Search

Study Design: Secondary analysis of data from the multicenter, randomized, parallel-controlled Food and Drug Administration (FDA) investigational device exemption study. Objective: Studies on outcomes following anterior cervical discectomy and fusion (ACDF) in individuals with diabetes are scarce. We compared 24-month radiological and clinical outcomes in individuals with and without diabetes undergoing single-level ACDF with either i-FACTOR or local autologous bone. Methods: Between 2006 and 2013, 319 individuals with single-level degenerative disc disease (DDD) and no previous fusion at the index level underwent ACDF. The presence of diabetes determined the 2 cohorts. Data collected included radiological fusion evaluation, neurological outcomes, Neck Disability Index (NDI), Visual Analog Scale (VAS) scores, and the 36-Item Short Form Survey Version 2 (SF-36v2) Physical and Mental component summary scores. Results: There were 35 individuals with diabetes (11.1%; average body mass index [BMI] = 32.99 kg/m2; SD = 5.72) and 284 without (average BMI = 28.32 kg/m2; SD = 5.67). The number of nondiabetic smokers was significantly higher than diabetic smokers: 73 (25.70%) and 3 (8.57%), respectively. Preoperative scores of NDI, VAS arm pain, and SF-36v2 were similar between the diabetic and nondiabetic participants at baseline; however, VAS neck pain differed significantly between the cohorts at baseline ( P = .0089). Maximum improvement for NDI, VAS neck and arm pain, and SF-36v2 PCS and MCS scores was seen at 6 months in both cohorts and remained stable until 24 months. Conclusions: ACDF is effective for cervical radiculopathy in patients with diabetes. Diabetes is not a contraindication for patients requiring single-level surgery for cervical DDD.

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.

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

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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

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.

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.

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.

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.

Item does not contain fulltext PURPOSE: We aimed to determine cut-offs between mild, moderate and severe myelopathy on the modified Japanese Orthopedic Association (mJOA) score. METHODS: Between December 2005 and January 2011, 757 patients with clinically diagnosed DCM were enrolled in the prospective AOSpine North America (n = 278) or International (n = 479) study at 26 sites. Functional status and quality of life were evaluated at baseline using a variety of outcome measures. Using the Nurick score as an anchor, receiver operating curve (ROC) analysis was conducted to determine cut-offs between mild, moderate and severe disease. The validity of the identified cut-offs was evaluated by examining whether patients in different severity groups differed in terms of impairment, disability, quality of life and number of signs and symptoms. RESULTS: A mJOA of 14 was determined to be the cut-off between mild and moderate myelopathy and a mJOA of 11 was the cut-off score between moderate and severe disease. Patients in the severe myelopathy group (n = 254) had significantly reduced quality of life and functional status and a greater number of signs and symptoms compared to patients classified as mild (n = 190) or moderate (n = 296). CONCLUSIONS: Mild myelopathy can be defined as mJOA from 15 to 17, moderate as mJOA from 12 to 14 and severe as mJOA from 0 to 11. These categories should be adopted worldwide to standardize clinical assessment of DCM.

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.

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 &plusmn, 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 &lt, 70 years old (mean 56.3 &plusmn, 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 = &lt, 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.

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.

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.

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.

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.

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.

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

It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM).The objective of this study is to compare outcomes of LP and LF.This is a multicenter international prospective cohort study.A total of 266 surgically treated symptomatic DCM patients undergoing cervical decompression using LP (N=100) or LF (N=166) were included.The outcome measures were the modified Japanese Orthopaedic Association score (mJOA), Nurick grade, Neck Disability Index (NDI), Short-Form 36v2 (SF36v2), length of hospital stay, length of stay in the intensive care unit, treatment complications, and reoperations.Differences in outcomes between the LP and LF groups were analyzed by analysis of variance and analysis of covariance. The dependent variable in all analyses was the change score between baseline and 24-month follow-up, and the independent variable was surgical procedure (LP or LF). In the analysis of covariance, outcomes were compared between cohorts while adjusting for gender, age, smoking, number of operative levels, duration of symptoms, geographic region, and baseline scores.There were no differences in age, gender, smoking status, number of operated levels, and baseline Nurick, NDI, and SF36v2 scores between the LP and LF groups. Preoperative mJOA was lower in the LP compared with the LF group (11.52±2.77 and 12.30±2.85, respectively, p=.0297). Patients in both groups showed significant improvements in mJOA, Nurick grade, NDI, and SF36v2 physical and mental health component scores 24 months after surgery (p.0001). At 24 months, mJOA scores improved by 3.49 (95% confidence interval [CI]: 2.84, 4.13) in the LP group compared with 2.39 (95% CI: 1.91, 2.86) in the LF group (p=.0069). Nurick grades improved by 1.57 (95% CI: 1.23, 1.90) in the LP group and 1.18 (95% CI: 0.92, 1.44) in the LF group (p=.0770). There were no differences between the groups with respect to NDI and SF36v2 outcomes. After adjustment for preoperative characteristics, surgical factors and geographic region, the differences in mJOA between surgical groups were no longer significant. The rate of treatment-related complications in the LF group was 28.31% compared with 21.00% in the LP group (p=.1079).Both LP and LF are effective at improving clinical disease severity, functional status, and quality of life in patients with DCM. In an unadjusted analysis, patients treated with LP achieved greater improvements on the mJOA at 24-month follow-up than those who received LF; however, these differences were insignificant following adjustment for relevant confounders.

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

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.

Background Context The timed 30-m walking test (30MWT) is used in clinical practice and in research to objectively quantify gait impairment. The psychometric properties of 30MWT have not yet been rigorously evaluated. Purpose This study aimed to determine test-retest reliability, divergent and convergent validity, and responsiveness to change of the 30MWT in patients with degenerative cervical myelopathy (DCM). Study Design/Setting A retrospective observational study was carried out. Patient Sample The sample consisted of patients with symptomatic DCM enrolled in the AOSpine North America or AOSpine International cervical spondylotic myelopathy studies at 26 sites. Outcome Measures Modified Japanese Orthopaedic Association scale (mJOA), Nurick scale, 30MWT, Neck Disability Index (NDI), and Short-Form-36 (SF-36v2) physical component score (PCS) and mental component score (MCS) were the outcome measures. Methods Data from two prospective multicenter cohort myelopathy studies were merged. Each patient was evaluated at baseline and 6 months postoperatively. Results Of 757 total patients, 682 (90.09%) attempted to perform the 30MWT at baseline. Of these 682 patients, 602 (88.12%) performed the 30MWT at baseline. One patient was excluded, leaving601 in the analysis. At baseline, 81 of 682 (11.88%) patients were unable to perform the test, and their mJOA, NDI, and SF-36v2 PCS scores were lower compared with those who performed the test at baseline. In patients who performed the 30MWT at baseline, there was very high correlation among the three baseline 30MWT measurements (r=0.9569–0.9919). The 30MWT demonstrated good convergent and divergent validity. It was moderately correlated with the Nurick (r=0.4932), mJOA (r=−0.4424), and SF-36v2 PCS (r=−0.3537) (convergent validity) and poorly correlated with the NDI (r=0.2107) and SF-36v2 MCS (r=−0.1984) (divergent validity). Overall, the 30MWT was not responsive to change (standardized response mean [SRM]=0.30). However, for patients who had a baseline time above the median value of 29 seconds, the SRM was 0.45. Conclusions The 30MWT shows high test-retest reliability and good divergent and convergent validity. It is responsive to change only in patients with more severe myelopathy. The 30MWT is a simple, quick, and affordable test, and should be used as an ancillary test to evaluate gait parameters in patients with DCM.

Background: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. Methods: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. Results: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. Conclusions: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Intertrochanteric hip fractures have become more common as the elderly population continues to increase, and surgical stabilisation of these fractures remains a persistent challenge. The purpose of this study was to analyse the ability of a new helical blade device to stabilise intertrochanteric hip fractures, and to further determine which factors are important in implant stability.Two hundred and fifty-five patients with an intertrochanteric hip fracture were treated with a trochanteric fixation nail (TFN), 97 of whom fit strict radiographic and follow-up criteria and were included in the study group. After adjusting for magnification and rotation, blade migration within the femoral head and telescoping of the blade along its axis were measured using a custom-designed grid system. Multivariate regression analyses were performed to determine which variables predicted blade migration and telescoping.Fifty-nine fractures were classified as stable, and the remaining 38 were unstable. Mean telescoping was 4.3 mm in the unstable group, compared to 2.6 mm in the stable group (p0.05). Blade migration within the femoral head averaged 2.2 mm overall, with no difference between stable and unstable fractures. For both telescoping and blade migration, no significant change occurred after the 6-week time point in the stable or unstable group. Nail length, age, and gender did not have a significant effect on either blade migration or telescoping implant position change. Of the initial cohort of 255 patients, five cutouts and one nonunion occurred, three of which required subsequent procedures.Subtle migration ( approximately 2mm) of the tip of the blade within the femoral head occurred in all fractures, but this did not preclude maintenance of reduction and fracture healing, and was not predicted by fracture type, reduction quality, age, or gender. More telescoping occurred in unstable compared to stable fractures, but this averaged 4mm and did not affect stable fixation or fracture healing. All position changes occurred within the first 6 weeks postoperatively, with no subsequent detectable migration or telescoping. Clinical correlations will be needed in the future to determine the significance of small amounts of migration or differences in telescoping, but this device appears to provide effective fixation in both stable and unstable intertrochanteric hip fractures.

Substance abuse remains one of the nation's most important public health problems resulting in significant morbidity and premature mortality (National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse 1998;Office of National Drug Control Policy 2001). Current national data reported by the 2000 National Household Survey on Drug Abuse (NHSDA) indicate that 15.4 percent of persons aged 18 years and older used illicit drugs during the past year, while 8.8 percent were current (past month) users (Office of Applied Studies, Substance Abuse and Mental Health Services Administration 2002). Heavy drinking (drinking five or more drinks on the same occasion on each of five or more days in the past 30 days) was reported by 7.3 percent of the population. Persons aged 18 to 25 had the highest reported rates of current illicit drug use and heavy drinking, 15.9 percent and 12.8 percent, respectively. Considerable attention has focused on substance abuse as a risk factor for occupational injuries and accidents (Alleyne, Stuart and Copes 1991;Lehman and Simpson 1992;National Research Council 1994;Gust and Walsh 1989). Widely publicized accidents in which drug or alcohol use was implicated, in particular, the aircraft crash on the carrier Nimitz, a passenger train crash in Chase, Maryland, involving the deaths of 16 people, and, more recently, the catastrophic oil spill in Alaska involving the Exxon Valdez tanker, heightened public concern about the role of substance abuse in workplace accidents. Studies have produced somewhat conflicting evidence regarding the risk gradient of alcohol and drug use for occupational injuries due, in part, to differences in research methods, measures, and study populations and settings. Some studies have failed to show a link between alcohol and drug use and occupational injuries or have shown only a weak link (Parish 1989;Hertz and Emmett 1986;Normand, Salyards and Mahoney 1990). Other studies have documented a clearer link, with the risk of occupational injury associated with substance use rising by 50 percent to 100 percent depending upon the substance used (alcohol, marijuana, other drugs) and the frequency and amount of use (Zwerling, Ryan and Orav 1990;Hingson, Lederman and Walsh 1985;Gutierrez-Fisac, Regidor and Ronda 1992;Pollock et al. 1998; Moll van Charante and Mulder 1990; Lewis and Cooper 1989). Beyond increasing the risk of occupational injuries, substance abuse has adverse effects on other workplace outcomes, including absenteeism, turnover, and disciplinary actions (Normand, Salyards and Mahoney 1990;Zwerling, Ryan and Orav 1990;Substance Abuse and Mental Health Services Administration 1999;Bush and Autry 2002). In response to growing national concern over the problem of substance abuse and its effect on workplace safety and productivity, the federal government in 1986 established by executive order the Federal Drug-Free Work-place Program. This federal initiative defined a model drug-free workplace (DFW) program that included the following components (Bush and Autry 2002): (1) a written policy describing the employer's expectations about drug use and consequences of policy violations; (2) an employee assistance program (EAP) to provide confidential problem assessment, counseling, referral to treatment, and follow-up support after treatment; (3) supervisor training to orient supervisors to the employer's drug abuse policy, to define the supervisor's responsibility to refer employees when job performance deficits are noted, and to recognize and respond to employees with problems; (4) employee education to describe the signs and symptoms of drug abuse and its effects on performance and to explain the program; and (5) drug testing on a controlled and carefully monitored basis. Following the federal initiative, private employers and public sector agencies adopted DFW programs. Reliable data on the use of DFW programs are unavailable, but surveys suggest that workplace substance abuse prevention activities, especially drug testing, are now used by more than one-half to two-thirds of major U.S. businesses (Bush and Autry 2002). Despite the importance attached to substance abuse prevention, little formal evaluation of DFW programs has been conducted. In fact, we could not identify any study in the peer-reviewed, scientific literature that systematically documented the impact of a DFW program, though many articles in trade publications provide conceptual support for the value of DFW programs. The lack of empirical understanding about the effect of DFW programs hinders the development of public policy as well as resource allocation for workplace substance abuse prevention. This article presents the findings of an evaluation from Washington State conducted to determine the impact of a publicly sponsored DFW program on the occurrence of occupational injuries. Using claims data from a workers' compensation database, we examine changes in injury rates over a seven-year period, beginning in 1994, among workers of firms enrolled in the DFW program relative to workers in non-DFW comparison firms.

Background: Rupture of the patellar tendon after total knee arthroplasty is a rare and debilitating complication. Proper surgical management of this condition remains controversial. The purpose of this study was to review the results of reconstruction of a ruptured patellar tendon with an Achilles tendon allograft following total knee arthroplasty. Methods: We reviewed our experience with the use of a fresh-frozen Achilles tendon allograft with an attached calcaneal bone graft to restore extensor function in nine patients with patellar tendon rupture following total knee arthroplasty (five primary and four revision). All patients were examined clinically and radiographically at an average of twenty-eight months. Results: The average knee and functional scores improved from 26 and 14 points, respectively, before the surgery to 81 and 53 points after the surgery. The average extensor lag decreased from 44° preoperatively to 3° postoperatively, and the average range of motion of the knee increased from 88° to 107°. Two grafts failed in the early postoperative period. Both were repaired successfully. Radiographs showed an average proximal patellar migration of 17.8 mm, which did not appear to affect extensor function. Conclusions: This short-term follow-up study showed that once an Achilles allograft has healed, it can serve as a reliable reconstruction of a ruptured patellar tendon following total knee arthroplasty. This technique may be particularly suited for patients in whom the extensor mechanism was compromised by multiple prior operations. Continued follow-up is necessary to determine the long-term durability of these results.

Background: Both shoulder surgeons and patients who are considering total shoulder arthroplasty are interested in the anticipated improvement in shoulder comfort and function after the procedure. The purpose of the present study was to characterize shoulder-specific functional gains in relation to preoperative shoulder function and to present this information in a way that can be easily communicated to patients who are considering this surgery. Methods: We analyzed the preoperative and follow-up shoulder function in patients managed with total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis. Functional self-assessments were available for 102 (80%) of 128 shoulders after thirty to sixty months of follow-up. Outcome was assessed with respect to the change in the number of shoulder functions that were performable, the change in shoulder function as a percentage of the preoperative functional deficit, and the change in the ability to perform specific shoulder functions. Results: The average number of shoulder functions that were performable improved from four of twelve preoperatively to nine of twelve postoperatively (p < 0.01). Function improved in ninety-six shoulders (94%). The number of functions that were performable at the time of follow-up was positively associated with preoperative shoulder function (p < 0.05): the better the preoperative function, the better the follow-up function. The improvement in function was greatest for shoulders with less preoperative function (p < 0.01). On the average, patients regained approximately two-thirds of the functions that had been absent preoperatively. Significant improvement was noted in eleven of the twelve shoulder functions that were examined (p < 0.01). The chance of regaining a function that had been absent before surgery was 73%, whereas the chance of losing a function that had been present before surgery was 6%. Older men tended to have greater functional improvement than younger men. Conclusion: Total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis significantly improves shoulder function. Postoperative function is related to preoperative function. The improvement that was observed in this clinical series can be conveyed to patients most simply by stating that, after surgery, shoulders typically regained approximately two-thirds of the functions that had been absent preoperatively.

Study design Prospective study. Objective This study aims to determine the psychometric properties of the modified Japanese Orthopaedic Association (mJOA) scale. Summary of background data Several outcome measures assess functional impairment and quality of life in patients with cervical myelopathy. However, a "gold standard" has not been established. One of the most widely accepted tools for assessing functional status is the mJOA scale. Methods Two hundred and seventy-seven surgical patients with cervical spondylotic myelopathy were enrolled in the prospective cervical spondylotic myelopathy-North America study. Functional status was evaluated at baseline and at 6, 12, and 24 months postoperatively. The internal consistency of the mJOA was assessed by computing a Cronbach α for the total score and after removing 1 item at a time. Convergent validity and divergent validity were measured by correlating the mJOA with other assessment tools. The responsiveness of the scale was determined by comparing mJOA scores at baseline and 12 months after surgery and computing a Cohen effect size. Results The internal consistency of the scale was moderate with a Cronbach α of 0.63. Sphincter dysfunction measured a different dimension than the other 3 scale components. The mJOA was correlated with the Nurick score (r =-0.625) but was not associated with subscales of the Short-Form 36 that measure different constructs. These findings suggest convergent and divergent validity. The mJOA was responsive to change as reflected by a Cohen effect size of 1. Conclusion The mJOA is a useful tool in the assessment of cervical spondylotic myelopathy and it should be adopted as the standard for evaluating functional status in this population.

Objectives Since 1987, the Harstad community in Norway has run an injury prevention program according to the Safe Community approach. The effectiveness of this approach in reducing injury rates is poorly documented. The aim of this study was to evaluate the impact of the Harstad program on the incidence of injuries. Methods We used data from the National Injury register of Norway and compared age-adjusted incidence rates and standardized rate ratios of injuries in Harstad and three control communities for the period 1992-1997. Results Harstad had the second highest rates for both all injuries and fractures. No reduction in the incidence of injuries in Harstad was observed from 1992-1997. The injury rates in 1992-1997 were similar to the rates recorded in 1985/86. Conclusions The injury prevention program in Harstad has not reduced overall injury rates. The Safe Community concept is an organizational strategy, but implementation of proven and targeted risk reduction measures will be needed if community-bas...

IntroductionSymptomatic metastatic epidural spinal cord compression (MESCC) afflicts up to 10% of all cancer patients. MESCC is associated with shortened survival and worsened quality of life; thus...

Background: Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition. Methods: Adultpatientswithsymptomaticcervicalspondyloticmyelopathyandmagneticresonanceimagingevidenceof spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score ‡ 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated. Results: Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups. Conclusions: Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series. Level of Evidence: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Both surgical and non-surgical treatments of geriatric Type II odontoid fractures carry a high risk of treatment failure. Surgical management of these patients is complicated by medical comorbidities, poor bone quality, and impaired physiologic reserves. Our results s uggest treatment failure in this population is associated with initial non-surgical treatment, older age, and male gender and neurologic impairment., Study Design. Multicenter prospective cohort study. Objective. To identify patient and treatment characteristics associated with treatment success or failure in the management of odontoid fractures. Summary of Background Data. Odontoid fractures are the most common cervical spine fractures in the elderly and represent a significant management challenge with widely divergent views regarding operative versus nonoperative management. Methods. A total of 159 patients 65 years and older with radiographically confirmed type II odontoid fractures were enrolled at 10 sites in the United States and 1 site in Canada between January 2006 and May 2009. Subjects were followed at 6 and 12 months post–initial treatment with Neck Disability Index and SF-36v2 scores. Final treatment outcome was classified as failure or success. Treatment failure was defined as death by any cause, decline in Neck Disability Index by more than 9.5 absolute points, or occurrence of a major treatment-related complication. Baseline characteristics between the groups were compared using t test for the continuous variables and χ2 test for the categorical variables. Baseline characteristics associated with treatment outcomes were identified by multiple logistic stepwise regression analysis. Results. A total of 101 (63.5%) patients were treated surgically and 58 (36.5%) conservatively. Forty-four (27.7%) patients had a successful outcome and 86 (54.1%) had a treatment failure; for 29 patients (18.2%), treatment status could not be determined (3 withdrew; 26 were lost to follow-up). Twenty-nine (18.2%) patients expired before the 12-month follow-up. Follow-up information was available for 103 of 127 surviving (81.1%) patients. Twelve-month SF-36v2 scores were worse in the failure group. The characteristics associated with treatment failure were older age (odds ratio [OR] = 1.08 for each year of age); initial nonsurgical treatment (OR = 3.09); male sex (OR = 4.33), and baseline neurological system comorbidity (OR = 4.13). Conclusion. Older age, initial nonsurgical treatment, and male sex are associated with failure of treatment in patients with geriatric odontoid fractures.

The objective of this study is to determine the incidence and risk factors of postoperative dysphagia and to evaluate short- and long-term clinical outcomes in patients with this complication. Four hundred seventy patients undergoing an anterior or a 2-stage surgery were enrolled in the prospective AOSpine CSM-North America or International study at 26 global sites. Logistic regression analyses were conducted to determine important clinical and surgical predictors of dysphagia. Preoperatively and at each follow-up, patients were evaluated using the modified Japanese Orthopedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and the SF-36. A mixed model analytic approach was used to evaluate differences in outcomes at 6 and 24 months between patients with and without dysphagia, while controlling for relevant baseline characteristics and surgical factors. The overall incidence of dysphagia was 6.17%. Univariately, the major risk factors for perioperative dysphagia were a higher comorbidity score (odds ratio [OR]: 1.289, P = .002), the presence of cardiovascular (OR: 2.584, P = .016) and endocrine (OR: 4.234, P = .001) disorders, a 2-stage surgery (OR (ref = 1-stage): 6.506, P = .0003) and a greater number of decompressed levels (OR: 1.816, P = .002). Based on multivariate analysis, patients were at an increased risk of perioperative dysphagia if they had diabetes mellitus (OR (ref = absence): 3.686, P = .001), a greater number of decompressed segments (OR: 1.522, P = .049), and a 2-stage surgery (OR (ref = 1-stage): 3.423, P = .037). Clinical improvements, as evaluated by the Nurick and mJOA, were comparable between patients with and without dysphagia at both short- and long-term follow-up. In contrast, patients with dysphagia had significantly worse scores on the NDI at 6 months postoperatively than patients without dysphagia; however, at 24 months postoperatively, there were no differences between groups. The most important predictors of dysphagia are diabetes mellitus, a greater number of decompressed levels, and a 2-stage surgery. Patients with postoperative dysphagia have reduced disability and quality-of-life improvements in the short term but not in the long term.