ,Neurology (clinical) ,business ,Spinal Cord Compression ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Summary Background Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. Methods This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18–80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8–14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov , NCT01257828 . Findings From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference −0·38 points (−0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. Interpretation In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. Funding AOSpine North America.
- Published
- 2020
10. Polyethylene manufacturing characteristics have a major effect on the risk of revision surgery in cementless and hybrid total hip arthroplasties
- Author
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Edward T, Davis, Joseph, Pagkalos, and Branko, Kopjar
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Adult ,Male ,Reoperation ,Arthroplasty, Replacement, Hip ,Biomedical Technology ,Middle Aged ,Prosthesis Design ,Prosthesis Failure ,Polyethylene ,Risk Factors ,Humans ,Female ,Hip Prosthesis ,Prospective Studies ,Aged - Abstract
The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA).Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (0 Mrad to5 Mrad), G3 (≥ 5 Mrad to10 Mrad), and G4 (≥ 10 Mrad).A total of 5,329 THAs were revised, 1,290 of which were due to aseptic loosening. Total radiation dose, face asymmetry, and stabilization treatments were found to significantly affect implant survival. G1 had the highest revision risk for any reason and for aseptic loosening and G3 and G4 the lowest. Compared with G1, the adjusted hazard ratio for G2 was 0.74 (95% confidence interval (CI) 0.64 to 0.86), G3 was 0.36 (95% CI 0.30 to 0.43), and G4 was 0.38 (95% CI 0.31 to 0.47). The cumulative incidence of revision for aseptic loosening at 12 years was 0.52 and 0.54 per 100 THAs for G3 and G4, respectively, compared with 1.95 per 100 THAs in G1. Asymmetrical liners had a lower revision risk due to aseptic loosening and reasons other than aseptic loosening compared with symmetric (flat) liners. In G3 and G4, stabilization with vitamin E and heating above melting point performed best.Polyethylene liners with a total radiation dose of ≥ 5 Mrad, an asymmetrical liner face, and stabilization with heating above the melting point demonstrate best survival. Cite this article
- Published
- 2020
11. Second-generation bi-cruciate stabilized total knee system has a lower reoperation and revision rate than its predecessor
- Author
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Branko Kopjar and Bernhard Christen
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Adult ,Male ,Reoperation ,Risk ,medicine.medical_specialty ,Complications ,Knee Joint ,Total knee arthroplasty ,Kaplan-Meier Estimate ,Lower risk ,Total knee ,Bi-cruciate stabilized ,Cohort Studies ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Revision rate ,Longitudinal Studies ,Knee Arthroplasty ,Arthroplasty, Replacement, Knee ,Aged ,Retrospective Studies ,Aged, 80 and over ,030222 orthopedics ,business.industry ,Hazard ratio ,Revisions ,030229 sport sciences ,General Medicine ,Middle Aged ,Prosthesis Failure ,Surgery ,Orthopedic surgery ,Cohort ,Guided motion ,Female ,Reoperations ,Knee Prosthesis ,business ,Cohort study - Abstract
Introduction Total knee arthroplasty (TKA) can provide pain relief and good long-term results. However, nearly 30% of post-surgical patients are unsatisfied due to persistent pain and functional deficits. A second-generation bi-cruciate stabilized TKA device has a post-cam mechanism with an asymmetric femoral component, a polyethylene insert, and a medially concave and laterally convex shape. The device is designed to provide guided motion, and thus improve knee kinematics by more closely approximating a normal knee. The aim of this study was to evaluate early complication and revision rates of the second-generation device and to compare its clinical performance to the first-generation device. Materials and methods In this retrospective, longitudinal, non-concurrent cohort study, 140 TKAs were performed using the second-generation device on 131 patients from 2012 to 2016, and 155 TKAs were performed using the first-generation device on 138 patients from 2009 to 2012. Primary outcomes were occurrence of revisions and reoperations. Results There were 31 reoperations [3.21 per 100 observed component years (OCY)] in 22 (2.28 per 100 OCY) TKAs in the first-generation device cohort compared to five reoperations (1.92 per 100 OCY) in four TKAs (1.54 per 100 OCY) in the second-generation device cohort. The adjusted hazard ratio (HR) was 3.50 (P = 0.0254). There were 21 revisions (2.17 per 100 OCY) in 16 (1.66 per 100 OCY) TKAs in the first-generation device cohort, compared to only three revisions (1.15 per 100 OCY) in two TKAs (0.77 per 100 OCY) in the second-generation device cohort. The adjusted HR was 4.16 (P = 0.0693). Conclusion The improved design of the second-generation device appears to be associated with a lower risk of reoperation and revision compared to that of the first-generation device. Level of evidence III.
- Published
- 2018
12. Predictive factors of survival in a surgical series of metastatic epidural spinal cord compression and complete external validation of 8 multivariate models of survival in a prospective North American multicenter study
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Anick Nater, Lindsay A. Tetreault, Branko Kopjar, Paul M. Arnold, Mark B. Dekutoski, Joel A. Finkelstein, Charles G. Fisher, John C. France, Ziya L. Gokaslan, Laurence D. Rhines, Peter S. Rose, Arjun Sahgal, James M. Schuster, Alexander R. Vaccaro, and Michael G. Fehlings
- Subjects
Oncology ,Cancer Research ,medicine.medical_specialty ,Univariate analysis ,Proportional hazards model ,business.industry ,Hazard ratio ,Stepwise regression ,medicine.disease ,Primary tumor ,03 medical and health sciences ,0302 clinical medicine ,Spinal cord compression ,Internal medicine ,medicine ,030212 general & internal medicine ,Prospective cohort study ,business ,030217 neurology & neurosurgery ,Cohort study - Abstract
BACKGROUND This study was designed to identify preoperative predictors of survival in surgically treated patients with metastatic epidural spinal cord compression (MESCC), to examine how these predictors are related to 8 prognostic models, and to perform the first full external validation of these models in accordance with the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement. METHODS One hundred forty-two surgically treated patients with MESCC were enrolled in a prospective, multicenter North American cohort study and were followed for 12 months or until death. Cox regression was used. Noncollinear predictors with
- Published
- 2018
13. Geographic variations in clinical presentation and outcomes of decompressive surgery in patients with symptomatic degenerative cervical myelopathy: analysis of a prospective, international multicenter cohort study of 757 patients
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Tomoaki Toyone, Mehmet Zileli, Ziya L. Gokaslan, Ahmed M.S. Ibrahim, Darrel S. Brodke, Mark B. Dekutoski, Lindsay Tetreault, Rick C. Sasso, Massimo Scerrati, Shashank S. Kale, Osmar Santos de Moraes, Branko Kopjar, Alexander R. Vaccaro, Yasutsugu Yukawa, Christopher M. Bono, Masato Tanaka, Ciaran Bolger, Christopher I. Shaffrey, Paul M. Arnold, Michael Janssen, Eric J. Woodard, Giuseppe Barbagallo, S. Tim Yoon, Ronald H. M. A. Bartels, Michael G. Fehlings, Qiang Zhou, Gamaliel Tan, Helton Luiz Aparecido Defino, and Manuel Alvarado
- Subjects
Adult ,Male ,medicine.medical_specialty ,Pediatrics ,Decompression ,clinical presentation ,disease cau-sation ,Context (language use) ,Disease ,Spinal Cord Diseases ,Degenerative cervical myelopathy (DCM) is a progressive degen-erative spine disease and the most common cause of spinal cord impairment in adults worldwide.Few studies have reported on regional variations in demographics ,Degenerative cervical myelopathy (DCM) is a progressive degen-erative spine disease and the most common cause of spinal cord impairment in adults worldwide.Few studies have reported on regional variations in demographics, clinical presentation, disease cau-sation, and surgical effectiveness ,03 medical and health sciences ,Myelopathy ,Postoperative Complications ,All institutes and research themes of the Radboud University Medical Center ,0302 clinical medicine ,and surgical effectiveness ,medicine ,Humans ,Orthopedics and Sports Medicine ,In patient ,030212 general & internal medicine ,Prospective cohort study ,Aged ,business.industry ,DOENÇAS DA MEDULA ESPINHAL ,Length of Stay ,Middle Aged ,Decompression, Surgical ,medicine.disease ,Europe ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,North America ,Cervical Vertebrae ,Physical therapy ,Female ,Surgery ,Spondylosis ,Neurology (clinical) ,Presentation (obstetrics) ,business ,Intervertebral Disc Displacement ,030217 neurology & neurosurgery ,Cohort study - Abstract
Degenerative cervical myelopathy (DCM) is a progressive degenerative spine disease and the most common cause of spinal cord impairment in adults worldwide. Few studies have reported on regional variations in demographics, clinical presentation, disease causation, and surgical effectiveness.The objective of this study was to evaluate differences in demographics, causative pathology, management strategies, surgical outcomes, length of hospital stay, and complications across four geographic regions.This is a multicenter international prospective cohort study.This study includes a total of 757 symptomatic patients with DCM undergoing surgical decompression of the cervical spine.The outcome measures are the Neck Disability Index (NDI), the Short Form 36 version 2 (SF-36v2), the modified Japanese Orthopaedic Association (mJOA) scale, and the Nurick grade.The baseline characteristics, disease causation, surgical approaches, and outcomes at 12 and 24 months were compared among four regions: Europe, Asia Pacific, Latin America, and North America.Patients from Europe and North America were, on average, older than those from Latin America and Asia Pacific (p=.0055). Patients from Latin America had a significantly longer duration of symptoms than those from the other three regions (p.0001). The most frequent causes of myelopathy were spondylosis and disc herniation. Ossification of the posterior longitudinal ligament was most prevalent in Asia Pacific (35.33%) and in Europe (31.75%), and hypertrophy of the ligamentum flavum was most prevalent in Latin America (61.25%). Surgical approaches varied by region; the majority of cases in Europe (71.43%), Asia Pacific (60.67%), and North America (59.10%) were managed anteriorly, whereas the posterior approach was more common in Latin America (66.25%). At the 24-month follow-up, patients from North America and Asia Pacific exhibited greater improvements in mJOA and Nurick scores than those from Europe and Latin America. Patients from Asia Pacific and Latin America demonstrated the most improvement on the NDI and SF-36v2 PCS. The longest duration of hospital stay was in Asia Pacific (14.16 days), and the highest rate of complications (34.9%) was reported in Europe.Regional differences in demographics, causation, and surgical approaches are significant for patients with DCM. Despite these variations, surgical decompression for DCM appears effective in all regions. Observed differences in the extent of postoperative improvements among the regions should encourage the standardization of care across centers and the development of international guidelines for the management of DCM.
- Published
- 2018
14. P128. Six-year follow-up of i-FACTOR® peptide enhanced bone graft vs autograft in single level ACDF in a randomized single blinded FDA investigational device exemption study
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Paul M. Arnold, Alexander R. Vaccaro, Branko Kopjar, Michael G. Fehlings, and Rick C. Sasso
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Bone mineral ,medicine.medical_specialty ,business.industry ,Outcome measures ,Context (language use) ,Investigational device exemption ,Single level ,Biocompatible material ,Surgery ,Clinical trial ,Radiological weapon ,Medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business - Abstract
BACKGROUND CONTEXT i-FACTOR is a composite bone substitute material consisting of a P-15 synthetic collagen fragment adsorbed onto an organic bone mineral and suspended in an inert biocompatible hydrogel carrier. Previous analyses of the US FDA IDE study demonstrated the benefits of i-FACTOR compared to local autograft bone in single-level ACDF at 12- and 24-months postoperative. PURPOSE We report 6-year clinical and radiological outcomes of post-approval study. STUDY DESIGN/SETTING Subjects from a completed, prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled in a post-approval study and we report 6-year outcomes. PATIENT SAMPLE Of 319 subjects that participated in the IDE study, 220 were enrolled into post-approval 6 years follow-up autograft (n = 114) or i-FACTOR (n = 105) in a cortical ring allograft. OUTCOME MEASURES Radiological, clinical, and patient-reported outcomes. METHODS Subjects completed prospective, randomized, controlled, multicenter clinical trial that was conducted at 22 North American sites were enrolled into post-approval study 6 years follow-up. RESULTS Fusion rates at 72 months were 99.0% in i-FACTOR subjects and 98.2% in autograft subjects, with a difference of 0.8% (95% C.I., (95% CI -2.3%, 4.0%). Mean improvement in NDI in i-FACTOR subjects was 28.56 (95% CI 24.79, 32.33) compared to 29.17 (95% CI 25.46, 32.88) in autograft subjects, with a difference of -0.61 (2.793) (95% CI -6.10, 4.88). Neurologic success rate at 72 months was 95.89% in i-FACTOR subjects and 93.33% in autograft subjects, with a difference of 2.6% (95% CI, -4.70%, 9.81%). Overall success rate was 68% in i-Factor and 62% in autograft subjects. Safety outcomes were similar between the 2 treatment groups. Secondary surgery at any cervical level occurred in 20 (18.9%) i-FACTOR subjects and 23 (20.2%) autograft subjects (p=0.866). Pain and SF-36 outcomes were similar between the groups at all study visits. There were no adverse reactions associated with i-FACTOR. CONCLUSIONS At 6 years, i-FACTOR in ACDF resulted in similar outcomes compared to local autograft. Safety outcomes are acceptable and clinical and functional outcomes for i-FACTOR in the previous studies are confirmed. FDA DEVICE/DRUG STATUS I-Factor (Approved for this indication)
- Published
- 2021
15. i-Factor™ Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study
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Rick C. Sasso, Michael Janssen, Branko Kopjar, Robert F. Heary, Michael G. Fehlings, Paul M. Arnold, and Alexander R. Vaccaro
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Adult ,Male ,medicine.medical_specialty ,Visual analogue scale ,Anterior cervical discectomy and fusion ,Investigational device exemption ,Transplantation, Autologous ,law.invention ,Food and drug administration ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Randomized controlled trial ,law ,Humans ,Medicine ,Autografts ,Bone mineral ,030222 orthopedics ,Neck pain ,Bone Transplantation ,United States Food and Drug Administration ,business.industry ,Middle Aged ,United States ,Surgery ,Transplantation ,Spinal Fusion ,Treatment Outcome ,surgical procedures, operative ,Bone Substitutes ,Cervical Vertebrae ,Female ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Diskectomy ,Follow-Up Studies - Abstract
Background i-Factor™ Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the benefits of i-Factor™ compared to local autograft bone in single-level anterior cervical discectomy and fusion at 1-yr postoperative. Objective To report 2-yr follow-up. Methods Subjects randomly received either autograft (n = 154) or i-Factor™ (n = 165) in a cortical ring allograft and followed using radiological, clinical, and patient-reported outcomes. Results At 2 yr, the fusion rate was 97.30% and 94.44% in i-Factor™ and autograft subjects, respectively (P = .2513), and neurological success rate was 94.87% (i-Factor™) and 93.79% (autograft; P = .7869). Neck Disability Index improved 28.30 (i-Factor™) and 26.95 (autograft; P = .1448); Visual Analog Scale arm pain improved 5.43 (i-Factor™) and 4.97 (autograft) (p = .2763); Visual Analog Scale neck pain improved 4.78 (i-Factor™) and 4.41 (autograft; P = .1652), Short Form-36 (SF-36v2) Physical Component Score improved 10.23 (i-Factor™) and 10.18 (autograft; P = .4507), and SF36v2 Mental Component Score improved 7.88 (i-FactorTM) and 7.53 (autograft; P = .9872). The composite endpoint of overall success (fusion, Neck Disability Index improvement >15, neurological success, and absence of re-operations) was greater in i-Factor™ subjects compared to autograft subjects (69.83% and 56.35%, respectively, P = .0302). Twelve (7.45%) i-Factor™ subjects and 16 (10.53%) autograft subjects underwent re-operation (P = .3411). There were no allergic reactions associated with i-Factor™. Conclusion Use of i-Factor™ in anterior cervical discectomy and fusion is effective and safe, and results in similar outcomes compared to local autograft bone at 2 yr following surgery.
- Published
- 2017
16. Impact of Depression and Bipolar Disorders on Functional and Quality of Life Outcomes in Patients Undergoing Surgery for Degenerative Cervical Myelopathy
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Branko Kopjar, Paul M. Arnold, Anoushka Singh, Lindsay Tetreault, Hiroaki Nakashima, Michael G. Fehlings, and Narihito Nagoshi
- Subjects
medicine.medical_specialty ,business.industry ,MEDLINE ,Evidence-based medicine ,medicine.disease ,Surgery ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Quality of life ,Orthopedic surgery ,medicine ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Neurology (clinical) ,Bipolar disorder ,business ,Prospective cohort study ,030217 neurology & neurosurgery ,Depression (differential diagnoses) - Abstract
Study design Analysis of a combined prospective dataset. Objective To compare clinical outcomes in patients with and without preexisting depression or bipolar disorder undergoing surgery for degenerative cervical myelopathy (DCM). Summary of background data Psychiatric comorbidities, including depression, have been associated with worse clinical outcomes after lumbar spine surgery; however, it is unclear whether these psychiatric disorders are also predictive of outcomes in patients undergoing surgery for the treatment of DCM. Methods Four hundred and one patients with symptomatic DCM were enrolled in the prospective AOSpine International or North America study at twelve North American sites. Patients were evaluated preoperatively and at 6, 12, and 24 months using the modified Japanese Orthopedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short- Form 36v2 (SF-36v2) Health Survey. A mixed model analytic approach was used to evaluate differences in outcomes at 24 months among patients with and without psychiatric disorders, while controlling for relevant baseline characteristics and surgical factors. Results Ninety-seven patients (24.19%) were diagnosed with preexisting depression or bipolar disorder. There were more females (65.98%) with these psychiatric disorders than males (34.02%) (P Conclusion Patients with depression or bipolar disorder have smaller functional and quality of life improvements after surgery compared to patients without psychiatric comorbidities. Level of evidence 2.
- Published
- 2017
17. Surgery for degenerative cervical myelopathy: a patient-centered quality of life and health economic evaluation
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Christopher D. Witiw, Michael G. Fehlings, Eric M. Massicotte, Lindsay Tetreault, Fabrice Smieliauskas, and Branko Kopjar
- Subjects
Male ,Reoperation ,Canada ,medicine.medical_specialty ,Cost-Benefit Analysis ,Context (language use) ,Neurosurgical Procedures ,Spinal Cord Diseases ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Quality of life (healthcare) ,Patient-Centered Care ,Health care ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Prospective Studies ,030212 general & internal medicine ,Health economics ,business.industry ,Middle Aged ,medicine.disease ,Confidence interval ,Surgery ,Economic evaluation ,Cervical Vertebrae ,Quality of Life ,Physical therapy ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Cohort study - Abstract
Degenerative cervical myelopathy (DCM) represents the most common cause of non-traumatic spinal cord impairment in adults. Surgery has been shown to improve neurologic symptoms and functional status, but it is costly. As sustainability concerns in the field of health care rise, the value of care has come to the forefront of policy decision-making. Evidence for both health-related quality of life outcomes and financial expenditures is needed to inform resource allocation decisions.This study aimed to estimate the lifetime incremental cost-utility of surgical treatment for DCM.This is a prospective observational cohort study at a Canadian tertiary care facility.We recruited all patients undergoing surgery for DCM at a single center between 2005 and 2011 who were enrolled in either the AOSpine Cervical Spondylotic Myelopathy (CSM)-North America study or the AOSpine CSM-International study.Health utility was measured at baseline and at 6, 12, and 24 months following surgery using the Short Form-6D (SF-6D) health utility score. Resource expenditures were calculated on an individual level, from the hospital payer perspective over the 24-month follow-up period. All costs were obtained from a micro-cost database maintained by the institutional finance department and reported in Canadian dollars, inflated to January 2015 values.Quality-adjusted life year (QALY) gains for the study period were determined using an area under the curve calculation with a linear interpolation estimate. Lifetime incremental cost-to-utility ratios (ICUR) for surgery were estimated using a Markov state transition model. Structural uncertainty arising from lifetime extrapolation and the single-arm cohort design of the study were accounted for by constructing two models. The first included a highly conservative assumption that individuals undergoing nonoperative management would not experience any lifetime neurologic decline. This constraint was relaxed in the second model to permit more general parameters based on the established natural history. Deterministic and probabilistic sensitivity analyses were employed to account for parameter uncertainty. All QALY gains and costs were discounted at a base of 3% per annum. Statistical significance was set at the .05 level.The analysis included 171 patients; follow-up was 96.5%. Mean age was 58.2±12.0 years and baseline health utility was 0.56±0.14. Mean QALY gained over the 24-month study period was 0.139 (95% confidence interval: 0.109-0.170, p.001) and the mean 2-year cost of treatment was $19,217.82±12,404.23. Cost associated with the operation comprised 65.7% of the total. The remainder was apportioned over presurgical preparation and postsurgical recovery. Three patients required a reoperation over the 2-year follow-up period. The costs of revision surgery represented 1.85% of the total costs. Using the conservative model structure, the estimated lifetime ICUR of surgical intervention was $20,547.84/QALY gained, with 94.7% of estimates falling within the World Health Organization definition of "very cost-effective" ($54,000 CAD). Using the more general model structure, the estimated lifetime ICUR of surgical intervention was $11,496.02/QALY gained, with 97.9% of estimates meeting the criteria to be considered "very cost-effective."Surgery for DCM is associated with a significant quality of life improvement. The intervention is cost-effective and, from the perspective of the hospital payer, should be supported.
- Published
- 2017
18. Midterm Performance of a Guided-Motion Bicruciate-Stabilized Total Knee System: Results From the International Study of Over 2000 Consecutive Primary Total Knee Arthroplasties
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Bernhard Christen, Dante A. Marra, Harold E. Cates, Branko Kopjar, Adam I. Harris, Jan J. Malcorps, Bill K. Huang, Paul R. Sensiba, Christopher P. O’Grady, Hilde Vandenneucker, and John Hur
- Subjects
musculoskeletal diseases ,Adult ,Male ,Reoperation ,medicine.medical_specialty ,revision ,total knee arthroplasty ,Internationality ,Prosthesis-Related Infections ,Adolescent ,Knee Joint ,Kaplan-Meier ,bicruciate ,Kaplan-Meier Estimate ,Prosthesis Design ,Total knee ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,posterior stabilized ,medicine ,Humans ,Orthopedics and Sports Medicine ,Cumulative incidence ,Femur ,Registries ,Tibial insert ,Femoral component ,Arthroplasty, Replacement, Knee ,Aged ,Aged, 80 and over ,030222 orthopedics ,Tibia ,business.industry ,Patella ,Middle Aged ,musculoskeletal system ,United States ,Surgery ,Prosthesis Failure ,Europe ,Joint replacement registry ,Orthopedic surgery ,guided motion ,Registry data ,Female ,Implant ,business ,Knee Prosthesis - Abstract
BACKGROUND: The JOURNEY II Bi-Cruciate Stabilizing Total Knee System (BLINDED) is a second-generation guided-motion knee implant that has been used in over 100,000 primary total knee arthroplasties (TKAs) worldwide. However, performance information is limited. METHODS: Data for 2059 primary TKAs were abstracted at 7 US and 3 European sites. Estimates of cumulative incidence of revision were compared with registry data for cemented posterior-stabilized implants. RESULTS: Average age was 64.3 years (range, 18-91); 58.5% were females; and 12.3% TKAs were in subjects younger than 55 years. Patellae were resurfaced in 95.9%. Median time since primary TKA was 4.2 years; longest was 6.1 years; and 78.9% were 3 years or more since primary TKA. Of 67 revisions (3.2%), 20 (30%) involved femoral or tibial component removal compared to 42% in the Australian Joint Registry (Australian Orthopedic Association National Joint Replacement Registry). All-component revisions accounted for 15 of 67, femoral component only for 2 of 67, tibial component only for 3 of 67, patellar component with/without tibial insert exchange for 17 of 67, and isolated tibial insert exchange for 30 of 67. In addition, there were 18 reoperations without component exchange. Component revision indications were infection (33%), mechanical loosening (21%), fracture of bone around the joint (16%), and instability (15%). Kaplan-Meier revision estimate was 3.1 and 3.6 per 100 TKAs at 3 and 5 years, respectively, compared to Australian Orthopedic Association National Joint Replacement Registry estimates of 3.1 and 4.1 per 100 TKAs. CONCLUSION: The revision rate for the second-generation implant was similar to cemented posterior-stabilized registry controls. ispartof: JOURNAL OF ARTHROPLASTY vol:34 issue:7 pages:S201-S208 ispartof: location:United States status: published
- Published
- 2018
19. Clinical and Surgical Predictors of Complications Following Surgery for the Treatment of Cervical Spondylotic Myelopathy
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Michael G. Fehlings, Pierre Côté, Paul M. Arnold, Branko Kopjar, Natalia Nugaeva, Lindsay Tetreault, Giuseppe Barbagallo, and Gamaliel Tan
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,Surgery for cervical spondylotic myelopathy (CSM) is generally safe and effective. Nonetheless, complications occur in 11% to 38% of patients. Knowledge of important predictors of complications will help clinicians identify high-risk patients and institute prevention and management strategies ,Surgery for cervical spondylotic myelopathy (CSM) is generally safe and effective. Nonetheless ,03 medical and health sciences ,Postoperative Complications ,0302 clinical medicine ,Risk Factors ,Diabetes mellitus ,Humans ,Medicine ,Prospective Studies ,Adverse effect ,Prospective cohort study ,complications occur in 11% to 38% of patients. Knowledge of important predictors of complications will help clinicians identify high-risk patients and institute prevention and management strategies ,Aged ,Aged, 80 and over ,030222 orthopedics ,Univariate analysis ,business.industry ,Odds ratio ,Perioperative ,Middle Aged ,Decompression, Surgical ,medicine.disease ,Surgery ,Logistic Models ,Treatment Outcome ,medicine.anatomical_structure ,Multivariate Analysis ,Cervical Vertebrae ,Female ,Spondylosis ,Neurology (clinical) ,business ,Complication ,Spinal Cord Compression ,030217 neurology & neurosurgery ,Cervical vertebrae - Abstract
Background Surgery for cervical spondylotic myelopathy (CSM) is generally safe and effective. Nonetheless, complications occur in 11% to 38% of patients. Knowledge of important predictors of complications will help clinicians identify high-risk patients and institute prevention and management strategies. Objective To identify clinical and surgical predictors of perioperative complications in CSM patients. Methods Four hundred seventy-nine surgical CSM patients were enrolled in the prospective CSM-International study at 16 sites. A panel of physicians reviewed all adverse events and classified each as related or unrelated to surgery. Univariate analyses were performed to determine differences between patients who experienced a perioperative complication and those who did not. A complication prediction rule was developed using multiple logistic regression. Results Seventy-eight patients experienced 89 perioperative complications (16.25%). On univariate analysis, the major clinical risk factors were ossification of the posterior longitudinal ligament (OPLL) (P = .055), number of comorbidities (P = .002), comorbidity score (P = .006), diabetes mellitus (P = .001), and coexisting gastrointestinal (P = .039) and cardiovascular (P = .046) disorders. Patients undergoing a 2-stage surgery (P = .002) and those with a longer operative duration (P = .001) were at greater risk of perioperative complications. A final prediction model consisted of diabetes mellitus (odds ratio [OR] = 1.96, P = .060), number of comorbidities (OR = 1.20, P = .069), operative duration (OR = 1.07, P = .002), and OPLL (OR = 1.75, P = .040). Conclusion Surgical CSM patients have a higher risk of perioperative complications if they have a greater number of comorbidities, coexisting diabetes mellitus, OPLL, and a longer operative duration. Surgeons can use this information to discuss the risks and benefits of surgery with patients, to plan case-specific preventive strategies, and to ensure appropriate management in the perioperative period. Abbreviations BMI, body mass indexCSM, cervical spondylotic myelopathymJOA, modified Japanese Orthopaedic AssociationOPLL, ossification of the posterior longitudinal ligament.
- Published
- 2016
20. Efficacy of i-Factor Bone Graft versus Autograft in Anterior Cervical Discectomy and Fusion
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Paul M. Arnold, Ashvin I. Patel, Joseph D. Smucker, Alexander R. Vaccaro, Robert F. Heary, Michael G. Fehlings, Benoit Goulet, Rick C. Sasso, Michael Janssen, Branko Kopjar, and Iain H. Kalfas
- Subjects
Adult ,Male ,medicine.medical_specialty ,Anterior cervical discectomy and fusion ,Bone healing ,Investigational device exemption ,Transplantation, Autologous ,Degenerative disc disease ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Device Approval ,Humans ,Medicine ,Single-Blind Method ,Orthopedics and Sports Medicine ,Prospective Studies ,Radiculopathy ,Prospective cohort study ,030222 orthopedics ,Bone Transplantation ,United States Food and Drug Administration ,business.industry ,Middle Aged ,medicine.disease ,United States ,Surgery ,Transplantation ,Spinal Fusion ,Treatment Outcome ,Orthopedic surgery ,Cervical Vertebrae ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Diskectomy - Abstract
STUDY DESIGN A prospective, randomized, controlled, parallel, single-blinded noninferiority multicenter pivotal FDA IDE trial. OBJECTIVE The objective of this study was to investigate efficacy and safety of i-Factor Bone Graft (i-Factor) compared with local autograft in single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA i-Factor is a composite bone substitute material consisting of the P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral and suspended in an inert biocompatible hydrogel carrier. P-15 has demonstrated bone healing efficacy in dental, orthopedic, and nonhuman applications. METHODS Patients randomly received either autograft (N = 154) or i-Factor (N = 165) in a cortical ring allograft. Study success was defined as noninferiority in fusion, Neck Disability Index (NDI), and Neurological Success endpoints, and similar adverse events profile at 12 months. RESULTS At 12 months (follow-up rate 87%), both i-Factor and autograft subjects demonstrated a high fusion rate (88.97% and 85.82%, respectively, noninferiority P = 0.0004), significant improvements in NDI (28.75 and 27.40, respectively, noninferiority P
- Published
- 2016
21. Survival and Clinical Outcomes in Surgically Treated Patients With Metastatic Epidural Spinal Cord Compression: Results of the Prospective Multicenter AOSpine Study
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Michael G. Fehlings, Anick Nater, Lindsay Tetreault, Branko Kopjar, Paul Arnold, Mark Dekutoski, Joel Finkelstein, Charles Fisher, John France, Ziya Gokaslan, Eric Massicotte, Laurence Rhines, Peter Rose, Arjun Sahgal, James Schuster, and Alexander Vaccaro
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Cohort Studies ,03 medical and health sciences ,0302 clinical medicine ,Quality of life ,Spinal cord compression ,medicine ,Humans ,Brief Pain Inventory ,Survival rate ,Aged ,Aged, 80 and over ,Chemotherapy ,Spinal Neoplasms ,business.industry ,Middle Aged ,medicine.disease ,Surgery ,Oswestry Disability Index ,Survival Rate ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Female ,Observational study ,business ,Spinal Cord Compression ,030217 neurology & neurosurgery ,Cohort study - Abstract
Purpose Although surgery is used increasingly as a strategy to complement treatment with radiation and chemotherapy in patients with metastatic epidural spinal cord compression (MESCC), the impact of surgery on health-related quality of life (HRQoL) is not well established. We aimed to prospectively evaluate survival, neurologic, functional, and HRQoL outcomes in patients with MESCC who underwent surgical management. Patients and Methods One hundred forty-two patients with a single symptomatic MESCC lesion who were treated surgically were enrolled onto a prospective North American multicenter study and were observed at least up to 12 months. Clinical data, including Brief Pain Inventory, ASIA (American Spinal Injury Association) impairment scale, SF-36 Short Form Health Survey, Oswestry Disability Index, and EuroQol 5 dimensions (EQ-5D) scores, were obtained preoperatively, and at 6 weeks and 3, 6, 9, and 12 months postoperatively. Results Median survival time was 7.7 months. The 30-day and 12-month mortality rates were 9% and 62%, respectively. There was improvement at 6 months postoperatively for ambulatory status (McNemar test, P < .001), lower extremity and total motor scores (Wilcoxon signed rank test, P < .001), and at 6 weeks and 3, 6, and 12 months for Oswestry Disability Index, EQ-5D, and pain interference (paired t test, P < .013). Moreover, at 3 months after surgery, the ASIA impairment scale grade was improved (Stuart-Maxwell test P = .004). SF-36 scores improved postoperatively in six of eight scales. The incidence of wound complications was 10% and 2 patients required a second surgery (screw malposition and epidural hematoma). Conclusion Surgical intervention, as an adjunct to radiation and chemotherapy, provides immediate and sustained improvement in pain, neurologic, functional, and HRQoL outcomes, with acceptable risks in patients with a focal symptomatic MESCC lesion who have at least a 3 month survival prognosis.
- Published
- 2016
22. A Clinical Prediction Rule for Functional Outcomes in Patients Undergoing Surgery for Degenerative Cervical Myelopathy
- Author
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Branko Kopjar, Paul M. Arnold, Michael G. Fehlings, Pierre Côté, and Lindsay Tetreault
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Adult ,Male ,medicine.medical_specialty ,Multivariate analysis ,Clinical prediction rule ,Severity of Illness Index ,Spinal Cord Diseases ,Decision Support Techniques ,Laminoplasty ,Disability Evaluation ,Myelopathy ,Severity of illness ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Poisson Distribution ,Prospective Studies ,Prospective cohort study ,Aged ,Aged, 80 and over ,Univariate analysis ,business.industry ,Laminectomy ,Recovery of Function ,General Medicine ,Middle Aged ,Decompression, Surgical ,medicine.disease ,Confidence interval ,Surgery ,Logistic Models ,Spinal Fusion ,Treatment Outcome ,ROC Curve ,Relative risk ,Multivariate Analysis ,Cervical Vertebrae ,Female ,Spondylosis ,business ,Follow-Up Studies - Abstract
Background: Cervical spondylotic myelopathy (CSM) is a progressive spinal condition that is often managed surgically. Knowledge of important predictors of surgical outcome can provide decision support to surgeons and enable them to effectively manage their patients’ expectations. The purpose of this study was to identify the most important clinical predictors of surgical outcome in patients with CSM using data from two multinational prospective studies. Methods: A total of 757 patients treated surgically for CSM participated in either the CSM-North America or the CSM-International study. The model was designed to distinguish between patients who achieved a modified Japanese Orthopaedic Association (mJOA) score of ≥16 at the one-year follow-up and those who did not (mJOA < 16). A score of 16 was chosen as the cutoff as an mJOA of ≥16 translates to minimal impairment. Univariate analyses evaluated the relationship between outcome and various clinical predictors. Multivariate Poisson regression was used to create the final prediction rule and estimate relative risks. Results: Based on univariate analyses, the probability of achieving a score of ≥16 decreased with the presence of certain symptoms, including gait dysfunction, the presence of certain signs such as lower limb spasticity, positive smoking status, higher comorbidity score, more severe preoperative myelopathy, and older age. The final model consisted of six significant and clinically relevant predictors: baseline severity score (relative risk [RR], 1.11; 95% confidence interval [CI], 1.07 to 1.15), impaired gait (RR, 0.76 [ref. = absence]; 95% CI, 0.66 to 0.88), age (RR, 0.91 per decade; 95% CI, 0.85 to 0.96), comorbidity score (RR, 0.93; 95% CI, 0.88 to 0.98), smoking status (RR, 0.78 [ref. = non-smoking]; 95% CI, 0.65 to 0.93), and duration of symptoms (RR, 0.95; 95% CI, 0.90 to 0.99). Conclusions: Patients were more likely to achieve a score of ≥16 (indicating minimal impairment) if they were younger, had milder preoperative myelopathy, did not smoke, had fewer and less severe comorbidities, did not present with impaired gait, and had shorter symptom duration. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Published
- 2015
23. The Minimum Clinically Important Difference of the Modified Japanese Orthopaedic Association Scale in Patients with Degenerative Cervical Myelopathy
- Author
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Michael G. Fehlings, Pierre Côté, Aria Nouri, Branko Kopjar, and Lindsay Tetreault
- Subjects
Male ,medicine.medical_specialty ,education ,Cervical cord ,Severity of Illness Index ,Spinal Cord Diseases ,Myelopathy ,Severity of illness ,medicine ,Humans ,Orthopedics and Sports Medicine ,In patient ,Prospective Studies ,Prospective cohort study ,health care economics and organizations ,Aged ,business.industry ,Minimal clinically important difference ,Cervical Cord ,Middle Aged ,medicine.disease ,Cervical spine ,Surgery ,ROC Curve ,Multicenter study ,Physical therapy ,Female ,Functional status ,Neurology (clinical) ,business - Abstract
Analysis of the prospective AOSpine CSM-International and North America datasets and survey of AO Spine International.This study aims to define the minimum clinically important difference (MCID) of the modified Japanese Orthopaedic Association (mJOA) in patients with degenerative cervical myelopathy (DCM).The mJOA is the most frequently used clinician-administered tool to assess functional status in patients with DCM. By defining its MCID, clinicians can better evaluate treatment outcomes for this condition.Three methods were used to determine the MCID of the mJOA: (1) distribution-based, (2) anchor-based and receiver operating characteristic (ROC) analysis, and (3) professional opinion. Distribution-based methods were used to estimate the MCID by computing the half standard deviation and standard error of measurement. Using anchor-based methods, mJOA at 12 months after surgery was compared between patients who were "slightly improved" on the Neck Disability Index (NDI) and those who were "unchanged." ROC analysis was performed to compute a discrete integer value for the MCID that yielded the smallest difference between sensitivity and specificity. We repeated anchor-based methods for patients with mild (mJOA: 15-17), moderate (mJOA: 12-14), and severe disease (mJOA12).The half standard deviation of the baseline mJOA was 1.36 and the standard error of measurement was 1.21. The difference in mJOA between patients who "slightly improved" on the NDI and "unchanged" patients was 1.11. ROC analysis yielded a value of 2 for the MCID. The survey of 416 spine professionals confirmed these estimates: the mean response was 1.65 ± 0.66. The MCID significantly varied depending on myelopathy severity: ROC analysis yielded a threshold of 1 for mild, 2 for moderate, and 3 for severe patients.The MCID of the mJOA is estimated to be between 1 and 2 points and varies with myelopathy severity. This knowledge will enable clinicians to identify meaningful functional improvements in DCM patients.N/A.
- Published
- 2015
24. Errata
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Edward T, Davis, Joseph, Pagkalos, and Branko, Kopjar
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Orthopedics and Sports Medicine ,Surgery - Published
- 2020
25. Effect of Bearing Surface on Survival of Cementless and Hybrid Total Hip Arthroplasty
- Author
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Branko Kopjar, Joseph Pagkalos, and Edward T Davis
- Subjects
Proportional hazards model ,business.industry ,Hazard ratio ,Dentistry ,Northern ireland ,Confidence interval ,England wales ,Survivorship curve ,Bearing surface ,Medicine ,Orthopedics and Sports Medicine ,Surgery ,business ,Total hip arthroplasty - Abstract
Background Modern bearing surface options have increased implant survivorship after total hip arthroplasty (THA). We utilized data from the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR) to analyze implant survivorship after THAs with uncemented acetabular components with different bearing combinations. Methods Polyethylene (PE) manufacturing properties supplied by the manufacturers were used to subdivide the NJR data set into cross-linked PE (XLPE) and conventional PE groups. Overall and cause-specific revisions for various bearing combinations were analyzed using Kaplan-Meier and multivariate Cox proportional hazard regression survival analyses. Results Of 420,339 primary THAs, 8,025 were revised during an average follow-up period of 4.4 years (maximum, 13.3 years). In the Cox regression model with metal on conventional PE as the reference, the lowest risk of revision for any reason was for ceramicized metal on XLPE (hazard ratio [HR] = 0.58, 95% confidence interval [CI] = 0.48, 0.71), followed by ceramic on XLPE (HR = 0.66, 95% CI = 0.60, 0.72), ceramic on PE (HR = 0.74, 95% CI = 0.66, 0.82), ceramic on ceramic (HR = 0.77, 95% CI = 0.72, 0.82), and metal on XLPE (HR = 0.81, 95% CI = 0.76, 0.87). A similar pattern was observed when patients under the age of 55 years were analyzed independently. Younger age, male sex, and cementless stem fixation were associated with a higher risk of revision. Conclusions In a fully adjusted model, ceramicized metal on XLPE and ceramic on XLPE were associated with the lowest risk of revision for any reason. This finding was sustained when patients under the age of 55 years were analyzed independently. On the basis of the NJR data set, use of XLPE markedly reduces the risk of revision. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
- Published
- 2020
26. Outcomes of Surgical Decompression in Patients With Very Severe Degenerative Cervical Myelopathy
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Joshua H. Arnold, Branko Kopjar, Parker E. Bohm, Michael G. Fehlings, Paul M. Arnold, and Lindsay Tetreault
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Male ,medicine.medical_specialty ,Severity of Illness Index ,Spinal Cord Diseases ,Article ,Cohort Studies ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Postoperative Complications ,Internal medicine ,Severity of illness ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,030222 orthopedics ,business.industry ,Repeated measures design ,medicine.disease ,Decompression, Surgical ,Clinical trial ,Stenosis ,Treatment Outcome ,Cohort ,Cervical Vertebrae ,Female ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Cohort study ,Follow-Up Studies - Abstract
STUDY DESIGN A prospective observational international study. OBJECTIVE The aim of this study was to evaluate outcomes of decompressive surgery in patients with very severe degenerative cervical myelopathy (DCM). SUMMARY OF BACKGROUND DATA Although decompressive surgery has been evidenced as a safe and effective approach for patients with myelopathic deficiencies, studies have suggested residual disability following treatment in patients with more severe disease presentation. METHODS Postoperative outcomes of 60 patients with very severe DCM (modified Japanese Orthopaedic Association [mJOA] score ≤8) were compared to outcomes of 188 patients with severe DCM (mJOA 9-11). Postimputation follow-up rate was 93.1%. Unadjusted and adjusted analyses were performed using two-way repeated measures of covariance. RESULTS The two cohorts were similar in demographics, length of duration of myelopathy symptoms, source of stenosis, and surgical approaches used to decompress the spine. The very severe and severe cohorts differed in preoperative Nurick grades (4.97 vs. 3.91, respectively, P
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- 2018
27. 278. The impact of older age on functional recovery after surgical decompression for degenerative cervical myelopathy: results from an international, multicentre, prospective dataset in 757 patients
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Jamie R F Wilson, Michael G. Fehlings, Fan Jiang, Alexander R. Vaccaro, Jetan H. Badhiwala, Branko Kopjar, and Jefferson R. Wilson
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medicine.medical_specialty ,Univariate analysis ,business.industry ,Context (language use) ,medicine.disease ,Myelopathy ,Quality of life ,Internal medicine ,Diabetes mellitus ,Orthopedic surgery ,Cohort ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Observational study ,Neurology (clinical) ,business - Abstract
BACKGROUND CONTEXT Surgical decompression has been shown to improve long-term function, disability and quality of life (QOL) in degenerative cervical myelopathy (DCM); however, the role of surgery, and the effect on functional and QOL outcomes, in elderly patients with DCM is controversial. PURPOSE To investigate the effect of older age (over 70) on the functional and QOL impairment and outcomes after DCM surgery compared to younger adults. STUDY DESIGN/SETTING Prospective, multicentre observational studies on the outcomes of surgery for DCM; the AO Spine CSM-North America and the CSM-International studies. PATIENT SAMPLE A harmonized, combined dataset of 757 patients enrolled from both studies. OUTCOME MEASURES Functional assessment was performed with the modified Japanese Orthopedic Association score (mJOA). QOL outcomes were measured by the SF-36 physical and mental component scores. METHODS Of 757 patients enrolled in both studies, 107 patients were identified as elderly (70 years or older) at the time of surgery. Outcomes and functional status were assessed at 6-, 12- and 24-month intervals. In addition to unadjusted univariate analyses, multiple linear regression was used to evaluate the effect of age ≥70 on change in outcome scores adjusting for diabetes, cardiac comorbidities, cigarette smoking, psychiatric disorders, number of operated levels, surgical approach and baseline mJOA. RESULTS The baseline mJOA in the elderly group was significantly lower than the younger group (11.0 [95% CI 10.4-11.5] vs 12.9 [12.7-13.1]; p= CONCLUSIONS In this combined dataset from 2 large prospectively collected multicentre studies on DCM surgery, the group aged 70 or greater demonstrated significantly worse functional and QOL recovery when compared to the younger cohort after adjusting for the effect of comorbidities, number of operated levels, surgical approach and baseline mJOA. Elderly patients undergoing surgery for DCM should therefore be counseled appropriately regarding expectations of surgery. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.
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- 2019
28. Rationale, design and critical end points for the Riluzole in Acute Spinal Cord Injury Study (RISCIS): a randomized, double-blinded, placebo-controlled parallel multi-center trial
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Diana S.-L. Chow, Narihito Nagoshi, Robert G. Grossman, Branko Kopjar, Hiroaki Nakashima, and Michael G. Fehlings
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Adult ,Male ,0301 basic medicine ,medicine.medical_specialty ,Time Factors ,Neurology ,Adolescent ,Placebo ,Severity of Illness Index ,law.invention ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Severity of illness ,medicine ,Humans ,Spinal cord injury ,Spinal Cord Injuries ,Aged ,Riluzole ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Clinical trial ,Neuroprotective Agents ,Treatment Outcome ,030104 developmental biology ,Anesthesia ,Acute Disease ,Female ,Original Article ,Neurology (clinical) ,business ,Paraplegia ,030217 neurology & neurosurgery ,Follow-Up Studies ,medicine.drug - Abstract
Background: Riluzole is a sodium channel-blocking agent used in treating amyotrophic lateral sclerosis. It has been approved by the U.S. Food and Drug Administration, Canadian and Australian authorities, and in many other countries. A phase I trial of riluzole for acute spinal cord injury (SCI) provided safety and pharmacokinetic data and suggested neuroprotective benefits. A phase IIB/III double-blinded randomized controlled trial (RCT) started in January 2014 (https://clinicaltrials.gov, NCT01597518). This article describes the pathophysiological rationale, preclinical experience and design of the phase IIB/III RCT of Riluzole in Acute Spinal Cord Injury Study (RISCIS). Objectives: The primary objective of the trial is to evaluate the superiority of riluzole, at a dose of 100 mg BID in the first 24 h followed by 50 mg BID for the following 13 days post injury, compared with placebo in improving neurological motor outcomes in patients with C4–C8 level, International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) grade A, B or C acute (within 12 h post injury) SCI. Setting: Acute trauma centers worldwide Methods: A double-blind, multi-center, placebo-controlled RCT will enroll 351 participants randomized 1:1 to riluzole and placebo. The primary end point is the change between 180 days and baseline in ISNCSCI Motor Score. This study has 90% power to detect a change of nine points in ISNCSCI Motor Score at one-sided α=0.025. Results: Currently enrolling in 11 centers. Conclusion: This study will provide class I evidence regarding the safety and neuroprotective efficacy of riluzole in patients with acute cervical SCI.
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- 2015
29. Canadian Spine Society01.1.1: Surgery versus standardized nonoperative care for the treatment of lumbar disc herniations: a Canadian trial02.1.1: Wait times for elective spine surgery across Canada: data from the Canadian Spine Outcomes and Research Network03.1.1: Presurgical physician utilization in elective thoracolumbar spine surgery candidates: a nationwide analysis from the CSORN database04.1.2: Activities performed and treatments conducted prior to consultation with a spine surgeon: Are patients and clinicians following evidence-based clinical practice guidelines?05.1.2: Patient-reported disability versus objective physical performance measures in assessing patient recovery06.1.2: Risk factors for work status in low back pain patients: a cross-sectional analysis of patients presenting to the Ontario Inter-professional Spine Assessment and Education Clinics07.1.3: Comparison of symptomatic, functional and demographic characteristics of postsurgical versus nonoperative LBP patients08.1.3: Are primary care patients with different patterns of low back pain epidemiologically distinct?09.1.3: Lack of prognostic model validation in low back pain prediction studies10.1.4: Larger scoliosis curve magnitude is associated with increased surgical and perioperative complications: a multi-centre analysis of 1173 adolescent idiopathic scoliosis curves11.1.4: Superior extension of upper instrumented level in distraction-based surgery: a surrogate for clinically significant PJK12.1.4: The optimal surgical approach for Lenke 5 curves: Is the anterior approach ready for a comeback?13.1.5: Improving quality and safety in pediatric spine surgery: the team approach14.1.5: Posterior vertebral column resection in pediatric deformity: the advantages of staging15.1.5: Minimally invasive surgery in adolescent idiopathic scoliosis: lessons learned at mean 2-year follow-up16.2.1: Development of a Canadian competency-based spine surgery fellowship education curriculum17.2.1: Computer-assisted surgery is an effective educational tool for the training of orthopedic surgery residents in pedicle screw placement18.2.1: Validation of the Calgary Spine Severity Score19.2.2: Can triaging referrals with a simple 3-item pain questionnaire reduce wait times for consultations for patients who would benefit from lumbar spinal surgery?20.2.2: Strategies to improve the credibility of meta-analyses in spine surgery: a systematic survey21.2.2: The societal cost of waiting to see a spine surgeon for lower back symptoms in Canada22.2.3: The cost of an adverse event depends on its definition and method of capture23.2.3: Economic evaluation of intraoperative cone beam CT-based navigation for the placement of spinal pedicle screws: a patient-level cost-effectiveness analysis24.2.3: Predictors of inappropriate emergency department utilization following elective thoracolumbar spine surgery25.2.4: Incidence, impact and risk factors of adverse events in thoracic and lumbar spine fractures. An ambispective cohort analysis of 390 patients26.2.4: Factors associated with adverse events in major elective spine, knee, and hip in-patient orthopedic surgery27.2.4: Prognostic factors for survival in surgical series of symptomatic metastatic epidural spinal cord compression: a prospective North American multicentre study in 142 patients28.2.5: A comparison of 2 prospective adverse event recording tools with institutional ICD-10 coding for detecting perioperative adverse events in patients undergoing spinal surgery29.2.5: Assessment of impact of long-cassette standing radiographs on surgical planning for lumbar pathology: an international survey of spine surgeons30.2.5: Long-term patient-reported outcome and surgical survivorship of MIS fusion for low-grade spondylolisthesis31.3.1: The effect of prolonged postoperative antibiotic administration on the rate of infection in patients undergoing posterior spine surgery requiring a Hemovac drain32.3.1: Preliminary results of a Phase 1 trial on the use of photodynamic therapy in vertebral metastases33.3.1: The minimal clinically important difference of the modified Japanese Orthopaedic Association score in patients with degenerative cervical myelopathy undergoing surgical intervention34.3.1: Patient and surgeon radiation exposure during spinal instrumentation using intraoperative CT-based navigation35.3.2: Are postoperative pelvic parameters and sagittal balance predictive of further lumbar surgery in patients with spinal stenosis?36.3.2: Postoperative ambulation in patients undergoing total hip arthroplasty, total knee arthroplasty and elective lumbar spine surgery to treat arthritic pathologies37.3.2 Pain on the brain: Is the SF-36 mental component summary enough?38.3.2: Accurate and safe cervical osteotomy for kyphotic deformity in ankylosing spondylitis39.3.3: Adjacent segment pathology in the lumbar spine: progressive disease or a consequence of iatrogenic fusion?40.3.3: The association of cervical spine alignment with neurological recovery in a prospective cohort of surgical myelopathy patients: analysis of a series of 124 cases41.3.3: Use of neuropathic pain questionnaires in predicting the development of failed back surgery syndrome following lumbar discectomy for radiculopathy42.3.3: Quality of life and neurological outcomes after surgical decompression in patients with cervical ossification of the posterior longitudinal ligament: prospective, multicentre AOSpine International study of 479 patients43.3.4: Minimally invasive decompression in focal lumbar spinal stenosis with or without stable spondylolisthesis — comparative outcomes and reoperation rates at a minimum of 2 years44.3.4: Impact of nonoperative care utilization on postthoracolumbar spine surgery outcomes: a national perspective using the CSORN registry45.3.4: Presurgical imaging, testing and injection utilization in elective thoracolumbar spine surgery candidates: a nationwide analysis from the CSORN database46.3.5: A clinical prediction rule for clinical outcomes in patients undergoing surgery for degenerative cervical myelopathy: analysis of an international AOSpine prospective multi-centre dataset of 743 patients47.3.5: A comparison of health-related quality of life outcomes in spinal cord injury patients residing in rural and urban areas48.3.5: Minimally invasive versus open discectomy: a systematic review and meta-analysis49.1.1: Validity of transcranial motor evoked potentials as early indicators of neural compromise in rat model of spinal cord compression50.1.2: Validation of true spine length radiographic measurements51.1.3: Closure of the intervertebral disc annulus fibrosus using a novel suture application device — in vivo porcine and ex vivo biomechanical evaluation52.1.4: Vertebroplasty versus kyphoplasty in osteoporotic vertebral compression fracture model: What is safer?53.1.5: Brain-derived neurotrophic factor promotes intraneural macrophage migration and allodynia in experimental disc-herniation neuropathy54.1.6: Development and evaluation of an open-source 3D virtual simulator with integrated motion-tracking as a teaching tool for pedicle screw insertion55.2.7: Preoperative 'amber flag' psychological measure scores and patient expectations: a nationwide analysis from the CSORN database56.2.8: Assessment of frailty in elderly spinal surgery patients57.2.9: Predicting adverse events and their impact on hospital length of stay in a prospective Spine AdVerse Events Severity (SAVES) database58.2.10: Clinical and surgical predictors of perioperative complications in patients with degenerative cervical myelopathy: results from the multicentre, prospective AOSpine International study on 479 patients59.2.11: Longitudinal analysis of the incidence of adverse events in tertiary spine referral centres: a national perspective from the Canadian Spine Outcomes and Research Network (CSORN) registry60.2.12: The use of validated clinical outcome measures in spinal surgery: an analysis of recent annual meeting abstracts61.1.13: The efficacy and accuracy of cone beam CT (O-Arm) navigation (StealthStation) on screw position in primary cases of adult major deformity surgery62.1.14: Does early surgical decompression improve neurological recovery of complete spinal cord injury? A prospective cohort study63.1.15: The role of MRI in predicting surgical outcome in patients with degenerative cervical myelopathy64.1.16: Postsurgical patients can have similar functional improvements and return to work rates following rehabilitation as those treated nonsurgically65.1.17: Intraoperative cone beam CT (O-Arm) and stereotactic navigation (StealthStation) system in complex adult spine surgery — early experience and learning curve66.1.18: A pilot randomized controlled trial of iodine-impregnated plastic adhesive drape usage in spine surgery and the effect on wound bacterial load67.2.19: Dynesys long-term outcome study68.2.20: Maverick total disc replacement in a real-world patient population: a prospective, multicentre observational study69.2.21: Pedicle screw malposition in revision spinal surgery: efficacy of intraoperative CT-based navigation70.2.22: Intraoperative skull-femoral traction in posterior spinal arthrodesis for adolescent idiopathic scoliosis: the impact on perioperative outcomes and health resource utilization71.2.23: The effect of growth-friendly surgery on coronal and sagittal plane spine growth in idiopathic scoliosis72.2.24: A qualitative web-based expert opinion analysis on the adoption of intraoperative CT and navigation systems in spine surgery
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Melissa Nadeau, Chukwudi Chukwunyerenwa, David Parsons, Harvey Wu, Peter Jarzem, Godefroy Hardy-St-Pierre, Philippe Phan, Ana Contreras, Greg McIntosh, Aria Nouri, Etienne Bourassa-Moreau, John Street, Michael Johnson, Lindsay Tetreault, Tamir Ailon, Rachelle Palkovsky, Neil Manson, Stewart McLachlin, Mohammed Shamji, Fahad Abduljabbar, Antony Bateman, Alan Spurway, Susan Morris, Nathan Evaniew, R. Andrew Glennie, B. Roy Chaudhary, Hiroaki Nakashima, Andrew Jack, Jacques Bouchard, Erin Bigney, Michael Cochran, Joel Phillips, Albert Yee, Darryl Collings, Simon Harris, Dominic Maggio, Christopher Witiw, Anick Nater, Dov B. Millstone, Meghan Flood, Nicolas Dea, Clifford Lin, Ghazal Fazli, Darren Roffey, Ahmed Aoude, Jeremie Larouche, Firoz Miyanji, Nadim Joukhadar, Lauren DellaMora, Melissa McKeon, Elliot Layne, Alexandra Stratton, Chris Bailey, Stewart Bailey, Patricia Rosas-Arellano, Shauna Dehens, Keith Sequeira, Tom Miller, Jim Watson, Fawaz Siddiqi, Kevin Gurr, Jennifer Urquhart, Ken Thomas, Lauren Hirsch, Edward Abraham, Alana Green, Courtney Wilson, Stephen Kingwell, Eugene Wai, Emily Taylor, Joshua Murray, Wayne Albert, Raja Rampersaud, Hamilton Hall, Tom Carter, Chris Gregg, Anthony V. Perruccio, Elizabeth M. Badley, Y. Raja Rampersaud, Ivan Steenstra, Tracey Bastrom, Amer Samdani, Burt Yaszay, David Clements, Suken Shah, Michelle Marks, Randal Betz, Harry Shufflebarger, Peter Newton, David Skaggs, John Heflin, Mohamad Yasin, Ron El-Hawary, Jahangir Asghar, Christopher Reilly, John Choi, Janice Mok, Michael Nitikman, Sameer Desai, Siddesh Doddabasappa, Scott Paquette, Charles Fisher, Ian Domisse, Veronica Wadey, Joel Finkelstein, John Hurlbert, Robert Broad, Richard Fox, Doug Hedden, Andrew Nataraj, Tim Carey, Michael Chapman, Paul Moroz, Don Chow, Eva Tsai, Sean Christie, Kris Lundine, Jacques Paquet, Jan Splawinski, Brian Wheelock, Michael Goytan, Henry Ahn, Eric Massicotte, Michael Fehlings, Hamzah Alhamzah, Maryse Fortin, Jean Ouellet, Michael Weber, Ken C. Thomas, Matt Coyle, Leon van der Watt, Mohit Bhandari, Michelle Ghert, Ilyas Aleem, Brian Drew, Gordon Guyatt, Jeyagobi Jeyaratnam, Nadia Nandlall, Peter Coyte, Kala Sundararajan, Juliet Batke, Nic Dea, Branko Kopjar, Alexander Vaccaro, Paul Arnold, James Schuster, Laurence Rhines, Mark Dekutoski, Ziya Gokaslan, John France, Peter Rose, Justin Smith, Christopher Shaffrey, Virginie Lafage, Frank Schwab, Regis Haid, Themi Protopsaltis, Eric Klineberg, Justin Scheer, Shay Bess, Jens Chapman, Christopher Ames, Lori Nutt, Linda Kuska, Shane Burch, Arjun Sahgal, Edward Chow, Carolyn Niu, Carl Fisher, Cari Whyne, Margarete Akens, Stuart Bisland, Brian Wilson, Pierre Cote, Daniel Mendelsohn, Jason Strelzow, Marcel Dvorak, Corinne Tallon, Neil A. Manson, Alana J. Green, Edward P. Abraham, Ken Mogadham, Ganesh Swamy, Antonio Tsahtsarlis, Mashfiqul Siddiqui, Godefroy Hardy-St. Pierre, Chandan Mohanty, Alina Shcharinsky, Narihito Nagoshi, Nouri Aria, Rohit Amritanand, Steven Passmore, Vanessa Noonan, Moin Khan, Desmond Kwok, Jason Howard, Douglas Rasmusson, Waleed Kishta, Christian Balkovec, Robert Harrison, Stuart McGill, Abdulaziz Al-Jurayyan, Saad Alqahtani, Zeeshan Sardar, Rajeet Singh Saluja, Thomas Steffen, Lorne Beckman, YuShan Tu, Michael Salter, Brendan Polley, Mirza Beig, Fred Nicholls, Peter Wagner, Hanbing Zhou, Natalie Egge, Maribeth Harrigan, Anthony Lapinsky, Patrick Connoly, Christian DiPaola, Gamaliel Tan, Isaac Ryan Perlus, Jim Kennedy, Brian Lenehan, Danny Mendelsohn, Jean-Marc Mac-Thiong, Stefan Parent, Ang Li, Cynthia Thompson, Juan Zamorano, Kristian Dalzell, Aileen Davis, David Mikulis, Marcel F.S. Dvorak, Charles G. Fisher, Vu (Brian) Le, Paul MacPherson, Marc Desjardins, Ronald L. Henderson, Leonardo Simoes, Richard Assaker, Karsten Ritter-Lang, Dominique Vardon, Stephane Litrico, Stephane Fuentes, Michael Putzier, Jorg Frank, Pierre Guigui, Gerard Nakach, Jean-Charles Le Huec, Andrew Pennington, Kaiyun Yang, Rachael Da Cunha, Samir Al Sayegh, Jeremy LaMothe, Michael Letal, Herman Johal, Fabio Ferri-de-Barros, Luke Gauthier, Charlie Johnston, Anna McClung, Helen Novak Lauscher, and Charles Fischer
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Surgery - Published
- 2015
30. Short-term safety and effectiveness of a second-generation motion-guided total knee system
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Jason E. Lang, Branko Kopjar, Adam I. Harris, and Tianyi David Luo
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musculoskeletal diseases ,medicine.medical_specialty ,Radiography ,Total knee ,03 medical and health sciences ,0302 clinical medicine ,Patient satisfaction ,lcsh:Orthopedic surgery ,Pain level ,medicine ,Orthopedics and Sports Medicine ,Cumulative incidence ,030212 general & internal medicine ,Original Research ,030222 orthopedics ,business.industry ,TKA ,medicine.disease ,musculoskeletal system ,Confidence interval ,lcsh:RD701-811 ,Total knee arthroplasty ,Iliotibial band syndrome ,Cohort ,Physical therapy ,Guided motion ,Surgery ,business ,human activities - Abstract
Background Modern knee prostheses are designed to more closely replicate normal knee kinematics. The JOURNEY II Bi-Cruciate Stabilized Total Knee System (Smith & Nephew Inc., Memphis, TN) is a second-generation motion-guided knee system that demonstrates axial rotation patterns during flexion, which resemble those of the normal knee. The aim of this study was to assess the short-term safety and effectiveness of this system in standard clinical practice. Methods A total of 186 subjects (209 primary total knee arthroplasties [TKAs]) were enrolled at 12 U.S. sites. Subjects were operated on between December 2011 and October 2013 and followed for 24 months. Radiographic, clinical, and patient-reported outcome data were collected at 6-, 12-, and 24-month postoperatively. Results At 24-month follow-up, the average objective Knee Society Score was 96.20 (standard deviation [SD] = 6.63), the average satisfaction score was 35.22 (SD = 6.63), the average expectation score was 10.91 (SD = 3.16), and the average functional activities score was 81.49 (SD = 14.65). On a 0-10 scale, pain level for walking was 0.79 (SD = 1.51) and 1.50 (SD = 1.97) for climbing stairs or inclines. The cumulative incidence of reoperation at 2-year follow-up was 1.48% (95% confidence interval [CI] 0.48%-4.52%). Ten TKAs in 7 patients were treated with closed manipulations for stiffness. Iliotibial band syndrome was reported in 2 TKAs. Two deep infections occurred, 1 requiring reoperation. No dislocations occurred in the study cohort. Conclusions In short-term follow-up, the JOURNEY II Bi-Cruciate Stabilized Guided Motion Total Knee System appears to be a safe and effective device for TKA.
- Published
- 2017
31. Predictive factors of survival in a surgical series of metastatic epidural spinal cord compression and complete external validation of 8 multivariate models of survival in a prospective North American multicenter study
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Anick, Nater, Lindsay A, Tetreault, Branko, Kopjar, Paul M, Arnold, Mark B, Dekutoski, Joel A, Finkelstein, Charles G, Fisher, John C, France, Ziya L, Gokaslan, Laurence D, Rhines, Peter S, Rose, Arjun, Sahgal, James M, Schuster, Alexander R, Vaccaro, and Michael G, Fehlings
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Adult ,Aged, 80 and over ,Male ,Models, Statistical ,Spinal Neoplasms ,Adolescent ,Middle Aged ,Decompression, Surgical ,Prognosis ,Survival Analysis ,Cohort Studies ,Young Adult ,Treatment Outcome ,Predictive Value of Tests ,Multivariate Analysis ,North America ,Humans ,Female ,Epidural Neoplasms ,Spinal Cord Compression ,Aged - Abstract
This study was designed to identify preoperative predictors of survival in surgically treated patients with metastatic epidural spinal cord compression (MESCC), to examine how these predictors are related to 8 prognostic models, and to perform the first full external validation of these models in accordance with the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement.One hundred forty-two surgically treated patients with MESCC were enrolled in a prospective, multicenter North American cohort study and were followed for 12 months or until death. Cox regression was used. Noncollinear predictors with 10% missing data, with ≥ 10 events per stratum, and with P .05 in a univariate analysis were tested through a backward stepwise selection. For the original and revised Tokuhashi prognostic scoring systems (PSSs), Tomita PSS, modified Bauer PSS, van der Linden PSS, Bartels model, Oswestry Spinal Risk Index, and Bollen PSS, this study examined calibration graphically, discrimination with Harrell c-statistics, and survival stratified by risk groups with the Kaplan-Meier method and log-rank test.The following were significant in the univariate analysis: type of primary tumor, sex, organ metastasis, body mass index, preoperative radiotherapy to MESCC, physical component (PC) of the 36-Item Short Form Health Survey, version 2 (SF-36v2), and EuroQol 5-Dimension (EQ-5D) Questionnaire. Breast, prostate and thyroid primary tumor (HR: 2.9; P =.0005), presence of organ metastasis (hazard ratio (HR): 2.0; P = .005) and SF-36v2 PC (HR: 0.95; P.0001) were associated with survival in multivariable analysis. Predicted prognoses poorly matched observed values on calibration plots; Bartels model calibration slope was 0.45. Bollen PSS (0.61; 95% CI: 0.58-0.64) and Bartels model (0.68; 95% CI: 0.65-0.71) had the lowest and highest c-statistics, respectively.The primary tumor type (breast, prostate, or thyroid), an absence of organ metastasis, and a lower degree of physical disability are preoperative predictors of longer survival for surgical MESCC patients. These results are in keeping with current models. This full external validation of 8 prognostic PSSs or model of survival in surgical MESCC patients has revealed that calibration is poor, especially for long-term survivors, whereas discrimination is possibly helpful.
- Published
- 2017
32. Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies
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Michael G. Fehlings, Paul M. Arnold, Giuseppe Barbagallo, Narihito Nagoshi, Lindsay Tetreault, Hiroaki Nakashima, and Branko Kopjar
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Adult ,Male ,medicine.medical_specialty ,Decompression ,medicine.medical_treatment ,Comorbidity ,03 medical and health sciences ,Myelopathy ,Disability Evaluation ,0302 clinical medicine ,Quality of life ,Risk Factors ,Internal medicine ,otorhinolaryngologic diseases ,medicine ,Prevalence ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,Aged ,Aged, 80 and over ,030222 orthopedics ,business.industry ,Age Factors ,General Medicine ,Perioperative ,Middle Aged ,medicine.disease ,Decompression, Surgical ,Dysphagia ,Surgery ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,Cervical Vertebrae ,Quality of Life ,Female ,Spondylosis ,medicine.symptom ,business ,Deglutition Disorders ,030217 neurology & neurosurgery - Abstract
Background Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion. Methods Four hundred and seventy patients undergoing a 1-stage anterior or 2-stage anteroposterior cervical decompression and fusion were enrolled in the prospective AOSpine CSM (Cervical Spondylotic Myelopathy) North America or International study at 26 global sites. Logistic regression analyses were conducted to determine important clinical and surgical predictors of perioperative dysphagia. Preoperatively and at each follow-up visit, patients were evaluated using the modified Japanese Orthopaedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short Form-36 Health Survey (SF-36). A 2-way repeated-measures analysis of covariance was used to evaluate differences in outcomes at 6 and 24 months between patients with and those without dysphagia, while controlling for relevant baseline characteristics and surgical factors. Results The overall prevalence of dysphagia was 6.2%. Bivariate analysis showed the major risk factors for perioperative dysphagia to be a higher comorbidity score, older age, a cardiovascular or endocrine disorder, a lower SF-36 Physical Component Summary score, 2-stage surgery, and a greater number of decompressed levels. Multivariable analysis showed patients to be at an increased risk of perioperative dysphagia if they had an endocrine disorder, a greater number of decompressed segments, or 2-stage surgery. Both short and long-term improvements in functional, disability, and quality-of-life scores were comparable between patients with and those without dysphagia. Conclusions The most important predictors of dysphagia are an endocrine disorder, a greater number of decompressed levels, and 2-stage surgery. At the time of both short and long-term follow-up, patients with perioperative dysphagia exhibited improvements in functional, disability, and quality-of life scores that were similar to those of patients without dysphagia. Level of evidence Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
- Published
- 2017
33. A Novel Axial-Stress Bioreactor System Combined with a Substance Exchanger for Tissue Engineering of 3D Constructs
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Branko Kopjar, Song Tao Li, Shi Wu Dong, Lei Song, Ren Fa Lue, Ping Guo, Qiang Zhou, and Yong Liu
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Proliferation index ,Partial Pressure ,Cellular differentiation ,Biomedical Engineering ,Bone Matrix ,Medicine (miscellaneous) ,Bone Marrow Cells ,Cell Count ,Bioengineering ,Matrix (biology) ,Mice ,chemistry.chemical_compound ,Tissue culture ,Bioreactors ,Tissue engineering ,Osteogenesis ,Bioreactor ,Animals ,Cell Proliferation ,Tissue Engineering ,Tissue Scaffolds ,Chemistry ,Cell Cycle ,Mesenchymal stem cell ,Reproducibility of Results ,Cell Differentiation ,Mesenchymal Stem Cells ,Hydrogen-Ion Concentration ,Alkaline Phosphatase ,Lactic acid ,Mice, Inbred C57BL ,Oxygen ,Biophysics ,Cattle ,Stress, Mechanical ,Biomedical engineering - Abstract
This study introduced a prototype of an axial-stress bioreactor system that supports long-term growth and development of engineered tissues. The main features of this bioreactor are an integrated substance exchanger and feedback control of pH and PO₂. A 21-day study was conducted to validate the system's ability to maintain a stable environment, while remaining sterile. Our results showed that the pH, PO₂, and nutrient (glucose) remained balanced at appropriate levels, while metabolic waste (lactic acid) was removed. No bacteria or fungi were detected in the system or tissue; thus, demonstrating that it was sterile. These data indicate the bioreactor's strong potential for long-term tissue culture. To explore this idea, the effect of dynamic culture, including cyclic compression and automatic substance exchange, on mouse bone-marrow mesenchymal stem cells (BMSCs) seeded in decalcified bone matrix was studied using the bioreactor prototype. Histological sections of the engineered tissues showed higher cell densities in scaffolds in dynamic culture compared to those in static culture, while cell cycle analysis showed that dynamic culture promoted BMSC proliferation (proliferation index, PI=34.02±1.77) more effectively than static culture (PI=26.66±1.81). The results from a methyl thiazolyl tetrazolium assay were consistent with the loading experimental data. Furthermore, elevated alkaline phosphatase activity and calcium content were observed in dynamic condition compared to static culture. In conclusion, this bioreactor system supplies a method of modulating the pH and PO₂ in defined ranges with only small fluctuations; it can be used as a physiological or pathological analog. Automatic control of the environment is a practical solution for long-term, steady-state culture for future commercialization.
- Published
- 2014
34. Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM)
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Jens R Chapman, Paul M. Arnold, Christopher I. Shaffrey, Michael Janssen, Michael G. Fehlings, Alexander R. Vaccaro, Ziya L. Gokaslan, Robert Banco, Eric J. Woodard, Darrel S. Brodke, Mark B. Dekutoski, Justin S. Smith, Rick C. Sasso, Branko Kopjar, Christopher M. Bono, Sangwook Tim Yoon, and Eric M. Massicotte
- Subjects
Adult ,Male ,medicine.medical_specialty ,Context (language use) ,Disability Evaluation ,Quality of life ,Spinal cord compression ,Diabetes mellitus ,Internal medicine ,Diabetes Mellitus ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,Contraindication ,Aged ,business.industry ,Contraindications ,Middle Aged ,Decompression, Surgical ,Prognosis ,medicine.disease ,Surgery ,Treatment Outcome ,Orthopedic surgery ,Cervical Vertebrae ,Female ,Spondylosis ,Neurology (clinical) ,business ,Spinal Cord Compression ,Cohort study - Abstract
Background context Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process, including extent of spinal cord compression, duration of symptoms, and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems, including the central and peripheral nervous systems. There has been little information regarding the effect of diabetes on patients with coexistent CSM. Purpose To provide empirical data regarding the effect of diabetes on treatment outcomes in patients who underwent surgical decompression for coexistent CSM. Study design/setting Large prospective multicenter cohort study of patients with and without diabetes who underwent decompressive surgery for CSM. Patient sample Two hundred thirty-six patients without and 42 patients with diabetes were enrolled. Of these, 37 were mild cases and five were moderate cases. Four required insulin. There were no severe cases associated with end-organ damage. Outcome measures Self-report measures include Neck Disability Index and version 2 of 36-Item Short Form Health Survey (SF-36v2), and functional measures include modified Japanese Orthopedic Association (mJOA) score and Nurick grade. Methods We compared presurgery symptoms and treatment outcomes between patients with and without diabetes using univariate and multivariate models, adjusting for demographics and comorbidities. Results Diabetic patients were older, less likely to smoke, and more likely to be on social security disability insurance. Patients with diabetes presented with a worse Nurick grade, but there were no differences in mJOA and SF-36v2 at presentation. Overall, there was a significant improvement in all outcome parameters at 12 and 24 months. There was no difference in the level of improvement between the patients with and without diabetes, except in the SF-36v2 Physical Functioning, in which diabetic patients experienced significantly less improvement. There were no differences in surgical complication rates between diabetic patients and nondiabetic patients. Conclusions Except for a worse Nurick grade, diabetes does not seem to affect severity of symptoms at presentation for surgery. More importantly, with the exception of the SF-36v2 Physical Functioning scores, outcomes of surgical treatment are similar in patients with diabetes and without diabetes. Surgical decompression is effective and should be offered to patients with diabetes who have symptomatic CSM and are appropriate surgical candidates.
- Published
- 2014
35. 172 Role of the Sodium/Glutamate Blocker Riluzole in Enhancing Functional Outcomes in Patient Undergoing Surgery for Degenerative Cervical Myelopathy
- Author
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Paul M. Arnold, S. Tim Yoon, Henry Ahn, Darrel S. Brodke, Christopher I. Shaffrey, Kee D. Kim, Bradley Jacobs, Jason D Wilson, Michael G. Fehlings, K. Daniel Riew, Praveen V. Mummaneni, Carlo Santaguida, Alexander R. Vaccaro, Alan S. Hilibrand, Francis Farhadi, Ahmad Nassr, Daryl R. Fourney, Branko Kopjar, and James S. Harrop
- Subjects
medicine.medical_specialty ,Surrogate endpoint ,business.industry ,medicine.disease ,Sodium Glutamate ,Spinal cord ,Riluzole ,law.invention ,Surgery ,Grip strength ,Myelopathy ,medicine.anatomical_structure ,Randomized controlled trial ,law ,Medicine ,Neurology (clinical) ,Amyotrophic lateral sclerosis ,business ,medicine.drug - Published
- 2018
36. Wednesday, September 26, 2018 10:35 AM – 12:00 PM Cervical Spine Trauma
- Author
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Robert G. Grossman, Branko Kopjar, and Michael G. Fehlings
- Subjects
medicine.medical_specialty ,Double blinded ,business.industry ,Context (language use) ,Placebo ,Cervical spine ,law.invention ,Riluzole ,Matched cohort ,Randomized controlled trial ,law ,Internal medicine ,Acute spinal cord injury ,medicine ,Surgery ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,medicine.drug - Abstract
BACKGROUND CONTEXT There is convincing evidence from the preclinical realm that the pharmacologic agent riluzole attenuates certain aspects of the secondary injury cascade leading to diminished neurological tissue destruction in animal SCI models. The safety and pharmacokinetic profile of riluzole have been studied in a multicenter pilot study in 36 patients. Efficacy of riluzole in acute human SCI has not been established. PURPOSE This study aims to investigate efficacy of riluzole in acute SCI. STUDY DESIGN/SETTING This is an ongoing multicenter, international double-blinded phase III RCT. PATIENT SAMPLE A total of 351 patients with acute C4–C8 SCI and ASIA impairment grade A, B or C OUTCOME MEASURES Primary outcome is the change in ASIA motor score (AMS) between baseline and 180 days. Other outcomes include ASIA upper and lower extremity MS; ASIA sensory score; ASIA grade; SCIM); SF-36v2; EQ-5D and GRASSP. METHODS A total of 351 patients with acute C4–C8 SCI and ASIA impairment grade A, B or C randomized 1:1 to riluzole and placebo. Primary outcome is the change in ASIA motor score (AMS) between baseline and 180 days. Other outcomes include ASIA upper and lower extremity MS; ASIA sensory score; ASIA grade; SCIM); SF-36v2; EQ-5D and GRASSP. Two-stage sequential adaptive trial statistical design has 90% power to detect 9 points difference in the ASIA motor score at one-sidedalpha=.025. RESULTS A matched cohort analysis performed in the Phase I study showed that riluzole treated cervical SCI patients experienced an additional 15.5 points in AMS recovery at 90 days post injury. Although the phase I study was underpowered to investigate efficacy the current phase III study is poised to definitive address this question. To date, 112 subjects have been enrolled. Average age of the enrolled subjects is 48.0 (SD 16.4); 84% males. ASIA at arrival and preInjury status, ASIA grade A (48%), B (27%), C (25%). GRASSP 64.6 (SD 61.4), SF35v2 PCS 53.0(SD 9.0) SF36v2 MCS 54.3 (SD 11.5). CONCLUSIONS This is a Phase III study of riluzole in acute SCI. FDA DEVICE/DRUG STATUS Riluzole (Not approved for this indication).
- Published
- 2018
37. The Impact of Older Age on Functional Recovery and Quality of Life Outcomes after Surgical Decompression for Degenerative Cervical Myelopathy: Results from an Ambispective, Propensity-Matched Analysis from the CSM-NA and CSM-I International, Multi-Center Studies
- Author
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Branko Kopjar, Jetan H. Badhiwala, Jefferson R. Wilson, Alexander R. Vaccaro, Michael G. Fehlings, Jamie R F Wilson, and Fan Jiang
- Subjects
medicine.medical_specialty ,complications ,SF-36 ,lcsh:Medicine ,outcomes ,elderly ,Article ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Quality of life ,Internal medicine ,medicine ,030212 general & internal medicine ,mJOA ,Adverse effect ,old age ,business.industry ,lcsh:R ,General Medicine ,Functional recovery ,medicine.disease ,humanities ,3. Good health ,degenerative cervical myelopathy ,Cohort ,Orthopedic surgery ,Propensity score matching ,business ,030217 neurology & neurosurgery - Abstract
Background: The effect on functional and quality of life (QOL) outcomes of surgery in elderly degenerative cervical myelopathy (DCM) patients has not been definitively established. Objective: To evaluate the effect of older age on the functional and QOL outcomes after surgery in an international, multi-center cohort of patients with DCM. Methods: 107 patients aged over 70 years old (mean 75.6 ±, 4.4 years) were enrolled in the AOSpine CSM-North America and International studies. A propensity-matched cohort of 107 patients was generated from the remaining 650 adults aged <, 70 years old (mean 56.3 ±, 9.6 years), matched to gender, complexity of surgery, co-morbidities, and baseline functional impairment (modified Japanese Orthopedic Association scale (mJOA). Functional, disability, and QOL outcomes were compared at baseline and at two years post-operatively, along with peri-operative adverse events. Results: Both cohorts were equivalently matched. At two years, both cohorts showed significant functional improvement from the baseline but the magnitude was greater in the younger cohort (mJOA 3.8 (3.2&ndash, 4.4) vs. 2.6 (2.0&ndash, 3.3), p = 0.007). This difference between groups was also observed in the SF-36 physical component summary (PCS) and mental component summary (MCS) outcomes (p = <, 0.001, p = 0.007), but not present in the neck disability index (NDI) scores (p = 0.094). Adverse events were non-significantly higher in the elderly cohort (22.4% vs. 15%, p = 0.161). Conclusions: Elderly patients showed an improvement in functional and QOL outcomes after surgery for DCM, but the magnitude of improvement was less when compared to the matched younger adult cohort. An age over 70 was not associated with an increased risk of adverse events.
- Published
- 2019
38. Anterior Versus Posterior Surgical Approaches to Treat Cervical Spondylotic Myelopathy
- Author
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Robert Banco, Sean Barry, Sangwook Tim Yoon, Eric J. Woodard, Michael Janssen, Rick C. Sasso, Justin S. Smith, Jens R. Chapman, Paul Arnold, Darrel S. Brodke, Christopher I. Shaffrey, Alexander R. Vaccaro, Michael G. Fehlings, Mark B. Dekutoski, Ziya L. Gokaslan, Branko Kopjar, Christopher M. Bono, and Eric M. Massicotte
- Subjects
medicine.medical_specialty ,Decompression ,business.industry ,Evidence-based medicine ,medicine.disease ,Surgery ,Clinical trial ,Myelopathy ,Multicenter trial ,Orthopedic surgery ,medicine ,Physical therapy ,Orthopedics and Sports Medicine ,Observational study ,Neurology (clinical) ,Prospective cohort study ,business - Abstract
STUDY DESIGN A prospective observational multicenter study. OBJECTIVE To help solve the debate regarding whether the anterior or posterior surgical approach is optimal for patients with cervical spondylotic myelopathy (CSM). SUMMARY OF BACKGROUND DATA The optimal surgical approach to treat CSM remains debated with varying opinions favoring anterior versus posterior surgical approaches. We present an analysis of a prospective observational multicenter study examining outcomes of surgical treatment for CSM. METHODS A total of 278 subjects from 12 sites in North America received anterior/posterior or combined surgery at the discretion of the surgeon. This study focused on subjects who had either anterior or posterior surgery (n = 264, follow-up rate, 87%). Outcome measures included the modified Japanese Orthopedic Assessment scale, the Nurick scale, the Neck Disability Index, and the Short-Form 36 (SF-36) Health Survey version 2 Physical and Mental Component Scores. RESULTS One hundred and sixty-nine patients were treated anteriorly and 95 underwent posterior surgery. Anterior surgical cases were younger and had less severe myelopathy as assessed by mJOA and Nurick scores. There were no baseline differences in Neck Disability Index or SF-36 between the anterior and posterior cases. Improvement in the mJOA was significantly lower in the anterior group than posterior group (2.47 vs. 3.62, respectively, P < 0.01), although the groups started at different levels of baseline impairment. The extent of improvement in the Nurick Scale, Neck Disability Index, SF-36 version 2 Physical Component Score, and SF-36 version 2 Mental Component Score did not differ between the groups. CONCLUSION Patients with CSM show significant improvements in several health-related outcome measures with either anterior or posterior surgery. Importantly, patients treated with anterior techniques were younger, with less severe impairment and more focal pathology. We demonstrate for the first time that, when patient and disease factors are controlled for, anterior and posterior surgical techniques have equivalent efficacy in the treatment of CSM. LEVEL OF EVIDENCE 3.
- Published
- 2013
39. Clinical Evaluation of a Neuroprotective Drug in Patients With Cervical Spondylotic Myelopathy Undergoing Surgical Treatment
- Author
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Spyridon K. Karadimas, Branko Kopjar, Paul M. Arnold, Michael G. Fehlings, and Jefferson R. Wilson
- Subjects
medicine.medical_specialty ,MEDLINE ,Context (language use) ,Spinal Cord Diseases ,law.invention ,Physical medicine and rehabilitation ,Randomized controlled trial ,law ,medicine ,Humans ,Orthopedics and Sports Medicine ,Amyotrophic lateral sclerosis ,Randomized Controlled Trials as Topic ,Riluzole ,business.industry ,medicine.disease ,Interim analysis ,Combined Modality Therapy ,Clinical trial ,Neuroprotective Agents ,Treatment Outcome ,Clinical Trials, Phase III as Topic ,Spinal decompression ,Cervical Vertebrae ,Spondylosis ,Neurology (clinical) ,business ,medicine.drug - Abstract
Study design Descriptive article and narrative review. Objective To explain the rationale and design of the cervical spondylotic myelopathy (CSM)-Protect clinical trial that aims to elucidate the efficacy and safety of riluzole in the context of CSM. Summary of background data CSM is the most common cause of spinal cord-related dysfunction internationally. Although surgery is effective in preventing the progression of impairment, and in some cases improving functional outcomes, many patients continue to exhibit significant disability in the postoperative setting. Evidence from preclinical studies suggests that glutamate-related excitotoxicity may contribute to the pathology of CSM and that administration of the sodium and glutamate-blocking medication riluzole, when combined with spinal cord decompression, may mitigate this effect and improve neurobehavioral outcomes. Although riluzole is FDA approved and has been shown to be safe and effective in the context of amyotrophic lateral sclerosis, its efficacy and safety in the context of CSM remain unknown. Methods Descriptive article with narrative review of the literature. Results In addition to providing pertinent preclinical background on the topic, this descriptive article and narrative review discusses the design and current status of an ongoing phase III randomized controlled trial evaluating the efficacy and safety of riluzole, combined with surgical decompression, in the treatment of CSM. Conclusion On the basis of current projections, we estimate that the interim analysis for this study will take place in the spring of 2014, at which time an adaptive sample size adjustment may take place.
- Published
- 2013
40. Alternative Procedures for the Treatment of Cervical Spondylotic Myelopathy
- Author
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Branko Kopjar, Christopher K. Kepler, Jens R. Chapman, James S. Harrop, Michael G. Fehlings, Alexander R. Vaccaro, Paul M. Arnold, Justin S. Smith, and Christopher I. Shaffrey
- Subjects
medicine.medical_specialty ,business.industry ,Nonunion ,Subgroup analysis ,Bone healing ,medicine.disease ,Surgery ,Clinical trial ,Multicenter study ,medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,Complication ,Prospective cohort study ,business ,Odontoid fracture - Abstract
Study design Subgroup analysis of a prospective multicenter study. Objective Outcome analysis of nonoperatively treated elderly patients with type II odontoid fractures, including assessment of consequence of a fracture nonunion. Summary of background data Odontoid fractures are among the most common fractures in the elderly, and controversy exists regarding treatment. Methods Subgroup analysis of a prospective multicenter study of elderly patients (≥65 yr) with type II odontoid fracture. Neck Disability Index and Short-Form 36 (SF-36) version 2 were collected at baseline and 6 and 12 months. Fifty-eight (36.5%) of the 159 patients were treated nonoperatively. Results Of the 58 patients initially treated nonoperatively, 8 died within 90 days and were excluded. Of the remaining 50 patients, 11 (22.0%) developed nonunion, with 7 (63.6%) requiring surgery. Four of the 39 (10.3%) patients classified as having "successful union" required surgery due to late fracture displacement. Thus, 15 (30.0%) patients developed primary or secondary nonunion and 11 (22.0%) required surgery. The overall 12-month mortality was 14.0% (nonunion = 2, union = 5; P= 0.6407). For union and nonunion groups, Neck Disability Index and SF-36 version 2 declined significantly at 12 months compared with preinjury values (P 0.05); however, it is important to emphasize that the 12-month outcomes for the nonunion patients reflect the status of the patient after delayed surgical treatment in the majority of these cases. Conclusion Nonoperative treatment for type II odontoid fracture in the elderly has high rates of nonunion and mortality. Patients with nonunion did not report worse outcomes compared with those who achieved union at 12 months; however, the majority of patients with nonunion required delayed surgical treatment. These findings may prove useful for patients who are not surgical candidates or elect for nonoperative treatment. Level of evidence 2.
- Published
- 2013
41. A Clinical Prediction Model to Determine Outcomes in Patients with Cervical Spondylotic Myelopathy Undergoing Surgical Treatment
- Author
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Branko Kopjar, Lindsay Tetreault, Eric M. Massicotte, Alexander R. Vaccaro, Sangwook Tim Yoon, Michael G. Fehlings, and Paul M. Arnold
- Subjects
Adult ,Male ,medicine.medical_specialty ,Logistic regression ,Spinal Cord Diseases ,Spinal Osteophytosis ,Disability Evaluation ,Postoperative Complications ,Internal medicine ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,Aged ,Aged, 80 and over ,Univariate analysis ,medicine.diagnostic_test ,Receiver operating characteristic ,business.industry ,Magnetic resonance imaging ,General Medicine ,Odds ratio ,Middle Aged ,Decompression, Surgical ,Prognosis ,Magnetic Resonance Imaging ,Gait ,Confidence interval ,Surgery ,Treatment Outcome ,Spinal Cord ,North America ,Cervical Vertebrae ,Female ,Spondylosis ,business - Abstract
Background: Cervical spondylotic myelopathy is a progressive spine disease and the most common cause of spinal cord dysfunction worldwide. The objective of this study was to develop a prediction model, based on data from a prospective multi-center study, relating a combination of clinical and imaging variables to surgical outcome in patients with cervical spondylotic myelopathy. Methods: Two hundred and seventy-eight patients diagnosed with cervical spondylotic myelopathy treated surgically were enrolled at twelve different sites in the multi-center AOSpine North America study. Univariate analyses were performed to evaluate the relationship between outcome, assessed with the modified Japanese Orthopaedic Association (mJOA) score, and various clinical and imaging predictors. A set of important candidate variables for the final model was selected on the basis of author consensus, literature support, and statistical findings. Logistic regression was used to formulate the final model. Results: Univariate analyses demonstrated that the odds of a successful outcome decreased with a longer duration of symptoms (odds ratio [OR] = 0.80, 95% confidence interval [CI] = 0.65 to 0.98, p = 0.030); a lower baseline mJOA score (OR = 0.74, 95% CI = 0.65 to 0.84, p < 0.0001); the presence of psychological comorbidities (OR = 0.51, 95% CI = 0.29 to 0.92, p = 0.024); the presence of broad-based, unstable gait (OR = 2.72, 95% CI = 1.47 to 5.06, p = 0.0018) or other gait impairment (OR = 3.56, 95% CI = 1.75 to 7.22, p = 0.0005); and older age (OR = 0.96, 95% CI = 0.93 to 0.98, p = 0.0004). The dependent variable, the mJOA score at one year, was dichotomized for logistic regression: a “successful” outcome was defined as a final score of ≥16 and a “failed” outcome was a score of
- Published
- 2013
42. Cancer Risk After Use of Recombinant Bone Morphogenetic Protein-2 for Spinal Arthrodesis
- Author
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Eugene J. Carragee, Eric L. Hurwitz, Rajat Rohatgi, Branko Kopjar, Garet C. Comer, Bradley K. Weiner, S. Tim Yoon, and Gilbert Chu
- Subjects
Adult ,Male ,medicine.medical_specialty ,Arthrodesis ,medicine.medical_treatment ,Bone Morphogenetic Protein 2 ,Rate ratio ,law.invention ,Lumbar ,Randomized controlled trial ,law ,Neoplasms ,medicine ,Humans ,Orthopedics and Sports Medicine ,Aged ,Randomized Controlled Trials as Topic ,Bone Transplantation ,Lumbar Vertebrae ,business.industry ,Incidence ,Incidence (epidemiology) ,Cancer ,Spinal arthrodesis ,General Medicine ,Middle Aged ,medicine.disease ,Recombinant Proteins ,Confidence interval ,Surgery ,Spinal Fusion ,Female ,Spinal Diseases ,business ,Follow-Up Studies - Abstract
Background: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a growth factor known to have in vitro effects on the growth and invasiveness of cancer. It has been approved by the U.S. Food and Drug Administration in limited doses for single-level anterior spinal arthrodesis, but it is commonly used off-label and at high doses. The effect of rhBMP-2 on the risk of cancer has been a concern. We sought to evaluate the risk of new cancers in patients receiving high-dose rhBMP-2. Methods: We used publicly available data from a pivotal, multicenter, randomized controlled trial of patients with degenerative lumbar spine conditions who underwent a single-level instrumented posterolateral arthrodesis with either high-dose rhBMP-2 in a compression-resistant matrix (CRM) (rhBMP-2/CRM; n = 239) or autogenous bone graft (control group; n = 224). We compared the risks of new cancers in the rhBMP-2/CRM and control groups at two and five years after surgery. Results: At two years, with 86% follow-up, there were fifteen new cancer events in eleven patients in the rhBMP-2/CRM group compared with two new cancer events in two patients in the control group treated with autogenous bone graft. The incidence rate of new cancer events per 100 person-years was 3.37 (95% confidence interval [CI], 1.89 to 5.56) in the rhBMP-2/CRM group at two years compared with 0.50 (95% CI, 0.06 to 1.80) in the control group. The incidence rate ratio was 6.75 (95% CI, 1.57 to 60.83; p = 0.0026) at two years. Calculated in terms of the number of patients with one or more cancer events two years after the surgery, the incidence rate per 100 person-years was 2.54 (95% CI, 1.27 to 4.54) in the rhBMP-2/CRM group compared with 0.50 (95% CI, 0.06 to 1.82) in the control group at two years; the incidence rate ratio was 5.04 (95% CI, 1.10 to 46.82; p = 0.0194). At five years, there was a 37% loss of follow-up, but a significantly greater incidence of cancer events was still observed in the rhBMP-2/CRM group. Conclusions: A high dose of 40 mg of rhBMP-2/CRM in lumbar spinal arthrodesis was associated with an increased risk of new cancer. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Published
- 2013
43. The AOSpine North America Geriatric Odontoid Fracture Mortality Study
- Author
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Jens R. Chapman, Christopher I. Shaffrey, Alexander R. Vaccaro, Michael G. Fehlings, Branko Kopjar, Justin S. Smith, and Paul M. Arnold
- Subjects
education.field_of_study ,medicine.medical_specialty ,business.industry ,Mortality rate ,Population ,Nonunion ,Retrospective cohort study ,medicine.disease ,Surgery ,Pseudarthrosis ,Myelopathy ,Cohort ,Medicine ,Orthopedics and Sports Medicine ,Neurology (clinical) ,business ,education ,Survival rate - Abstract
The high incidence of spine fractures in the elderly, coupled with the rapid expansion of this segment of the population in the United States, prompted the recent description of spine fractures in the geriatric population as a serious emerging health care crisis.1 The population of the United States older than 65 years is expected to double to more than 70 million between the years 2000 and 2030,2 and the population older than 85 years is the fastest growing age group, expected to double by 2025 and quintuple by 2050.1,3 Odontoid fractures are among the most common spine fractures in general, but in the elderly, these injuries are the most common isolated spine fracture.4,5 A majority of these are classified as type II fractures on the basis of the classification by Anderson and D'Alonzo.6 A recent report has demonstrated that the number and frequency of type II odontoid fractures, in comparison with other spine injuries, seems to be increasing during the past 2 decades and may correlate with the increasing elderly population.7 There is controversy regarding whether operative or nonoperative management is the best treatment option for elderly patients with type II odontoid fractures.8–12 Type II fractures by definition occur through the base of the dens, which in comparison with the body of the C2 vertebra, has a less robust blood supply and bone quality, and together with its high-strain location renders this fracture more vulnerable to nonunion.13 This risk of nonunion seems to be particularly high in the elderly, in which the rate of pseudarthrosis has been reported to be as high as 85% with nonoperative management.14 In contrast, fusion rates of up to 100% have been reported with posterior C1–C2 instrumentation.15 However, surgical treatment in these often medically compromised patients is also associated with adverse outcomes, with a recent report documenting a mortality rate of 19.2% and major complication rate of 27% in an operatively treated cohort of elderly patients with type II odontoid fractures.16 Adding to the controversy of management of type II odontoid fractures has been uncertainty regarding the clinical significance of chronic fracture nonunion. Reports from Crockard et al17 and Kirankumar et al18 had raised the concern of delayed myelopathy in the setting of nonunion. However, a case series by Hart et al19 suggested that development of delayed myelopathy in the setting of pseudarthrosis of type II odontoid fracture in the elderly to be a rare event. A subsequent report further endorsed a lack of correlation between fracture healing and clinical outcomes.11 Thus, the optimal management of elderly patients with type II odontoid fractures remains controversial, with advocates of both operative and nonoperative approaches.20,21 Our objectives in this study were to evaluate short- and long-term mortality in geriatric patients with type II odontoid fracture and to assess whether these mortality rates differed significantly based on operative versus nonsurgical treatment approach.
- Published
- 2013
44. Functional and Quality-of-Life Outcomes in Geriatric Patients with Type-II Dens Fracture
- Author
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Alexander R. Vaccaro, Christopher K. Kepler, Branko Kopjar, Jens Chapman, Christopher Shaffrey, Paul Arnold, Ziya Gokaslan, Darrel Brodke, John France, Mark Dekutoski, Rick Sasso, S. Tim Yoon, Christopher Bono, James Harrop, and Michael G. Fehlings
- Subjects
Male ,medicine.medical_specialty ,medicine.medical_treatment ,Arthrodesis ,Cohort Studies ,Immobilization ,Quality of life ,Odontoid Process ,Humans ,Medicine ,Orthopedics and Sports Medicine ,Prospective cohort study ,Aged ,business.industry ,Mortality rate ,Confounding ,Age Factors ,Recovery of Function ,General Medicine ,Surgery ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,Cohort ,Quality of Life ,Spinal Fractures ,Female ,business ,Cohort study - Abstract
Background: Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older. Methods: One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables. Results: The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p < 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059). Conclusions: We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.
- Published
- 2013
45. Impact of Depression and Bipolar Disorders on Functional and Quality of Life Outcomes in Patients Undergoing Surgery for Degenerative Cervical Myelopathy: Analysis of a Combined Prospective Dataset
- Author
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Lindsay, Tetreault, Narihito, Nagoshi, Hiroaki, Nakashima, Anoushka, Singh, Branko, Kopjar, Paul, Arnold, and Michael G, Fehlings
- Subjects
Adult ,Aged, 80 and over ,Male ,Bipolar Disorder ,Depression ,Middle Aged ,Decompression, Surgical ,Spinal Cord Diseases ,Spinal Fusion ,Treatment Outcome ,Cervical Vertebrae ,Quality of Life ,Humans ,Female ,Prospective Studies ,Aged - Abstract
Analysis of a combined prospective dataset.To compare clinical outcomes in patients with and without preexisting depression or bipolar disorder undergoing surgery for degenerative cervical myelopathy (DCM).Psychiatric comorbidities, including depression, have been associated with worse clinical outcomes after lumbar spine surgery; however, it is unclear whether these psychiatric disorders are also predictive of outcomes in patients undergoing surgery for the treatment of DCM.Four hundred and one patients with symptomatic DCM were enrolled in the prospective AOSpine International or North America study at twelve North American sites. Patients were evaluated preoperatively and at 6, 12, and 24 months using the modified Japanese Orthopedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short- Form 36v2 (SF-36v2) Health Survey. A mixed model analytic approach was used to evaluate differences in outcomes at 24 months among patients with and without psychiatric disorders, while controlling for relevant baseline characteristics and surgical factors.Ninety-seven patients (24.19%) were diagnosed with preexisting depression or bipolar disorder. There were more females (65.98%) with these psychiatric disorders than males (34.02%) (P 0.0001). Patients with psychiatric comorbidities were more likely to have cardiovascular (P = 0.0177), respiratory (P 0.0001), gastrointestinal (P 0.0001), rheumatologic (P = 0.0109), and neurologic (P = 0.0309) disorders. At 24 months after surgery, patients in both groups demonstrated significant improvements on the mJOA, Nurick, NDI, and SF-36v2 Physical Component Score (PCS). Patients with depression or bipolar disorder, however, did not exhibit a significant or clinically important change on the SF-36v2 Mental Component Score (MCS). There were no differences in mJOA and Nurick scores at 24 months among patients in each group. Improvement in NDI, SF-36v2 PCS, and MCS, however, were smaller in patients with depression or bipolar disorder than those without.Patients with depression or bipolar disorder have smaller functional and quality of life improvements after surgery compared to patients without psychiatric comorbidities.2.
- Published
- 2016
46. Do Caucasians and East Asians have Different Outcomes Following Surgery for the Treatment of Degenerative Cervical Myelopathy?: Results From the Prospective Multicenter AOSpine International Study
- Author
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Hiroaki Nakashima, Gamaliel Tan, Paul M. Arnold, Narihito Nagoshi, Mehmet Zileli, Aria Nouri, Lindsay Tetreault, Michael G. Fehlings, and Branko Kopjar
- Subjects
Adult ,Male ,medicine.medical_specialty ,Prevalence ,White People ,03 medical and health sciences ,Myelopathy ,Disability Evaluation ,0302 clinical medicine ,Asian People ,medicine ,Humans ,Orthopedics and Sports Medicine ,030212 general & internal medicine ,Prospective Studies ,Aged ,business.industry ,Incidence (epidemiology) ,Perioperative ,Middle Aged ,medicine.disease ,Decompression, Surgical ,Prognosis ,Surgery ,Treatment Outcome ,Baseline characteristics ,Orthopedic surgery ,Cervical Vertebrae ,Functional status ,Female ,Spinal Diseases ,Neurology (clinical) ,business ,Spinal Cord Compression ,030217 neurology & neurosurgery ,Cohort study - Abstract
STUDY DESIGN A prospective multicenter cohort study. OBJECTIVE The aim of this study was to compare outcomes of surgery for the treatment for degenerative cervical myelopathy (DCM) between Caucasians and East Asians. SUMMARY OF BACKGROUND DATA Numerous studies have indicated that race can influence both disease prevalence and clinical prognosis in a variety of medical conditions; however, none have evaluated the impact of race on surgical outcomes in patients with DCM. METHODS Four hundred and seventy-nine patients with symptomatic DCM were enrolled in the prospective AOSpine CSM-International study at 16 global sites. Preoperatively, and at each follow-up, patients were evaluated using the modified Japanese Orthopedic Association scale (mJOA), the Nurick score, the Neck Disability Index (NDI), and the Short- Form 36 (SF-36) Health Survey. A mixed-model analytic approach was used to evaluate differences in outcomes between races at 24 months postoperatively, while controlling for relevant baseline characteristics and surgical factors. RESULTS Three hundred and twenty-four (67.64%) patients were Caucasian and 106 (22.13%) were East Asian. There was no difference in the incidence of ossification of the posterior longitudinal ligament (OPLL) between the two races; however a greater percentage of Caucasians in India (46.15%) and Turkey (41.38%) displayed evidence of OPLL than Caucasians in other regions (P
- Published
- 2016
47. The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study
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Matthew F. Gornet, Branko Kopjar, Francine W. Schranck, and Anne G. Copay
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Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Workers' compensation ,Risk Assessment ,Severity of Illness Index ,Arthroplasty ,Cohort Studies ,03 medical and health sciences ,Disability Evaluation ,0302 clinical medicine ,Lumbar ,Return to Work ,medicine ,Humans ,Orthopedics and Sports Medicine ,Prospective Studies ,Prospective cohort study ,Pain Measurement ,030222 orthopedics ,Neck pain ,Analysis of Variance ,Chi-Square Distribution ,business.industry ,General Medicine ,Recovery of Function ,Middle Aged ,Surgery ,medicine.anatomical_structure ,Spinal Fusion ,Treatment Outcome ,Patient Satisfaction ,Spinal fusion ,Cervical Vertebrae ,Workers' Compensation ,Female ,Self Report ,medicine.symptom ,business ,030217 neurology & neurosurgery ,Intervertebral Disc Displacement ,Cervical vertebrae ,Cohort study ,Follow-Up Studies - Abstract
Background: Receiving Workers’ Compensation benefits has been associated with inferior outcomes after lumbar fusion. The purpose of our study was to compare the outcomes of cervical disc arthroplasty between patients receiving and those not receiving Workers’ Compensation. Methods: Patient-reported outcomes, reoperations, complications, and return-to-work status were analyzed at one year after surgery in an observational cohort of consecutive patients who underwent single-level or multilevel cervical disc arthroplasty for symptomatic cervical disc conditions, including radiculopathy or discogenic pain with or without radiculopathy, exclusive of myelopathy. Results: Of the 189 patients who underwent cervical disc arthroplasty, 144 received Workers’ Compensation and forty-five did not. The mean scores on all patient-reported measures improved significantly from preoperative baseline to one year after surgery (p < 0.001), and the improvement in patient-reported outcomes did not differ significantly between the Workers’ Compensation and the non-Workers’ Compensation group (respectively, 22.7 compared with 25.0 for the Neck Disability Index; 8.3 compared with 9.6 for the Short Form (SF)-36 physical component summary; 7.9 compared with 9.6 for the SF-36 mental component summary; 3.5 compared with 3.7 for neck pain; and 2.6 compared with 2.8 for arm pain). The two groups also did not differ significantly in the rate of reoperations (7.6% for those receiving Workers’ Compensation compared with 13.3% for those not receiving Workers’ Compensation) and complications (2.8% compared with 4.4%, respectively). At one year after surgery, the proportion of patients who had returned to work was comparable (77.7% in the Workers’ Compensation group and 79.4% in the non-Workers’ Compensation group); however, the patients receiving Workers’ Compensation had significantly more days off before returning to work (a mean of 145.2 compared with 61.9 days; p = 0.001). Conclusions: After cervical disc arthroplasty, patients receiving Workers’ Compensation had outcomes that were similar to those of patients not receiving Workers’ Compensation in terms of patient-reported outcomes, surgery-related complications, reoperations, and return-to-work status. Patients receiving Workers’ Compensation remained off work for a longer interval than did patients not receiving Workers’ Compensation. Level of Evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
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- 2016
48. Does age affect surgical outcomes in patients with degenerative cervical myelopathy ? Results from the prospective multicenter AOSpine International study on 479 patients
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Hiroaki Nakashima, Paul M. Arnold, Shashank S. Kale, Lindsay Tetreault, Narihito Nagoshi, Branko Kopjar, Michael G. Fehlings, Ronald H. M. A. Bartels, Aria Nouri, Helton Luiz Aparecido Defino, and Qiang Zhou
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Male ,medicine.medical_specialty ,Decompression ,medicine.medical_treatment ,MEDLINE ,Neurosurgery ,03 medical and health sciences ,Myelopathy ,Disability Evaluation ,0302 clinical medicine ,Postoperative Complications ,Quality of life ,Spinal cord compression ,Internal medicine ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Aged ,IDOSOS ,business.industry ,Age Factors ,Neurodegenerative Diseases ,Middle Aged ,medicine.disease ,Decompression, Surgical ,Surgery ,Reconstructive and regenerative medicine Radboud Institute for Health Sciences [Radboudumc 10] ,Psychiatry and Mental health ,medicine.anatomical_structure ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,Cervical Vertebrae ,Quality of Life ,Female ,Neurology (clinical) ,business ,Spinal Cord Compression ,030217 neurology & neurosurgery ,Cervical vertebrae ,Diskectomy - Abstract
Contains fulltext : 172337.pdf (Publisher’s version ) (Open Access) BACKGROUND: In general, older patients with degenerative cervical myelopathy (DCM) are felt to have lower recovery potential following surgery due to increased degenerative pathology, comorbidities, reduced physiological reserves and age-related changes to the spinal cord. This study aims to determine whether age truly is an independent predictor of surgical outcome and to provide evidence to guide practice and decision-making. METHODS: A total of 479 patients with DCM were prospectively enrolled in the CSM-International study at 16 centres. Our sample was divided into a younger group (/=65 years) group. A mixed model analytic approach was used to evaluate differences in the modified Japanese Orthopaedic Association (mJOA), Nurick, Short Form-36 (SF-36) and Neck Disability Index (NDI) scores between groups. We first created an unadjusted model between age and surgical outcome and then developed two adjusted models that accounted for variations in (1) baseline characteristics and (2) both baseline and surgical factors. RESULTS: Of the 479 patients, 360 (75.16%) were /=65 years. Elderly patients had a worse preoperative health status (p
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- 2016
49. Risk Factors and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery in Patients With Degenerative Cervical Myelopathy: Results From the AOSpine International and North America Studies
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Paul M. Arnold, Lindsay Tetreault, Branko Kopjar, Michael G. Fehlings, Narihito Nagoshi, Hiroaki Nakashima, and Giuseppe Barbagallo
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medicine.medical_specialty ,business.industry ,important risk factors have not been rigorously evaluated. Furthermore ,medicine.disease ,Dysphagia ,Cervical surgery ,the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia ,Surgery ,in patients treated with anterior cervical decompression and fusion ,03 medical and health sciences ,Myelopathy ,0302 clinical medicine ,Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion ,Although dysphagia is a common complication after anterior cervical decompression and fusion ,030220 oncology & carcinogenesis ,medicine ,and the impact of this complication on short and long-term clinical outcomes ,Orthopedics and Sports Medicine ,In patient ,Neurology (clinical) ,medicine.symptom ,business ,030217 neurology & neurosurgery - Published
- 2016
50. Perioperative and delayed complications associated with the surgical treatment of cervical spondylotic myelopathy based on 302 patients from the AOSpine North America Cervical Spondylotic Myelopathy Study
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S. Tim Yoon, Darrel S. Brodke, Jens R. Chapman, Robert Banco, Rick C. Sasso, Justin S. Smith, Eric J. Woodard, Paul M. Arnold, Alexander R. Vaccaro, Mark B. Dekutoski, Branko Kopjar, Christopher I. Shaffrey, Michael G. Fehlings, Christopher M. Bono, Michael Janssen, Ziya L. Gokaslan, and Eric M. Massicotte
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Adult ,Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Myelopathy ,Risk Factors ,medicine ,Humans ,Adverse effect ,Aged ,Retrospective Studies ,Aged, 80 and over ,business.industry ,Incidence (epidemiology) ,Laminectomy ,Retrospective cohort study ,General Medicine ,Perioperative ,Middle Aged ,Decompression, Surgical ,medicine.disease ,Dysphagia ,Surgery ,Spinal Fusion ,Treatment Outcome ,Spinal fusion ,North America ,Cervical Vertebrae ,Female ,Spondylosis ,medicine.symptom ,Complication ,business - Abstract
Object Rates of complications associated with the surgical treatment of cervical spondylotic myelopathy (CSM) are not clear. Appreciating these risks is important for patient counseling and quality improvement. The authors sought to assess the rates of and risk factors associated with perioperative and delayed complications associated with the surgical treatment of CSM. Methods Data from the AOSpine North America Cervical Spondylotic Myelopathy Study, a prospective, multicenter study, were analyzed. Outcomes data, including adverse events, were collected in a standardized manner and externally monitored. Rates of perioperative complications (within 30 days of surgery) and delayed complications (31 days to 2 years following surgery) were tabulated and stratified based on clinical factors. Results The study enrolled 302 patients (mean age 57 years, range 29–86) years. Of 332 reported adverse events, 73 were classified as perioperative complications (25 major and 48 minor) in 47 patients (overall perioperative complication rate of 15.6%). The most common perioperative complications included minor cardiopulmonary events (3.0%), dysphagia (3.0%), and superficial wound infection (2.3%). Perioperative worsening of myelopathy was reported in 4 patients (1.3%). Based on 275 patients who completed 2 years of follow-up, there were 14 delayed complications (8 minor, 6 major) in 12 patients, for an overall delayed complication rate of 4.4%. Of patients treated with anterior-only (n = 176), posterior-only (n = 107), and combined anterior-posterior (n = 19) procedures, 11%, 19%, and 37%, respectively, had 1 or more perioperative complications. Compared with anterior-only approaches, posterior-only approaches had a higher rate of wound infection (0.6% vs 4.7%, p = 0.030). Dysphagia was more common with combined anterior-posterior procedures (21.1%) compared with anterior-only procedures (2.3%) or posterior-only procedures (0.9%) (p < 0.001). The incidence of C-5 radiculopathy was not associated with the surgical approach (p = 0.8). The occurrence of perioperative complications was associated with increased age (p = 0.006), combined anterior-posterior procedures (p = 0.016), increased operative time (p = 0.009), and increased operative blood loss (p = 0.005), but it was not associated with comorbidity score, body mass index, modified Japanese Orthopaedic Association score, smoking status, anterior-only versus posterior-only approach, or specific procedures. Multivariate analysis of factors associated with minor or major complications identified age (OR 1.029, 95% CI 1.002–1.057, p = 0.035) and operative time (OR 1.005, 95% CI 1.002–1.008, p = 0.001). Multivariate analysis of factors associated with major complications identified age (OR 1.054, 95% CI 1.015–1.094, p = 0.006) and combined anterior-posterior procedures (OR 5.297, 95% CI 1.626–17.256, p = 0.006). Conclusions For the surgical treatment of CSM, the vast majority of complications were treatable and without long-term impact. Multivariate factors associated with an increased risk of complications include greater age, increased operative time, and use of combined anterior-posterior procedures.
- Published
- 2012
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