200 results on '"de Kleuver, Marinus"'
Search Results
152. Evolution and Advancement of Adult Spinal Deformity Research and Clinical Care: An Overview of the Scoli-RISK-1 Study.
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Cerpa, Meghan, Lenke, Lawrence G., Fehlings, Michael G., Shaffrey, Christopher I., Cheung, Kenneth M. C., Carreon, Leah Yacat, Samartzis, Dino, Germscheid, Niccole M., Fisher, Charles G., de Kleuver, Marinus, Öner, F. Cumhur, Yoon, S. Tim, and Vialle, Luiz R.
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- 2019
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153. Short-Term Results Of Fusionless Scoliosis Correction: A Prospective Cohort Study.
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Holewijn, Roderick M., Haanstra, Tsjitske, Faraj, Sayf S. A., de Kleuver, Marinus, and Stadhouder, Agnita
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- 2018
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154. Triple osteotomy of the pelvis--an anatomical, biomechanical and clinical study.
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de Kleuver, Marinus
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OSTEOTOMY , *PELVIS , *ACADEMIC dissertations - Abstract
Discusses the abstract of the dissertation 'Triple osteotomy of the pelvis-an anatomical, biomechanical and clinical study,' by Marinus de Kleuver published in the December 1999 issue of the 'Acta Orthopaedica Scandinavica' journal.
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- 1999
155. Adolescent idiopathic scoliosis: spinal fusion and beyond
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Holewijn, R.M., de Kleuver, Marinus, van Royen, Barend, Kingma, I., Keijsers, N.L.W., Orthopaedic Surgery, Amsterdam Movement Sciences - Restoration and Development, de Kleuver, M., and van Royen, B.J.
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Spinal surgery ,Gait ,Adolescent idiopathic scoliosis - Published
- 2019
156. Towards a paradigm shift in chronic low back pain?: Identification of patient profiles to guide treatment
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van Hooff, ML, de Kleuver, M., Ostelo, RWJG, Spruit, M., de Kleuver, Marinus, Ostelo, Raymond, Spruit, Maarten, and Orthopaedic Surgery
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low back pain ,spine ,prediction ,disability ,surgery ,pain management ,outcome ,decision tool ,validity ,quality ,registry ,success ,response ,patient-reported outcomes ,prognostic ,patient profiles ,functioning - Published
- 2017
157. International consensus-based ranking of definitions for poor response to primary total knee arthroplasty: a Delphi study.
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Te Molder MEM, van Onsem S, Smolders JMH, Dowsey MM, Rolfson O, Singh JA, de Kleuver M, Heesterbeek PJC, and van den Ende CHM
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- Humans, Female, Male, Arthroplasty, Replacement, Knee, Delphi Technique, Consensus
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Introduction: This study aimed to rank definitions for measuring poor response one year after TKA, after assessing the face validity and feasibility of existing or newly proposed definitions., Materials and Methods: An international, three-round, online modified Delphi study was conducted with sixty-nine panelists from twenty-three countries. Definitions were derived from a literature review or were newly proposed by an expert group. Panelists rated the face validity and feasibility of definitions, and could propose additional new definitions in round 1. Panelists reconsidered their rating of existing definitions, and rated newly suggested definitions (round 2). Definitions with a median score for face validity < 6.5 were removed from the list, and panelists distributed 100 points among the remaining definitions for ranking (round 3)., Results: Fifty-one panelists completed all three rounds (response rate 74%), and the prioritized list of definitions in round 3 comprised seventeen definitions. The single-item definition of (dis)satisfaction with the outcome of TKA obtained the highest scores for face validity and feasibility (7.5, and 8.5 respectively), and the definition "No improvement in pain OR daily knee functioning compared to pre-operative status" was the highest prioritized. In general, definitions reflecting change from the perception of patients were higher ranked than definitions requiring both preoperative and postoperative assessment of validated questionnaires., Conclusions: This study identified seventeen potential definitions of poor response to TKA, offering valuable options for integration into quality assessment investigations. Remarkably, all identified definitions were patient-centered and none were clinician-centered. Single-item questions, capturing change from the patient's viewpoint, appear to be the most practicable format to assess response., Competing Interests: Declarations. Competing interests: The authors have no competing interests to declare that are relevant to the content of this article., (© 2024. The Author(s).)
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- 2024
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158. Independent Prognostic Factors Associated With Improved Patient-Reported Outcomes in the Prospective Evaluation of Elderly Deformity Surgery (PEEDS) Study.
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Hassan FM, Lenke LG, Berven SH, Kelly MP, Smith JS, Shaffrey CI, Dahl BT, de Kleuver M, Spruit M, Pellise F, Cheung KMC, Alanay A, Polly DW Jr, Sembrano J, Matsuyama Y, Qiu Y, and Lewis SJ
- Abstract
Study Design: Prospective, multicenter, international, observational study., Objective: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery., Methods: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively., Results: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) - OR: .01 [.00-.12]; (2)- OR: .00 [.00-.07]) and number of severe adverse events (AEs) ((1) - OR: .48 [.28-.82]; (2)- OR: .39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) - OR: 1.05 [1.02-1.07]) and number of severe AEs (OR: .58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR: .44 [.25-.77]) and baseline PROMs (OR: .01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR: .50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches., Conclusion: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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159. Development of the scoliosis research society spinal deformity surgery safety checklist.
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De la Garza Ramos R, Scheer JK, Matmati N, Hey LA, Burton DC, de Kleuver M, Ames CP, and Yanamadala V
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Purpose: Spine deformity surgery is a complex multi-step procedure that has a relatively high complication rate. The use of surgical safety checklists has been shown to reduce perioperative adverse events, but existing lists are varied and non-specific for spinal deformity surgery. Thus, the purpose of this study was to develop a comprehensive surgical checklist for complex spinal corrective surgery., Methods: An electronic survey consisting of 187 surgical checklist items that had been developed and used by a group of SRS members over a 5-year period was distributed to the Scoliosis Research Society Safety and Value Committee membership. The survey sections included: (1) pre-operative area, (2) initial operating room visit, (3) before turning, (4) positioning, (5) prepare and drape, (6) pre-incision timeout, (7) intraoperative, (8) finishing implant placement and confirming imaging, (9) final rods and locking, (10) prior to closure, (11) closure, (12) turn to supine, and (13) checkout/debriefing. Respondents graded each item on a five-point Likert scale based on their perceived importance and feasibility for inclusion in the checklist. Features graded as "moderately important" or "very important" to include by at least 70% of respondents were considered to meet the cutoff for inclusion-based standard Delphi practices. Study data were collated using REDCap., Results: A total of 25 surgeons completed the survey in its entirety. The overall checklist "package" was shortened to 9 individual checklist modules, with 2 to 16 items per checklist. In terms of individual checklist items, 40% of items (74 of 187) met the cutoff for inclusion; 17 of these items were graded as "very important," which included verifying the presence of implantable devices, reviewing the surgical plan and positioning with the surgical staff, securing the endotracheal tube, bite block confirmation, prone and lateral positioning, neuromonitoring baseline readings, double-checking that the implant screw caps were locked prior to closure, and confirming that the patient was moving bilateral lower extremities before leaving the operating room when possible., Conclusion: This study has led to the development of a specific spinal deformity surgical checklist of 74 (many specific to spine surgery) items that were considered important for inclusion; 17 were considered "very important"., (© 2024. The Author(s).)
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- 2024
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160. AI-based lumbar central canal stenosis classification on sagittal MR images is comparable to experienced radiologists using axial images.
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van der Graaf JW, Brundel L, van Hooff ML, de Kleuver M, Lessmann N, Maresch BJ, Vestering MM, Spermon J, van Ginneken B, and Rutten MJCM
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Objectives: The assessment of lumbar central canal stenosis (LCCS) is crucial for diagnosing and planning treatment for patients with low back pain and neurogenic pain. However, manual assessment methods are time-consuming, variable, and require axial MRIs. The aim of this study is to develop and validate an AI-based model that automatically classifies LCCS using sagittal T2-weighted MRIs., Methods: A pre-existing 3D AI algorithm was utilized to segment the spinal canal and intervertebral discs (IVDs), enabling quantitative measurements at each IVD level. Four musculoskeletal radiologists graded 683 IVD levels from 186 LCCS patients using the 4-class Lee grading system. A second consensus reading was conducted by readers 1 and 2, which, along with automatic measurements, formed the training dataset for a multiclass (grade 0-3) and binary (grade 0-1 vs. 2-3) random forest classifier with tenfold cross-validation., Results: The multiclass model achieved a Cohen's weighted kappa of 0.86 (95% CI: 0.82-0.90), comparable to readers 3 and 4 with 0.85 (95% CI: 0.80-0.89) and 0.73 (95% CI: 0.68-0.79) respectively. The binary model demonstrated an AUC of 0.98 (95% CI: 0.97-0.99), sensitivity of 93% (95% CI: 91-96%), and specificity of 91% (95% CI: 87-95%). In comparison, readers 3 and 4 achieved a specificity of 98 and 99% and sensitivity of 74 and 54%, respectively., Conclusion: Both the multiclass and binary models, while only using sagittal MR images, perform on par with experienced radiologists who also had access to axial sequences. This underscores the potential of this novel algorithm in enhancing diagnostic accuracy and efficiency in medical imaging., Key Points: Question How can the classification of lumbar central canal stenosis (LCCS) be made more efficient? Findings Multiclass and binary AI models, using only sagittal MR images, performed on par with experienced radiologists who also had access to axial sequences. Clinical relevance Our AI algorithm accurately classifies LCCS from sagittal MRI, matching experienced radiologists. This study offers a promising tool for automated LCCS assessment from sagittal T2 MRI, potentially reducing the reliance on additional axial imaging., (© 2024. The Author(s).)
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- 2024
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161. Development and validation of AI-based automatic measurement of coronal Cobb angles in degenerative scoliosis using sagittal lumbar MRI.
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van der Graaf JW, van Hooff ML, van Ginneken B, Huisman M, Rutten M, Lamers D, Lessmann N, and de Kleuver M
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- Humans, Female, Male, Reproducibility of Results, Retrospective Studies, Aged, Middle Aged, Aged, 80 and over, Artificial Intelligence, Adult, Imaging, Three-Dimensional methods, Scoliosis diagnostic imaging, Magnetic Resonance Imaging methods, Lumbar Vertebrae diagnostic imaging, Algorithms
- Abstract
Objectives: Severity of degenerative scoliosis (DS) is assessed by measuring the Cobb angle on anteroposterior radiographs. However, MRI images are often available to study the degenerative spine. This retrospective study aims to develop and evaluate the reliability of a novel automatic method that measures coronal Cobb angles on lumbar MRI in DS patients., Materials and Methods: Vertebrae and intervertebral discs were automatically segmented using a 3D AI algorithm, trained on 447 lumbar MRI series. The segmentations were used to calculate all possible angles between the vertebral endplates, with the largest being the Cobb angle. The results were validated with 50 high-resolution sagittal lumbar MRI scans of DS patients, in which three experienced readers measured the Cobb angle. Reliability was determined using the intraclass correlation coefficient (ICC)., Results: The ICCs between the readers ranged from 0.90 (95% CI 0.83-0.94) to 0.93 (95% CI 0.88-0.96). The ICC between the maximum angle found by the algorithm and the average manually measured Cobb angles was 0.83 (95% CI 0.71-0.90). In 9 out of the 50 cases (18%), all readers agreed on both vertebral levels for Cobb angle measurement. When using the algorithm to extract the angles at the vertebral levels chosen by the readers, the ICCs ranged from 0.92 (95% CI 0.87-0.96) to 0.97 (95% CI 0.94-0.98)., Conclusion: The Cobb angle can be accurately measured on MRI using the newly developed algorithm in patients with DS. The readers failed to consistently choose the same vertebral level for Cobb angle measurement, whereas the automatic approach ensures the maximum angle is consistently measured., Clinical Relevance Statement: Our AI-based algorithm offers reliable Cobb angle measurement on routine MRI for degenerative scoliosis patients, potentially reducing the reliance on conventional radiographs, ensuring consistent assessments, and therefore improving patient care., Key Points: • While often available, MRI images are rarely utilized to determine the severity of degenerative scoliosis. • The presented MRI Cobb angle algorithm is more reliable than humans in patients with degenerative scoliosis. • Radiographic imaging for Cobb angle measurements is mitigated when lumbar MRI images are available., (© 2024. The Author(s).)
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- 2024
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162. The Influence of Multilevel Spinal Deformity Surgery on the EuroQol 5 Dimensions' (EQ-5D) Questionnaire and Residential Status in the Elderly: A Prospective, Observational, Multicenter Study.
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Jentzsch T, Lewis SJ, Oitment C, Rienmüller A, Martin AR, Nielsen CJ, Shear-Yashuv H, de Kleuver M, Qiu Y, Matsuyama Y, Lenke LG, Alanay A, Pellisé-Urquiza F, Cheung KMC, Spruit M, Polly DW, Sembrano JN, Shaffrey CI, Smith JS, Kelly MP, Dahl B, and Berven SH
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Study Design: Multicenter, international prospective study., Objective: This study investigated the clinical outcome up to 2 years after multi-level spinal deformity surgery in the elderly by reporting the minimal clinically important difference (MCID) of EuroQol 5-dimensions (EQ-5D), EQ-VAS, and residential status., Methods: As an ancillary study of 219 patients ≥60 years with spinal deformity undergoing primary instrumented fusion surgery of ≥5 levels, this study focuses on EQ-5D (3-L) as the primary outcome and EQ-VAS and residential status as secondary outcomes. Data on EQ-5D were compared between pre-operatively and postoperatively at 10 weeks, 12 months, and 24 months. An anchor-based approach was used to calculate the MCID., Results: The EQ-5D index and EQ-VAS, respectively, improved significantly at each time point compared to pre-operatively (from .53 (SD .21) and 55.6 (SD 23.0) pre-operatively to .64 (SD .18) and 65.8 (SD 18.7) at 10 weeks, .74 (SD .18) and 72.7 (SD 18.1) at 12 months, and .73 (SD .20) and 70.4 (SD 20.4) at 24 months). 217 (99.1%) patients lived at home pre-operatively, while 186 (88.6%), 184 (98.4%), and 172 (100%) did so at 10 weeks, 12 months, and 24 months, respectively. Our calculated MCID for the EQ-5D index at 1 year was .22 (95% CI .15-.29)., Conclusions: The EQ-5D index significantly increased at each time point over 24 months after ≥5 level spinal deformity surgery in elderly patients. The MCID of the EQ-5D-3 L was .22. Patients living at home pre-operatively can expect to be able to live at home 2 years postoperatively., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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163. The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.
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Baetsen JTF, Hooff ML, Bisseling P, Van Dongen JM, Van de Fliert DG, Hoebink E, Kempen DHR, Rutges JPHJ, Schlösser TPC, Van West HM, Van der Wees PJ, Willems PC, and De Kleuver M
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- Adolescent, Child, Female, Humans, Male, Follow-Up Studies, Randomized Controlled Trials as Topic, Radiography economics, Scoliosis diagnostic imaging
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Background and Purpose: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences., Methods and Analyses: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.
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- 2024
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164. Lumbar spine segmentation in MR images: a dataset and a public benchmark.
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van der Graaf JW, van Hooff ML, Buckens CFM, Rutten M, van Susante JLC, Kroeze RJ, de Kleuver M, van Ginneken B, and Lessmann N
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- Humans, Algorithms, Image Processing, Computer-Assisted methods, Magnetic Resonance Imaging methods, Low Back Pain, Intervertebral Disc pathology, Lumbar Vertebrae diagnostic imaging
- Abstract
This paper presents a large publicly available multi-center lumbar spine magnetic resonance imaging (MRI) dataset with reference segmentations of vertebrae, intervertebral discs (IVDs), and spinal canal. The dataset includes 447 sagittal T1 and T2 MRI series from 218 patients with a history of low back pain and was collected from four different hospitals. An iterative data annotation approach was used by training a segmentation algorithm on a small part of the dataset, enabling semi-automatic segmentation of the remaining images. The algorithm provided an initial segmentation, which was subsequently reviewed, manually corrected, and added to the training data. We provide reference performance values for this baseline algorithm and nnU-Net, which performed comparably. Performance values were computed on a sequestered set of 39 studies with 97 series, which were additionally used to set up a continuous segmentation challenge that allows for a fair comparison of different segmentation algorithms. This study may encourage wider collaboration in the field of spine segmentation and improve the diagnostic value of lumbar spine MRI., (© 2024. The Author(s).)
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- 2024
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165. The Dutch version of the Spinal Appearance Questionnaire for adolescents with idiopathic scoliosis: patient-based cross-cultural adaptation and measurement properties evaluation.
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van de Fliert DG, Schlösser TPC, Kempen DHR, Rutges JPHJ, Bisseling P, de Kleuver M, and van Hooff ML
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- Humans, Male, Adolescent, Female, Cross-Cultural Comparison, Reproducibility of Results, Psychometrics, Surveys and Questionnaires, Scoliosis diagnosis
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Purpose: Adolescent idiopathic scoliosis (AIS) affects the appearance of spine and trunk. The Spinal Appearance Questionnaire (SAQ) assesses the perception of appearance in AIS patients. The aim of this study is to translate and culturally adapt the recommended short version of the SAQ into Dutch and to test its measurement properties., Methods: A Dutch SAQ (14-item; appearance and expectations domains) was developed following guidelines for translation and cross-cultural adaptation. The COSMIN Study Design checklist was used for measurement properties evaluation. In this multicenter study, the Dutch SAQ, SRS-22R and NPRS (back pain) were administered to 113 AIS patients (aged 15.4 years [SD 2.2], 21.2% male). Floor and ceiling effects were evaluated for content analysis. For reliability, internal consistency (Cronbach's alpha) and test-retest reliability (ICC; n = 34) were evaluated. Predefined hypotheses of relationships with other questionnaires and between subgroups based on scoliosis severity (radiological and clinical) were tested for construct validity. Exploratory factor analysis (EFA) was performed to investigate the validity of the underlying structure of this 14-item questionnaire., Results: No floor and ceiling effects were found for domains and total scores. Cronbach's alpha ranged from 0.84 to 0.89. ICCs varied from 0.76 to 0.77. For construct validity, 89% (8/9) of the predefined hypotheses were confirmed. Significant higher scores for the appearance domain were found for subgroups based on radiological (Cobb angle; > 25.0°) and clinical outcomes. (Angle of Trunk Rotation; > 9.0°). A two-factor structure was found (EV 5.13; 36.63% explained variance)., Conclusion: The Dutch SAQ is an adequate, valid and reliable instrument to evaluate patients' perception of appearance in AIS., Level of Evidence: Level I-diagnostic studies., (© 2023. The Author(s).)
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- 2024
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166. Clinical and radiological assessment of scoliosis in Koolen-de Vries syndrome.
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Bouman A, Bouwmeester RN, van Vlimmeren LA, Burger P, Mandel JL, de Vries BBA, de Kleuver M, Klein WM, Geelen JM, and Koolen DA
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- Humans, Infant, Child, Preschool, Child, Adolescent, Young Adult, Adult, Retrospective Studies, Intellectual Disability diagnostic imaging, Intellectual Disability epidemiology, Scoliosis diagnostic imaging, Scoliosis epidemiology, Abnormalities, Multiple diagnosis
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The Koolen-de Vries syndrome (KdVS) is a multisystem disorder characterized by developmental delay, intellectual disability, characteristic facial features, epilepsy, cardiovascular and urogenital malformations, and various musculoskeletal disorders. Scoliosis is a common feature. The aim of this study is to fill the gap in the current knowledge about scoliosis in individuals with KdVS and to provide recommendations for management and follow-up. In total, 54 individuals with KdVS were included in the study, with a mean age of 13.6 years (range 1.9-38.8 years). Spine radiographs, MR scans, and corresponding radiology reports were analyzed retrospectively for scoliosis and additional anomalies. The presence of scoliosis-related clinical conditions was assessed in participants' medical records and by use of a parent survey. Scoliosis was present in 56% of the participants (30/54) with a mean age of onset of 10.6 years and curve progression during the growth spurt. Prevalence at age 6, 10, and 18 years was, respectively, 9%, 41%, and 65%. Most participants were diagnosed with a single curve (13/24, 54%), of which five participants had a long C-curve type scoliosis. No significant risk factors for development of scoliosis could be identified. Severity was mostly classified as mild, although 29% (7/24) of the curves were larger than 30° at last follow-up. Bracing therapy was received in 13% (7/54), and surgical spinal fusion was warranted in 6% (3/54). Remarkably, participants with scoliosis received less often physical therapy compared to participants without scoliosis (P = 0.002). Scoliosis in individuals with KdVS should be closely monitored and radiologic screening for scoliosis and vertebrae abnormalities is recommended at diagnosis of KdVS, and the age of 10 and 18 years., (© 2023 The Authors. American Journal of Medical Genetics Part A published by Wiley Periodicals LLC.)
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- 2023
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167. Have Surgery and Implant Modifications Been Associated With Reduction in Soft Tissue Complications in Transfemoral Bone-anchored Prostheses?
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Atallah R, Reetz D, Verdonschot N, de Kleuver M, Frölke JPM, and Leijendekkers RA
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- Humans, Osseointegration, Surgical Wound Infection, Titanium, Prosthesis Design, Treatment Outcome, Bone-Anchored Prosthesis, Periprosthetic Fractures, Soft Tissue Infections
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Background: The most frequently occurring adverse events in individuals with a transfemoral amputation treated with a bone-anchored prosthesis are soft tissue infections and stoma-related complications. These soft tissue complications are believed to be influenced by surgical technique and implant design, but little is known about the effect of changes to treatment on these events., Questions/purposes: (1) What is the result of surgical technique and implant modifications on the incidence of soft tissue infections and stoma-related complications in transfemoral bone-anchored prosthesis users, depending on whether they had a conventional stoma and a cobalt-chrome-molybdenum (CoCrMo) osseointegration implant (treatment period 2009 to 2013) or a shallower stoma and titanium osseointegration implant (2015 to 2018)? (2) What is the incidence of serious complications, such as bone or implant infection, aseptic loosening, intramedullary stem breakage, and periprosthetic fracture?, Methods: Between 2009 and 2013, we performed osseointegration implant surgery using a conventional surgical technique and a CoCrMo implant in 42 individuals who had a lower extremity amputation experiencing socket-related problems that resulted in limited prosthesis use. We considered all individuals treated with two-stage surgery with a standard press-fit transfemoral osseointegration implant as potentially eligible for inclusion. Based on this, 100% (42) were eligible, and 5% (two of 42) were excluded because they did not provide informed consent, leaving 95% (40 of 42) for analysis. Between 2015 and 2018, we treated 79 individuals with similar indications with osseointegration implant surgery, now also treating individuals with dysvascular amputations. We used an adapted surgical technique resulting in a shallower stoma combined with a titanium implant. Using the same eligibility criteria as for the first group, 51% (40 of 79) were eligible; 49% (39 of 79) were excluded because they were treated with transtibial amputation, a patient-specific implant, or single-stage surgery and 1% (one of 79) were lost before the 2-year follow-up interval, leaving 49% (39 of 79) for analysis. The period of 2013 to 2015 was a transitional period and was excluded from analysis in this study to keep groups reasonably comparable and to compare a historical approach with the present approach. Hence, we presented a comparative study of two study groups (defined by surgical technique and implant design) with standardized 2-year follow-up. The risk factors for adverse events were similar between groups, although individuals treated with the shallow stoma surgical technique and titanium implant potentially possessed an increased risk because of the inclusion of individuals with dysvascular amputation and the discontinuation of prolonged postoperative antibiotic prophylaxis. Outcomes studied were soft tissue infections and stoma-related complications (hypergranulation or keloid formation as well as stoma redundant tissue) and bone or implant infection, aseptic loosening, implant stem breakage, periprosthetic fracture, and death., Results: Patients treated with the shallow stoma surgical technique and titanium implant experienced fewer soft tissue infections (13 versus 76 events, absolute risk 0.17 [95% CI 0.09 to 0.30] versus 0.93 [95% CI 0.60 to 1.45]; p < 0.01), which were treated with less invasive measures, and fewer stoma redundant tissue events (0 versus five events, absolute risk 0 versus 0.06 [95% CI 0.03 to 0.14]) than patients treated with the conventional stoma surgical technique and CoCrMo implant. This was contrasted by an increased incidence of surgical site infections occurring between surgical stages 1 and 2, when no stoma was yet created, after the implementation of treatment changes (conventional surgery and CoCrMo implant versus shallow stoma surgery and titanium implant: one versus 11 events, absolute risk 0.01 [95% CI 0.00 to 0.08] versus 0.14 [95% CI 0.08 to 0.25]; p = 0.02). Patients treated with the shallow stoma surgical technique and titanium implant did not experience serious complications, although bone infections occurred (six events in 8% [three of 40] of patients) in the conventional surgery and CoCrMo implant group, all of which were successfully treated with implant retention., Conclusion: Adaptations to surgical technique and newer implant designs, as well as learning curve and experience, have resulted in a reduced incidence and severity of soft tissue infections and stoma redundant tissue, contrasted by an increase in surgical site infections before stoma creation. Serious complications such as deep implant infection were infrequent in this 2-year follow-up period. We believe the benefits of these treatment modifications outweigh the disadvantages and currently advise surgeons to create a shallower stoma with a stable soft tissue envelope, combined with a titanium implant., Level of Evidence: Level III, therapeutic study., Competing Interests: Each author certifies that there are no funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article related to the author or any immediate family members. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request., (Copyright © 2023 by the Association of Bone and Joint Surgeons.)
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- 2023
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168. Spinal deformity surgery is accompanied by serious complications: report from the Morbidity and Mortality Database of the Scoliosis Research Society from 2013 to 2020.
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Bivona LJ, France J, Daly-Seiler CS, Burton DC, Dolan LA, Seale JJ, de Kleuver M, Ferrero E, Gurd DP, Konya D, Lavelle WF, Sarwahi V, Suratwala SJ, Yilgor C, and Li Y
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- Humans, Retrospective Studies, Postoperative Complications epidemiology, Morbidity, Societies, Medical, Vision Disorders, Blindness, Scoliosis surgery, Spondylolisthesis, Kyphosis, Neuromuscular Diseases
- Abstract
Purpose: The Morbidity and Mortality (M&M) report of the Scoliosis Research Society (SRS) has been collected since 1965 and since 1968 submission of complications has been required of all members. Since 2009, the SRS has collected information on death, blindness, and neurological deficit, with acute infection being added in 2012 and unintentional return to the operating room (OR) being added in 2017. In this report, we use the most recent data submitted to the SRS M&M database to determine the rate of neurological deficit, blindness, acute infection, unintentional return to the OR, and death, while also comparing this information to previous reports., Methods: The SRS M&M database was queried for all cases from 2013 to 2020. The rates of death, vision loss, neurological deficit, acute infection, and unintentional return to the OR were then calculated and analyzed. The rates were compared to previously published data if available. Differences in complication rates between years were analyzed with Poisson regression with significance set at α = 0.05., Results: The total number of cases submitted per year varied with a maximum of 49,615 in 2018 and a minimum of 40,464 in 2020. The overall reported complication rate from 2013 to 2020 was 2.86%. The overall mortality rate ranged from 0.09% in 2018 to 0.14% in 2015. The number of patients with visual impairment ranged from 4 to 13 between 2013 and 2015 (no data on visual impairment were collected after 2015). The overall infection rate varied from 0.95 in 2020 to 1.30% in 2015. When the infection rate was analyzed based on spinal deformity group, the neuromuscular scoliosis group consistently had the highest infection rate ranging from 3.24 to 3.94%. The overall neurological deficit rate ranged from 0.74 to 0.94%, with the congenital kyphosis and dysplastic spondylolisthesis groups having the highest rates. The rates of unintentional return to the OR ranged from 1.60 to 1.79%. Multiple groups showed a statistically significant decreasing trend for infection, return to the operating room, neurologic deficit, and death., Conclusions: Neuromuscular scoliosis had the highest infection rate among all spinal deformity groups. Congenital kyphosis and dysplastic spondylolisthesis had the highest rate of neurological deficit postoperatively. This is similar to previously published data. Contrary to previous reports, neuromuscular scoliosis did not have the highest annual death rate. Multiple groups showed a statistically significant decreasing trend in complication rates during the reporting period, with only mortality in degenerative spondylolisthesis significantly trending upwards., Level of Evidence: Level III., (© 2022. The Author(s).)
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- 2022
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169. Pulmonary symptoms in adolescent idiopathic scoliosis: a systematic review to identify patient-reported and clinical measurement instruments.
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Te Hennepe N, Faraj SSA, Pouw MH, de Kleuver M, and van Hooff ML
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- Adolescent, Humans, Patient Reported Outcome Measures, Quality of Life, Reproducibility of Results, Kyphosis, Scoliosis diagnosis
- Abstract
Study Design: Systematic review., Purpose: Adolescent idiopathic scoliosis (AIS) is a deformity of the trunk and chest and can cause a spectrum of pulmonary symptoms. However, no standardized measurement instrument exists. The aim of this systematic review is to identify and describe patient-reported and clinical measurement instruments used to evaluate pulmonary symptoms in patients with AIS., Methods: Studies published after 01.01.2000 were included in a systematic search. Patient-reported outcome measures (PROMs) and clinical measurement instruments for pulmonary symptoms were extracted as well as their measurement properties (floor-ceiling effects, validity, reliability, responsivity and interpretability). The Risk of Bias (RoB) was evaluated., Results: Out of 3146 studies, 122 were eligible for inclusion. Seven clinical measurement instruments, measuring 50 measurement parameters, were identified. Five PROMs for pulmonary symptoms were identified. Studies assessing the quality of measurement properties in the AIS population were not identified. As such, the RoB could not be determined., Conclusion: No available adequate patent centric instruments were identified that measure pulmonary functioning and symptoms. Although clinical measurement instruments are regularly used, their use in routine practice does not seem feasible. The measurement properties of some identified PROMs seem promising; however, they have not been validated in an AIS population. As pulmonary symptoms in patients with AIS are still poorly understood, the development of such a construct and potentially a subsequent PROM to routinely measure pulmonary functioning and patient experience is recommended., (© 2022. The Author(s).)
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- 2022
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170. Which frailty scales for patients with adult spinal deformity are feasible and adequate? A systematic review.
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Kitamura K, van Hooff M, Jacobs W, Watanabe K, and de Kleuver M
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- Aged, Frail Elderly, Humans, Postoperative Complications epidemiology, Prospective Studies, Risk Assessment, Treatment Outcome, Frailty complications, Frailty diagnosis, Frailty epidemiology, Spinal Diseases surgery
- Abstract
Background Context: Frailty as a concept is not yet fully understood, and is not the same as comorbidity. It is associated with an increased risk of adverse events and mortality after surgery, which makes its preoperative assessment significant. Despite its relevance, it still remains unclear which scales are appropriate for use in patients with spinal pathology., Purpose: To evaluate the feasibility and measurement properties of frailty scales for spine patients, specifically with adult spinal deformity (ASD), and to propose adequate scales for primary triage to prevent surgery in too frail patients and for preoperative assessment to modify patients' condition and surgical plans., Study Design/setting: Systematic review., Methods: Systematic search was performed between 2010 and 2021 including terms relating to spinal disorders, frailty scales, and methodological quality. Characteristics of the studies and frailty scales and data describing relation to treatment outcomes were extracted. The risk of bias was determined with the QAREL score., Results: Of the 1993 references found, 88 original studies were included and 23 scales were identified. No prospective interventional study was found where the preoperative frailty assessment was implemented. Predictive value of scales for surgical outcomes varied, dependent on spinal disorders, type of surgeries, patients' age and frailty at baseline, and outcomes. Seventeen studies reported measurement properties of eight scales but these studies were not free of bias. In 30 ASD studies, ASD-Frailty Index (ASD-FI, n=14) and 11-item modified Frailty Index (mFI-11, n=11) were most frequently used. These scales were mainly studied in registry studies including young adult population, and carry a risk of sample bias and make their validity in elderly population unclear. ASD-FI covers multidisciplinary concepts of frailty with 40 items but its feasibility in clinical practice is questionable due to its length. The Risk Analysis Index, another multidisciplinary scale with 14 items, has been implemented for preoperative assessment in other surgical domains and was proven to be feasible and effective in interventional prospective studies. The FRAIL is a simple questionnaire with five items and its predictive value was confirmed in prospective cohort studies in which only elderly patients were included., Conclusions: No adequate scale was identified in terms of methodological quality and feasibility for daily practice. Careful attention should be paid when choosing an adequate scale, which depends on the setting of interest (eg triage or preoperative work-up). We recommend to further study a simple and predictive scale such as FRAIL for primary triage and a comprehensive and feasible scale such as Risk Analysis Index for preoperative assessment for patients undergoing spine surgery, as their adequacy has been shown in other medical domains., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2022
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171. Health Care Professional Mental Health and Supporting the Second Victim - Can Organizations Across the World Do Better?
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Kuris EO, de Kleuver M, Alsoof D, McDonald CL, and Daniels AH
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- Humans, Medical Errors, Health Personnel psychology, Mental Health
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- 2022
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172. Relevant impact of surgery on quality of life for adolescent idiopathic scoliosis : a registry-based two-year follow-up cohort study.
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Mens RH, Bisseling P, de Kleuver M, and van Hooff ML
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- Adolescent, Female, Follow-Up Studies, Humans, Male, Musculoskeletal Pain etiology, Recovery of Function, Registries, Retrospective Studies, Scoliosis complications, Scoliosis psychology, Self Concept, Treatment Outcome, Patient Reported Outcome Measures, Quality of Life psychology, Scoliosis surgery, Spinal Fusion psychology
- Abstract
Aims: To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set., Methods: AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman's analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index)., Results: At baseline, 65 out of 144 patients (45%) reported numerical rating scale (NRS) back pain scores > 5. All PROMs significantly improved at two-year follow-up. Mean improvements in SRS-22r function (+ 1.2 (SD 0.6)), pain (+ 0.6 (SD 0.8)), and self-image (+ 1.1 (SD 0.7)) domain scores, and the SRS-22r total score (+ 0.5 (SD 0.5)), were clinically relevant. At two-year follow-up, 14 out of 144 patients (10%) reported NRS back pain > 5. Surgical site infections did not occur. Only one patient (0.7%) underwent revision surgery., Conclusion: Relevant improvement in functioning, condition-specific and health-related QoL, self-image, and a relevant decrease in pain is shown at two-year follow-up after fusion surgery for AIS, with few adverse events. Contrary to the general perception that AIS is a largely asymptomatic condition, nearly half of patients report significant preoperative back pain, which reduced to 10% at two-year follow-up. Cite this article: Bone Joint J 2022;104-B(2):265-273.
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- 2022
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173. Stratifying outcome based on the Oswestry Disability Index for operative treatment of adult spinal deformity on patients 60 years of age or older: a multicenter, multi-continental study on Prospective Evaluation of Elderly Deformity Surgery (PEEDS).
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Nielsen CJ, Lewis SJ, Oitment C, Martin AR, Lenke LG, Qiu Y, Cheung KM, de Kleuver M, Polly DW, Shaffrey CI, Smith JS, Spruit M, Alanay A, Matsuyama Y, Jentzsch T, Rienmuller A, Shear-Yashuv H, Pellisé F, Kelly MP, Sembrano JN, Dahl BT, Berven SH, and Forum Deformity ASK
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- Adult, Aged, Child, Preschool, Humans, Infant, Longitudinal Studies, Quality of Life, Retrospective Studies, Spine, Treatment Outcome, Disability Evaluation, Scoliosis
- Abstract
Background Context: Patients with adult spinal deformity suffer from disease related disability as measured by the Oswestry Disability Index (ODI) for which surgery can result in significant improvements., Purpose: The purpose of this study was to show the change in overall and individual components of the ODI in patients aged 60 years or older following multi-level spinal deformity surgery., Study Design: Prospective, multicenter, multi-continental, observational longitudinal cohort study PATIENT SAMPLE: Patients ≥60 years undergoing primary spinal fusion surgery of ≥5 levels for coronal, sagittal or combined deformity., Outcome Measures: Oswestry Disability Index (ODI) METHODS: : Patients completed the ODI pre-operatively for baseline, then at 10 weeks, 12 months and 24 months post-operatively. ODI scores were grouped into deciles, and change was calculated with numerical score and improvement or worsening was further categorized from baseline as substantial (≥20%), marginal (≥10-<20%) or no change (within 10%)., Results: Two-hundred nineteen patients met inclusion criteria for the study. The median number of spinal levels fused was 9 [Q1=5.0, Q3=12.0]. Two-year mean (95% CI) ODI improvement was 19.3% (16.7%; 21.9%; p<.001) for all age groups, with mean scores improved from a baseline of 46.3% (44.1%; 48.4%) to 41.1% (38.5%; 43.6%) at 10 weeks (p<.001), 28.1% (25.6%; 30.6%) at 12 months (p<.001), and 27.0% (24.4%; 29.5%) at 24 months (p<.001). At 2 years, 45.5% of patients showed 20% or greater improvement in ODI, 23.7% improved between 10% and 20%, 26.3% reported no change (defined as±10% from baseline), 4.5% of patients reported a worsening between 10% to 20%, and none reported worsening greater than 20%. 59.0% of patients were severely disabled (ODI >40%) pre-operatively, which decreased to 20.2% at 2 years. Significant improvement was observed across all 10 ODI items at 12 and 24 months. The largest improvements were seen in pain, walking, standing, sex life, social life and traveling., Conclusions: In this prospective, multicenter, multi-continental study of patients 60 years or older undergoing multi-level spinal deformity surgery, almost 70% of patients reported significant improvements in ODI without taking into account surgical indications, techniques or complications. Clear data is presented demonstrating the particular change from baseline for each decile of pre-operative ODI score, for each sub-score, and for each age group., (Copyright © 2021. Published by Elsevier Inc.)
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- 2021
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174. High Failure Rates of a Unilateral Posterior Peri-Apical Distraction Device (ApiFix) for Fusionless Treatment of Adolescent Idiopathic Scoliosis.
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Stadhouder A, Holewijn RM, Haanstra TM, van Royen BJ, Kruyt MC, and de Kleuver M
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- Adolescent, Female, Humans, Male, Orthopedic Procedures methods, Prospective Studies, Spinal Fusion, Orthopedic Procedures instrumentation, Prosthesis Failure, Scoliosis surgery
- Abstract
Background: Conventional surgical treatment for adolescent idiopathic scoliosis (AIS) consists of correction of the spinal deformity with rigid spinal instrumentation and fusion. Less-invasive and fusionless surgery could potentially improve patient outcomes. The purpose of the present study was to evaluate the efficacy of a recently U.S. Food and Drug Administration (FDA)-approved posterior peri-apical self-distracting device (ApiFix) that is designed to gradually correct the deformity without spinal fusion., Methods: In a prospective cohort study of 20 patients with AIS (Risser stage 1-4; Lenke 1 or 5; major curve Cobb angle, 40° to 55°; and Bunnell scoliometer rotation, <15°) were managed with the ApiFix device. Clinical and radiographic performance was assessed., Results: Twenty patients with a mean age (and standard deviation) of 14.8 ± 1.4 years were followed for a mean of 3.4 ± 1.0 years. The average major curve was reduced from 45.4° preoperatively to 31.4° at 2 weeks postoperatively and 31.0° at the time of the latest follow-up. The average minor curve measured 31.3° preoperatively, 26.1° at 2 weeks postoperatively, and 24.2° at the time of the latest follow-up. Ten patients had serious complications that required revision surgery, including osteolysis (n = 6), screw and/or rod breakage (n = 2), failure of the ratchet mechanism (n = 1), and pain without explainable cause (n = 1). During revision surgery, metallosis was observed in all patients and cultures showed growth of Cutibacterium acnes in 6 patients. Because of the high failure rate, the study was terminated early., Conclusions: The use of the unilateral peri-apical concave self-distracting ratchet rod initially was associated with promising clinical and radiographic results. However, no distraction was observed and the high rate of serious adverse events within 2 years was considered to be unacceptable for further clinical application of this device in our institution, despite recent FDA approval., Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence., Competing Interests: Disclosure: The Disclosure of Potential Conflicts of Interest forms are provided with the online version of the article (http://links.lww.com/JBJS/G538)., (Copyright © 2021 The Authors. Published by The Journal of Bone and Joint Surgery, Incorporated. All rights reserved.)
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- 2021
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175. Toward the Development of a Comprehensive Clinically Oriented Patient Profile: A Systematic Review of the Purpose, Characteristic, and Methodological Quality of Classification Systems of Adult Spinal Deformity.
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Kwan KYH, Naresh-Babu J, Jacobs W, de Kleuver M, Polly DW, Yilgor C, Wu Y, Park JB, Ito M, and van Hooff ML
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- Adult, Humans, Male, Practice Guidelines as Topic standards, Radiography, Reproducibility of Results, Scoliosis diagnostic imaging, Spinal Curvatures pathology, Spinal Curvatures therapy, Spine diagnostic imaging, Treatment Outcome, Scoliosis pathology, Spinal Curvatures classification, Spinal Curvatures diagnostic imaging, Spine pathology
- Abstract
Background: Existing adult spinal deformity (ASD) classification systems are based on radiological parameters but management of ASD patients requires a holistic approach. A comprehensive clinically oriented patient profile and classification of ASD that can guide decision-making and correlate with patient outcomes is lacking., Objective: To perform a systematic review to determine the purpose, characteristic, and methodological quality of classification systems currently used in ASD., Methods: A systematic literature search was conducted in MEDLINE, EMBASE, CINAHL, and Web of Science for literature published between January 2000 and October 2018. From the included studies, list of classification systems, their methodological measurement properties, and correlation with treatment outcomes were analyzed., Results: Out of 4470 screened references, 163 were included, and 54 different classification systems for ASD were identified. The most commonly used was the Scoliosis Research Society-Schwab classification system. A total of 35 classifications were based on radiological parameters, and no correlation was found between any classification system levels with patient-related outcomes. Limited evidence of limited quality was available on methodological quality of the classification systems. For studies that reported the data, intraobserver and interobserver reliability were good (kappa = 0.8)., Conclusion: This systematic literature search revealed that current classification systems in clinical use neither include a comprehensive set of dimensions relevant to decision-making nor did they correlate with outcomes. A classification system comprising a core set of patient-related, radiological, and etiological characteristics relevant to the management of ASD is needed., (© Congress of Neurological Surgeons 2021.)
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- 2021
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176. Intraoperative neuromonitoring practice patterns in spinal deformity surgery: a global survey of the Scoliosis Research Society.
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Dikmen PY, Halsey MF, Yucekul A, de Kleuver M, Hey L, Newton PO, Havlucu I, Zulemyan T, Yilgor C, and Alanay A
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- Humans, Neurosurgical Procedures, Retrospective Studies, Surveys and Questionnaires, Scoliosis surgery
- Abstract
Purpose: Although multimodal IONM has reached a widespread use, several unresolved issues have remained in clinical practice. The aim was to determine differences in approaches to form a basis for taking actions to improve patient safety globally., Methods: A survey comprising 19 questions in four sections (demographics, setup, routine practices and reaction to alerts) was distributed to the membership of the SRS., Results: Of the estimated 1300 members, 205 (~ 15%) completed the survey. Respondent demographics reflected SRS member distribution. Most of the respondents had > 10 years of experience. TcMEP and SSEP were available to > 95%. Less than 5% reported that a MD/PhD with neurophysiology background routinely examines patients preoperatively, while 19% would consult if requested. After an uneventful case, 36% reported that they would decrease sedation and check motor function if the patient was to be transferred to ICU intubated. Reactions to dropped signals that recovered or did not fully recover varied between attempting the same correction to aborting the surgery with no rods and returning another day, with or without implant removal. After a decrease of signals, 85.7% use steroids of varied doses. Of the respondents, 53.7% reported using the consensus-created checklist by Vitale et al. Approximately, 14% reported never using the wake-up test while others use it for various conditions., Conclusion: The responses of 205 experienced SRS members from different regions of the world showed that surgeons had different approaches in their routine IONM practices and in the handling of alerts. This survey indicates the need for additional studies to identify best practices.
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- 2021
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177. No added value of 2-year radiographic follow-up of fusion surgery for adolescent idiopathic scoliosis.
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Mens RH, van Hooff ML, Geuze RE, Spruit M, Horsting PP, de Kleuver M, and de Klerk LWL
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- Adolescent, Adult, Cohort Studies, Follow-Up Studies, Humans, Retrospective Studies, Thoracic Vertebrae, Treatment Outcome, Kyphosis, Scoliosis, Spinal Fusion
- Abstract
Purpose: For fusion surgery in adolescent idiopathic scoliosis (AIS) consensus exists that a 2-year radiographic follow-up assessment is needed. This standard lacks empirical evidence. The purpose of this study was to investigate the radiographic follow-up after corrective surgery in AIS, from pre-until 2 years postoperative., Methods: In this historical cohort study, 63 patients surgically treated for AIS, age ≤ 25 years, with 2-year radiographic follow-up, were enrolled. The primary outcome measure was the major Cobb angle. Secondary outcomes were coronal and sagittal spino-pelvic parameters, including proximal junction kyphosis (PJK) and distal adding-on. Change over time was analyzed using a repeated measures ANOVA., Results: The major curve Cobb angle showed a statistically significant change for pre- to 1 year postoperative, but not for 1- to 2-year follow-up. Seven out of 63 patients did show a change exceeding the error of measurement (5°) from 1- to 2-year follow-up (range -8° to +7°), of whom 2 patients showed curve progression and 5 showed improvement. PJK or distal adding-on was not observed., Conclusions: No statistically significant changes in major curve Cobb angle were found during postsurgical follow-up, or in adjacent non-fused segments. The findings of this study are not supportive for routine radiographs 2 years after fusion surgery in AIS patients.
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- 2021
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178. Neurophysiological monitoring of spinal cord function during spinal deformity surgery: 2020 SRS neuromonitoring information statement.
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Halsey MF, Myung KS, Ghag A, Vitale MG, Newton PO, and de Kleuver M
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- Anesthesia, Electromyography, Evoked Potentials, Motor, Evoked Potentials, Somatosensory, Humans, Intraoperative Complications diagnosis, Intraoperative Complications etiology, Intraoperative Complications prevention & control, Patient Care Team, Risk, Spinal Cord Diseases diagnosis, Spinal Cord Diseases etiology, Spinal Cord Diseases prevention & control, Intraoperative Neurophysiological Monitoring methods, Intraoperative Neurophysiological Monitoring standards, Spinal Cord physiology, Spinal Curvatures surgery
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The Scoliosis Research Society has developed an updated information statement on intraoperative neurophysiological monitoring of spinal cord function during spinal deformity surgery. The statement reviews the risks of spinal cord compromise associated with spinal deformity surgery; the statement then discusses the various modalities that are available to monitor the spinal cord, including somatosensory-evoked potentials, motor-evoked potentials, and electromyographic (EMG) options. Anesthesia considerations, the importance of a thoughtful team approach to successful monitoring, and the utility of checklists are also discussed. Finally, the statement expresses the opinion that utilization of intraoperative neurophysiological spinal cord monitoring in spinal deformity surgery is the standard of care when the spinal cord is at risk.
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- 2020
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179. [Complexity of disease; a modern view in times of ageing populations and multimorbidity].
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Olde Rikkert MGM, van Zuijlen PPM, de Kleuver M, van Reekum A, Hoekstra AG, and Sloot PMA
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- Aged, Biomedical Research organization & administration, Computer Simulation, Humans, Aging, Multimorbidity trends, Multiple Chronic Conditions therapy
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Complexity of patient care is rapidly increasing as a consequence of rising numbers of patients with complex multimorbidity. Not just the patient as a whole, but also the networks of organs, tissues and cells are forming a complex adaptive system (CAS). A CAS is defined as a network of several components ('agents') with lots of mutual feedback loops between which there are circular causalities; the predictability of a CAS is limited by definition. However, current guidelines and evidence-based medicine assume that diseases and the medical interventions to address them are predictable. Physicians' brains are complex neural networks that are much better at dealing with complex situations than guidelines. In the near future, physicians will also get help from advanced computer simulation models that make better diagnostic analyses on the basis of detailed phenotyping and are more accurate when predicting possible courses of disease and treatment outcomes.
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- 2019
180. Predictive factors for brace treatment outcome in adolescent idiopathic scoliosis: a best-evidence synthesis.
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van den Bogaart M, van Royen BJ, Haanstra TM, de Kleuver M, and Faraj SSA
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- Adolescent, Child, Female, Humans, Male, Treatment Outcome, Braces, Scoliosis epidemiology, Scoliosis therapy
- Abstract
Purpose: To evaluate predictive factors for brace treatment outcome in adolescent idiopathic scoliosis (AIS) by a systematic review of the literature., Methods: Eligible studies evaluating one or more predictive factors for brace treatment outcome were included following a systematic search in PubMed and EMBASE on October 23, 2017. Inclusion criteria were: (1) subjects diagnosed with AIS, (2) age ≤ 18 years, (3) treated with a thoraco-lumbo-sacral orthosis (TLSO), and (4) evaluated one or more predictive factors of treatment outcome (failure and/or success). The methodological quality of included studies was independently assessed by two authors. Pooling was not possible due to heterogeneity in statistical analysis. Predictive factors were presented according to a best-evidence synthesis., Results: The literature search identified 26 studies that met the inclusion criteria, and multiple types of TLSO braces were identified (Boston, Wilmington, Chêneau, Osaka Medical College, Dresdner Scoliosis Orthosis and SPoRT). A total of 19 radiographic and 8 clinical predictive factors were reported. Strong evidence was found that lack of initial in-brace correction is associated with treatment failure. Moderate evidence suggests that brace wear time is associated with failure and success, whereas initial curve magnitude and curve type are not., Conclusion: The results of this review suggest that lack of initial in-brace correction is strongly associated with brace treatment failure. Future studies on the threshold for minimal immediate in-brace correction, as a potential indication for brace treatment, are recommended. These slides can be retrieved under Electronic Supplementary Material.
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- 2019
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181. Radiographic Axial Malalignment is Associated With Pretreatment Patient-Reported Health-Related Quality of Life Measures in Adult Degenerative Scoliosis: Implementation of a Novel Radiographic Software Tool.
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Faraj SSA, Boselie TFM, Vila-Casademunt A, de Kleuver M, Holewijn RM, Obeid I, Acaroglu E, Alanay A, Kleinstück F, Pérez-Grueso FS, and Pellisé F
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- Aged, Female, Humans, Male, Radiography, Retrospective Studies, Software, Quality of Life, Scoliosis diagnostic imaging
- Abstract
Study Design: Retrospective study of prospectively collected data., Objectives: The purpose of this study was to evaluate the relationship between apical vertebral axial rotation and pretreatment patient-reported health-related quality of life (HRQOL), disability, and pain in patients with adult degenerative scoliosis (ADS) using a novel radiographic software tool., Summary of Background Data: Recent studies have demonstrated that in ADS, sagittal and coronal plane deformity are weakly to moderately associated with HRQOL, disability, and pain. However, as ADS is a three-dimensional spinal deformity, the impact of axial malalignment on HRQOL is yet to be determined., Methods: A total of 74 ADS patients were enrolled. HRQOL measures included the Short Form-36v2 (SF-36v2) and Scoliosis Research Society questionnaire (SRS-22r). Disability and pain measures included the Oswestry Disability Index (ODI) and numeric rating scale back and leg pain. Radiographic measures included Cobb angle (CA), sagittal spinopelvic parameters, lateral and anteroposterior (AP) translation of the apical vertebra. The amount of apical vertebral axial rotation was measured on digital AP radiograph images using a novel software technology. Subjects were stratified into four clinical groups based on the degree of apical vertebral axial rotation., Results: Apical vertebral axial rotation showed no association with lateral (r = 0.21; p = .15) and AP (r = 0.08, p = .80) translation of the apical vertebra. A significant moderate association was found between apical vertebral axial rotation and Cobb angle (r = 0.57; p < .05). Patients in the group with the highest degree of apical vertebral axial rotation reported significantly worse ODI and SRS-22r Subtotal and Pain scores (p < .05), irrespective of sagittal spinopelvic parameters., Conclusions: This is the first study that reports on the association between apical vertebral axial rotation and pretreatment HRQOL, disability, and pain in ADS. This study suggests that increased apical vertebral axial rotation is associated with suboptimal pretreatment health status scores., Level of Evidence: Level III., (Copyright © 2018 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.)
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- 2018
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182. What are the risk factors for surgical site infection after spinal fusion? A meta-analysis.
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Pesenti S, Pannu T, Andres-Bergos J, Lafage R, Smith JS, Glassman S, de Kleuver M, Pellise F, Schwab F, and Lafage V
- Subjects
- Cohort Studies, Diabetes Complications, Humans, Lumbar Vertebrae surgery, Obesity complications, Odds Ratio, Operative Time, Osteotomy adverse effects, Retrospective Studies, Risk Factors, Spinal Diseases surgery, Thoracic Vertebrae surgery, Spinal Fusion adverse effects, Surgical Wound Infection etiology
- Abstract
Purpose: Although many risk factors for surgical site infection (SSI) following spinal fusion have been described in the literature, methodologies and study cohorts vary widely. Patient- and procedure-specific risk factors for (SSI) can be identified via a meta-analysis. We sought to review the existing data and isolate significant risk factors for SSI in patients undergoing thoracolumbar spinal fusion., Methods: The literature was searched through December of 2016. Studies including adult patients undergoing thoracolumbar spinal fusion surgery (single or multilevel, anterior, posterior or combined approach) were identified. Only studies that included an odds ratio (OR) for SSI or sufficient data to calculate it were included. A meta-analysis was performed using RevMan 5.1. Depending on heterogeneity (I
2 ), OR with 95% confidence intervals was calculated using either the fixed-effects model (when I2 < 60%) or the random-effects model (when I2 > 60%)., Results: 6482 manuscripts were identified and reviewed. 29 manuscripts with 374,488 patients met the criteria for inclusion. Twelve risk factors were assessed by the meta-analysis and grouped into two categories (patient related and procedure related). Significant patient-related factors for SSI included obesity, diabetes, ASA score, tobacco use and revision status. Procedure-related risk factors included operative time, use of osteotomy, fusion length and extension of fusion to the sacrum or pelvis., Conclusions: This meta-analysis identified significant risk factors for SSI following spine arthrodesis. These included potentially modifiable factors such as obesity, diabetes, smoking status and procedure-related parameters. Non-modifiable risk factors were identified, including ASA score and age. These factors may prove useful for patient counseling as well as surgical planning., Level of Evidence: Level III (Meta-analysis including studies with a level of evidence of III or higher). These slides can be retrieved under Electronic Supplementary Material.- Published
- 2018
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183. High incidence of intraoperative calcar fractures with the cementless CLS Spotorno stem.
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Timmer C, Gerhardt DMJM, de Visser E, de Kleuver M, and van Susante JLC
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- Female, Femoral Fractures diagnosis, Femoral Fractures etiology, Follow-Up Studies, Hip Joint diagnostic imaging, Humans, Incidence, Intraoperative Complications diagnosis, Intraoperative Complications etiology, Male, Middle Aged, Netherlands epidemiology, Prosthesis Design, Radiography, Retrospective Studies, Arthroplasty, Replacement, Hip adverse effects, Femoral Fractures epidemiology, Hip Joint surgery, Hip Prosthesis adverse effects, Intraoperative Complications epidemiology
- Abstract
Introduction: This study reports on the incidence of intraoperative calcar fractures with the cementless Spotorno (CLS) stem, and the potential role of a learning curve and implant positioning is investigated., Methods: After introduction of the CLS stem, 800 consecutive cementless total hip arthroplasties (THA) were analyzed. The incidence of calcar fracture in the first 400 THA was compared with the second 400 THA, in order to study a potential learning curve effect. According to the instruction for users, varus positioning of the stem was avoided and a femoral neck osteotomy was aimed relatively close to the lesser trochanter since these are assumed to be correlated with calcar fractures. Implant positioning (neck-shaft angle, femoral offset and osteotomy-lesser trochanter distance) was measured on postoperative pelvic radiographs of all THA with calcar fractures and 100 randomly selected uncomplicated control cases., Results: Seventeen (2.1%) intraoperative calcar fractures were recorded. The incidence of calcar fracture differed between the first 400 THA (n = 11) and the second 400 THA (n = 6). This difference was not statistically significant (p = 0.220); however, these numbers indicate a trend toward a learning effect. No significant difference in stem positioning nor the height of the femoral neck osteotomy was measured between THA with a calcar fracture (n = 17) and the control cases (n = 100)., Conclusions: We report on a high incidence of intraoperative calcar fractures with the use of a CLS stem. The risk for calcar fractures remains clinically significant even after adequate implant positioning in the hands of experienced hip surgeons. Surgeons should be aware of this implant related phenomenon and be alert on this phenomenon intraoperatively.
- Published
- 2018
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184. Precision Spine Care: A New Era of Discovery, Innovation, and Global Impact.
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Samartzis D, Alini M, An HS, Karppinen J, Rajasekaran S, Vialle L, Wang JC, and de Kleuver M
- Published
- 2018
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185. An international consensus on the appropriate evaluation and treatment for adults with spinal deformity.
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Berven SH, Kamper SJ, Germscheid NM, Dahl B, Shaffrey CI, Lenke LG, Lewis SJ, Cheung KM, Alanay A, Ito M, Polly DW, Qiu Y, and de Kleuver M
- Subjects
- Adult, Aged, Delphi Technique, Diagnostic Imaging, Female, Humans, Male, Medical History Taking, Middle Aged, Physical Examination, Postoperative Complications prevention & control, Spinal Curvatures diagnostic imaging, Venous Thrombosis prevention & control, Orthopedic Procedures standards, Postoperative Care standards, Preoperative Care standards, Spinal Curvatures surgery
- Abstract
Purpose: Evaluation and surgical management for adult spinal deformity (ASD) patients varies between health care providers. The purpose of this study is to identify appropriateness of specific approaches and management strategies for the treatment of ASD., Methods: From January to July 2015, the AOSpine Knowledge Deformity Forum performed a modified Delphi survey where 53 experienced deformity surgeons from 24 countries, rated the appropriateness of management strategies for multiple ASD clinical scenarios. Four rounds were performed: three surveys and a face-to-face meeting. Consensus was achieved with ≥70% agreement., Results: Appropriate surgical goals are improvement of function, pain, and neural symptoms. Appropriate preoperative patient evaluation includes recording information on history and comorbidities, and radiographic workup, including long standing films and MRI for all patients. Preoperative pulmonary and cardiac testing and DEXA scan is appropriate for at-risk patients. Intraoperatively, appropriate surgical strategies include long fusions with deformity correction for patients with large deformity and sagittal imbalance, and pelvic fixation for multilevel fusions with large curves, sagittal imbalance, and osteoporosis. Decompression alone is inappropriate in patients with large curves, sagittal imbalance, and progressive deformity. It is inappropriate to fuse to L5 in patients with symptomatic disk degeneration at L5-S1., Conclusions: These results provide guidance for informed decision-making in the evaluation and management of ASD. Appropriate care for ASD, a very diverse spectrum of disease, must be responsive to patient preference and values, and considerations of the care provider, and the healthcare system. A monolithic approach to care should be avoided.
- Published
- 2018
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186. Asymmetrical trunk movement during walking improved to normal range at 3 months after corrective posterior spinal fusion in adolescent idiopathic scoliosis.
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Wong-Chung DACF, Schimmel JJP, de Kleuver M, and Keijsers NLW
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- Adolescent, Biomechanical Phenomena, Child, Female, Gait physiology, Humans, Movement physiology, Range of Motion, Articular, Reference Values, Scoliosis physiopathology, Scoliosis rehabilitation, Scoliosis surgery, Spinal Fusion methods, Torso physiopathology, Walking physiology
- Abstract
Purpose: To investigate the effects of posterior spinal fusion (PSF) and curve type on upper body movements in Adolescent Idiopathic Scoliosis (AIS) patients during gait., Methods: Twenty-four girls (12-18 years) with AIS underwent PSF. 3D-Gait-analyses were performed preoperatively, at 3 months and 1 year postoperatively. Mean position (0° represents symmetry) and range of motion (ROM) of the trunk (thorax-relative-to-pelvis) in all planes were assessed. Lower body kinematics and spatiotemporal parameters were also evaluated., Results: Mean trunk position improved from 7.0° to 2.9° in transversal plane and from 5.0° to - 0.8° in frontal plane at 3 months postoperative (p < 0.001), and was maintained at 1 year. Trunk ROM in transverse plane decreased from 9.6° to 7.5° (p < 0.001) after surgery. No effects of PSF were observed on the lower body kinematics during the gait cycle. Patients with a double curve had a more axial rotated trunk before and after surgery (p = 0.013)., Conclusion: In AIS patients, during gait an evident asymmetrical position of the trunk improved to an almost symmetric situation already 3 months after PSF and was maintained at 1 year. Despite a reduction of trunk ROM, patients were able to maintain the same walking pattern in the lower extremities after surgery. This improvement of symmetry and maintenance of normal gait can explain the rapid recovery and well functioning in daily life of AIS patients, despite undergoing a fusion of large parts of their spine.
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- 2018
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187. Which patient-reported factors predict referral to spinal surgery? A cohort study among 4987 chronic low back pain patients.
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van Dongen JM, van Hooff ML, Spruit M, de Kleuver M, and Ostelo RWJG
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- Cohort Studies, Female, Humans, Male, Prospective Studies, Self Report, Chronic Pain epidemiology, Chronic Pain surgery, Low Back Pain epidemiology, Low Back Pain surgery, Referral and Consultation statistics & numerical data
- Abstract
Purpose: It is unknown which chronic low back pain (CLBP) patients are typically referred to spinal surgery. The present study, therefore, aimed to explore which patient-reported factors are predictive of spinal surgery referral among CLBP patients., Methods: CLBP patients were consecutively recruited from a Dutch orthopedic hospital specialized in spine care (n = 4987). The outcome of this study was referral to spinal surgery (yes/no), and was assessed using hospital records. Possible predictive factors were assessed using a screening questionnaire. A prediction model was constructed using logistic regression, with backwards selection and p < 0.10 for keeping variables in the model. The model was internally validated and evaluated using discrimination and calibration measures., Results: Female gender, previous back surgery, high intensity leg pain, somatization, and positive treatment expectations increased the odds of being referred to spinal surgery, while being obese, having comorbidities, pain in the thoracic spine, increased walking distance, and consultation location decreased the odds. The model's fit was good (X
2 = 10.5; p = 0.23), its discriminative ability was poor (AUC = 0.671), and its explained variance was low (5.5%). A post hoc analysis indicated that consultation location was significantly associated with spinal surgery referral, even after correcting for case-mix variables., Conclusion: Some patient-reported factors could be identified that are predictive of spinal surgery referral. Although the identified factors are known as common predictive factors of surgery outcome, they could only partly predict spinal surgery referral.- Published
- 2017
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188. Measuring outcomes in adult spinal deformity surgery: a systematic review to identify current strengths, weaknesses and gaps in patient-reported outcome measures.
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Faraj SSA, van Hooff ML, Holewijn RM, Polly DW Jr, Haanstra TM, and de Kleuver M
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- Adult, Humans, Orthopedic Procedures, Patient Reported Outcome Measures, Spinal Curvatures surgery
- Abstract
Purpose: Adult spinal deformity (ASD) causes severe disability, reduces overall quality of life, and results in a substantial societal burden of disease. As healthcare is becoming more value based, and to facilitate global benchmarking, it is critical to identify and standardize patient-reported outcome measures (PROMs). This study aims to identify the current strengths, weaknesses, and gaps in PROMs used for ASD., Methods: Studies were included following a systematic search in multiple bibliographic databases between 2000 and 2015. PROMs were extracted and linked to the outcome domains of WHO's International Classification of Functioning and Health (ICF) framework. Subsequently, the clinimetric quality of identified PROMs was evaluated., Results: The literature search identified 144 papers that met the inclusion criteria, and nine frequently used PROMs were identified. These covered 29 ICF outcome domains, which could be grouped into three of the four main ICF chapters: body function (n = 7), activity and participation (n = 19), environmental factors (n = 3), and body structure (n = 0). A low quantity (n = 3) of papers was identified that studied the clinimetric quality of PROMs. The Scoliosis Research Society (SRS)-22 has the highest level of clinimetric quality for ASD., Conclusions: Outcome domains related to mobility and pain were well represented. We identified a gap in current outcome measures regarding neurological and pulmonary function. In addition, no outcome domains were measured in the ICF chapter body structure. These results will serve as a foundation for the process of seeking international consensus on a standard set of outcome domains, accompanied PROMs and contributing factors to be used in future clinical trials and spine registries.
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- 2017
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189. De novo degenerative lumbar scoliosis: a systematic review of prognostic factors for curve progression.
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Faraj SS, Holewijn RM, van Hooff ML, de Kleuver M, Pellisé F, and Haanstra TM
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- Disease Progression, Humans, Intervertebral Disc Degeneration epidemiology, Lordosis, Osteophyte diagnostic imaging, Osteophyte epidemiology, Osteoporosis diagnostic imaging, Osteoporosis epidemiology, Prognosis, Risk Factors, Rotation, Scoliosis epidemiology, Spondylolisthesis diagnostic imaging, Spondylolisthesis epidemiology, Intervertebral Disc Degeneration diagnostic imaging, Lumbar Vertebrae diagnostic imaging, Scoliosis diagnostic imaging
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Purpose: To identify prognostic factors for curve progression in de novo degenerative lumbar scoliosis (DNDLS) by performing a systematic review of the literature., Methods: Studies were selected for inclusion following a systematic search in the bibliographic databases PubMed and EMBASE prior to September 2015 and hand searches of the reference lists of retrieved articles. Two authors independently assessed methodological quality. Data were extracted and presented according to a best evidence synthesis., Results: The literature search generated a total of 2696 references. After removing duplicates and articles that did not meet inclusion criteria, 12 studies were included. Due to the lack of statistical analyses, pooling of data was not possible. Strong evidence indicates that increasing intervertebral disk degeneration, lateral vertebral translation ≥6 mm, and an intercrest line through L5 (rather than L4) are associated with DNDLS curve progression. Moderate evidence suggests that apical vertebral rotation Grade II or III is associated with curve progression. For the majority of other prognostic factors, we found limited, conflicting, or inconclusive evidence. Osteoporosis, a coronal Cobb angle <30°, lumbar lordosis, lateral osteophytes difference of ≥5 mm, and degenerative spondylolisthesis have not been shown to be risk factors. Clinical risk factors for progression were not identified., Conclusions: This review shows strong evidence that increased intervertebral disk degeneration, an intercrest line through L5, and apical lateral vertebral translation ≥6 mm are associated with DNDLS curve progression. Moderate evidence was found for apical vertebral rotation (Grade II/III) as a risk factor for curve progression. These results, however, may not be directly applicable to the individual patient.
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- 2016
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190. How Does Spinal Release and Ponte Osteotomy Improve Spinal Flexibility? The Law of Diminishing Returns.
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Holewijn RM, Schlösser TP, Bisschop A, van der Veen AJ, Stadhouder A, van Royen BJ, Castelein RM, and de Kleuver M
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Study Design: Experimental study., Objectives: To evaluate the effect of stepwise resection of posterior spinal ligaments, facet joints, and ribs on thoracic spinal flexibility., Summary of Background Data: Posterior spinal ligaments, facet joints and ribs are removed to increase spinal flexibility in corrective spinal surgery for deformities such as adolescent idiopathic scoliosis (AIS). Reported clinical results vary and biomechanical substantiation is lacking., Methods: Ten fresh-frozen human cadaveric thoracic spinal specimens (T6-T11) were studied. A spinal motion simulator applied a pure moment of ±2.5 Nm in flexion, extension, lateral bending (LB) and axial rotation (AR). Range of motion (ROM) was measured for the intact spine and measured again after stepwise resection of the supra/interspinous ligament (SIL), inferior facet, flaval ligament, superior facet, and rib heads., Results: SIL resection increased ROM in flexion (10.2%) and AR (3.1%). Successive inferior facetectomy increased ROM in flexion (4.1%), LB (3.8%) and AR (7.7%), and flavectomy in flexion (9.1%) and AR (2.5%). Sequential superior facetectomy only increased ROM in flexion (6.3%). Rib removal provided an additional increase in flexion (6.3%), LB (4.5%) and AR (13.0%). Extension ROM increased by 10.5% after the combined removal of the SIL, inferior facet and flaval ligament., Conclusions: Posterior spinal releases in these non-scoliotic spines led to an incremental increase in spinal flexibility, but each sequential step had less effect. As compared to SIL resection with inferior facetectomy, additional superior facetectomy did not improve flexibility in AR and LB and only 6.3% in flexion. The data presented from this in vitro study should be interpreted with care, as no representative cadaveric spine model for AIS was available, However, the results presented here at least question the benefits of performing routine complete facetectomies (i.e. Ponte osteotomies) to increase spinal flexibility in scoliosis surgery., (Copyright © 2015 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2015
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191. Evidence and practice in spine registries.
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van Hooff ML, Jacobs WC, Willems PC, Wouters MW, de Kleuver M, Peul WC, Ostelo RW, and Fritzell P
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- Humans, Treatment Outcome, Quality of Health Care statistics & numerical data, Registries statistics & numerical data, Spinal Diseases therapy
- Abstract
Background and Purpose: We performed a systematic review and a survey in order to (1) evaluate the evidence for the impact of spine registries on the quality of spine care, and with that, on patient-related outcomes, and (2) evaluate the methodology used to organize, analyze, and report the "quality of spine care" from spine registries., Methods: To study the impact, the literature on all spinal disorders was searched. To study methodology, the search was restricted to degenerative spinal disorders. The risk of bias in the studies included was assessed with the Newcastle-Ottawa scale. Additionally, a survey among registry representatives was performed to acquire information about the methodology and practice of existing registries., Results: 4,273 unique references up to May 2014 were identified, and 1,210 were eligible for screening and assessment. No studies on impact were identified, but 34 studies were identified to study the methodology. Half of these studies (17 of the 34) were judged to have a high risk of bias. The survey identified 25 spine registries, representing 14 countries. The organization of these registries, methods used, analytical approaches, and dissemination of results are presented., Interpretation: We found a lack of evidence that registries have had an impact on the quality of spine care, regardless of whether intervention was non-surgical and/or surgical. To improve the quality of evidence published with registry data, we present several recommendations. Application of these recommendations could lead to registries showing trends, monitoring the quality of spine care given, and ultimately improving the value of the care given to patients with degenerative spinal disorders.
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- 2015
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192. Optimal surgical care for adolescent idiopathic scoliosis: an international consensus.
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de Kleuver M, Lewis SJ, Germscheid NM, Kamper SJ, Alanay A, Berven SH, Cheung KM, Ito M, Lenke LG, Polly DW, Qiu Y, van Tulder M, and Shaffrey C
- Subjects
- Adolescent, Adult, Aged, Bone Transplantation, Delphi Technique, Female, Humans, Intraoperative Care, Male, Middle Aged, Pain Management, Pedicle Screws, Postoperative Care, Preoperative Care, Radiography, Scoliosis diagnostic imaging, Spinal Fusion, Surgical Wound Infection prevention & control, Scoliosis surgery
- Abstract
Purpose: The surgical management of adolescent idiopathic scoliosis (AIS) has seen many developments in the last two decades. Little high-level evidence is available to support these changes and guide treatment. This study aimed to identify optimal operative care for adolescents with AIS curves between 40° and 90° Cobb angle., Methods: From July 2012 to April 2013, the AOSpine Knowledge Forum Deformity performed a modified Delphi survey where current expert opinion from 48 experienced deformity surgeons, representing 29 diverse countries, was gathered. Four rounds were performed: three web-based surveys and a final face-to-face meeting. Consensus was achieved with ≥ 70% agreement. Data were analyzed qualitatively and quantitatively., Results: Consensus of what constitutes optimal care was reached on greater than 60 aspects including: preoperative radiographs; posterior as opposed to anterior (endoscopic) surgical approaches; use of intraoperative spinal cord monitoring; use of local autologous bone (not iliac crest) for grafts; use of thoracic and lumbar pedicle screws; use of titanium anchor points; implant density of <80% for 40°-70° curves; and aspects of postoperative care. Variability in practice patterns was found where there was no consensus. In addition, there was consensus on what does not constitute optimal care, including: routine pre- and intraoperative traction; routine anterior release; use of bone morphogenetic proteins; and routine postoperative CT scanning., Conclusions: International consensus was found on many aspects of what does and does not constitute optimal operative care for adolescents with AIS. In the absence of current high-level evidence, at present, these expert opinion findings will aid health care providers worldwide define appropriate care in their regions. Areas with no consensus provide excellent insight and priorities for future research.
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- 2014
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193. Effective nonoperative treatment in juvenile idiopathic scoliosis.
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van Hessem L, Schimmel JJ, Graat HC, and de Kleuver M
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- Braces, Casts, Surgical, Child, Child, Preschool, Cohort Studies, Female, Humans, Male, Orthopedic Procedures, Scoliosis therapy
- Abstract
Nonoperative management of juvenile idiopathic scoliosis (JIS) has been reported to be less effective than that of infantile idiopathic scoliosis. The goal of this study was to analyse the results of casting and/or bracing in JIS. Clinical data from seven patients with JIS, treated with casting followed by bracing (n=3) or by bracing alone (n=4), were retrospectively collected, and curve severity was measured before, during and after treatment. The median Cobb angle decreased from 37° to 25°. No patient needed surgery at a median follow-up of 4.6 years (3.4-9.1 years). Casting and/or bracing is effective for the management of JIS.
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- 2014
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194. Torsion biomechanics of the spine following lumbar laminectomy: a human cadaver study.
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Bisschop A, van Dieën JH, Kingma I, van der Veen AJ, Jiya TU, Mullender MG, Paul CP, de Kleuver M, and van Royen BJ
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- Absorptiometry, Photon, Aged, Aged, 80 and over, Biomechanical Phenomena, Bone Density, Cadaver, Female, Humans, Intervertebral Disc Degeneration classification, Lumbar Vertebrae pathology, Magnetic Resonance Imaging, Male, Middle Aged, Range of Motion, Articular, Spine pathology, Weight-Bearing, Laminectomy, Lumbar Vertebrae surgery, Spine surgery, Torsion, Mechanical
- Abstract
Purpose: Lumbar laminectomy affects spinal stability in shear loading. However, the effects of laminectomy on torsion biomechanics are unknown. The purpose of this study was to investigate the effect of laminectomy on torsion stiffness and torsion strength of lumbar spinal segments following laminectomy and whether these biomechanical parameters are affected by disc degeneration and bone mineral density (BMD)., Methods: Ten human cadaveric lumbar spines were obtained (age 75.5, range 59-88). Disc degeneration (MRI) and BMD (DXA) were assessed. Disc degeneration was classified according to Pfirrmann and dichotomized in mild or severe. BMD was defined as high BMD (≥median BMD) or low BMD (
- Published
- 2013
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195. Can a triple pelvic osteotomy for adult symptomatic hip dysplasia provide relief of symptoms for 25 years?
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van Stralen RA, van Hellemondt GG, Ramrattan NN, de Visser E, and de Kleuver M
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- Adolescent, Adult, Disease Progression, Female, Follow-Up Studies, Hip Dislocation diagnostic imaging, Hip Joint diagnostic imaging, Humans, Male, Middle Aged, Osteoarthritis, Hip diagnostic imaging, Osteoarthritis, Hip surgery, Pain diagnostic imaging, Pain Measurement, Pelvic Bones diagnostic imaging, Radiography, Range of Motion, Articular, Time Factors, Treatment Outcome, Hip Dislocation surgery, Hip Joint surgery, Osteotomy methods, Pain surgery, Pelvic Bones surgery
- Abstract
Background: Many surgeons recommend pelvic osteotomy to treat symptomatic hip dysplasia in younger patients. We previously reported a cohort of patients at 10 and 15 years followup in which 65% of the patients showed no progression of osteoarthritis (OA)., Questions/purposes: The purposes of this study were to determine whether the triple osteotomy can provide (1) continuing pain relief and (2) function; and to determine the (3) incidence of OA and (4) number of patients undergoing THAs 23 years or more after triple osteotomy., Methods: Between 1980 and 1987, 51 pelvic osteotomies were performed in 43 patients (38 females and five males; mean age, 28 years; range, 14-48 years). Followup was obtained for 40 patients (49 of 51 hips; 96%). Clinical evaluation, including pain, mobility, and ROM, was graded according to the subgroups of the modified scoring system of Merle d'Aubigné and Postel. The minimum followup was 23 years (mean, 25 years; range, 23-29 years)., Results: The mean VAS pain score increased from 27 mm to 31 mm at the last followup, but remained substantially lower than before surgery. The mean Merle d'Aubigné-Postel score improved from 13 preoperatively to 15 at a mean of 10 years followup but at last followup, the mean score had decreased to 14, thereby showing a trend to diminish. At 15 years followup, 20 patients showed signs of OA. At 25 years followup, 18 of 33 patients without THAs showed signs of OA (55%). Six patients (six hips) had undergone THAs at 15 years, increasing to 15 patients (16 hips) at 25 years., Conclusion: While the triple osteotomy for symptomatic developmental dysplasia of the hip in young adults provides substantial pain relief and restores function in most patients, these results deteriorate over decades owing to the development of OA. Even in joints without preoperative OA, a THA cannot always be avoided. The triple osteotomy does not normalize the joint and the incidence of THA in this group of patients (32%) is much higher than in the general population., Level of Evidence: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
- Published
- 2013
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196. A short, intensive cognitive behavioral pain management program reduces health-care use in patients with chronic low back pain: two-year follow-up results of a prospective cohort.
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van Hooff ML, Ter Avest W, Horsting PP, O'Dowd J, de Kleuver M, van Lankveld W, and van Limbeek J
- Subjects
- Adult, Chronic Disease, Cohort Studies, Disability Evaluation, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, Outcome Assessment, Health Care, Pain Measurement, Prospective Studies, Quality of Life psychology, Treatment Outcome, Cognitive Behavioral Therapy methods, Delivery of Health Care statistics & numerical data, Low Back Pain psychology, Low Back Pain therapy, Pain Management methods
- Abstract
Purpose: Cognitive behavioral interventions are recommended as non-invasive treatment options for patients with chronic low back pain (CLBP). However, most treatment effects are small and short-lived. Although a 2-week intensive pain management program for patients with CLBP seems to be effective, the long-term results are not known. The purpose of this study is to evaluate the stability of the 2-year follow-up results and whether this is reflected in the use of health-care services., Methods: A prospective cohort study was performed. Pre-treatment characteristics of patients and data of outcomes obtained at 1-year follow-up were used. At 2-year follow-up a structured interview was conducted following the principles of a post-marketing survey. Outcomes included daily functioning, quality of life, current intensity of pain, disturbance of pain during daily activities, and indicators of the use of pain medication and health-care services., Results: Of the 90 eligible patients 85 (94%) participated in the post-marketing survey. The 1-year clinical relevant effects are maintained at 2-year follow-up. Effect sizes for functioning and quality of life were large. More than 65% reached preset minimal clinically important differences. At pre-treatment all patients consulted their general practitioner (GP) and medical specialist (MS). At 2-year follow-up 73% reported having consulted neither a GP nor an MS during the previous year. Most of the patients indicated not to use any pain medication (57%) and the percentage patients using opioids have decreased (14%). Moreover, 81% reported to be at work., Conclusions: The gained results from selected and motivated patients with longstanding CLBP at 1-year follow-up are stable at 2-year follow-up. Above all, most of the participants are at work and results indicate that the use of both pain medication and health care have decreased substantially.
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- 2012
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197. Pre-existent vertebral rotation in the human spine is influenced by body position.
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Janssen MM, Vincken KL, Kemp B, Obradov M, de Kleuver M, Viergever MA, Castelein RM, and Bartels LW
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- Adult, Female, Humans, Male, Scoliosis etiology, Scoliosis physiopathology, Spine physiopathology, Young Adult, Posture physiology, Rotation adverse effects, Scoliosis pathology, Spine pathology
- Abstract
Both the humans as well as the quadrupedal spine have been shown to exhibit a pattern of pre-existent rotation that is similar in direction to what is found in the most common types of idiopathic scoliosis. It has been postulated that human bipedalism introduces forces to the spine that increase a tendency of the vertebrae to rotate. The objective of this study was to examine the effect of body position on vertebral rotation in vivo. Thirty asymptomatic volunteers underwent magnetic resonance imaging scanning of the spine (T2-L5) in three different body positions; upright, quadrupedal-like (on hands-and-knees) and supine. Vertebral rotation in the local transverse plane was measured according to a pre-established method and compared at different spinal levels between the three body positions. It was shown that in all three positions the mid- and lower thoracic vertebrae were predominantly rotated to the right. However, vertebral rotation was significantly less in the quadrupedal position than in both the standing upright and supine positions.
- Published
- 2010
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198. Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management.
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van Hooff ML, van der Merwe JD, O'Dowd J, Pavlov PW, Spruit M, de Kleuver M, and van Limbeek J
- Subjects
- Adult, Chronic Disease, Cohort Studies, Disability Evaluation, Female, Humans, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Young Adult, Cognitive Behavioral Therapy methods, Low Back Pain rehabilitation, Outcome Assessment, Health Care methods, Recovery of Function, Self Care methods
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Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen's d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes.
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- 2010
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199. Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment.
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Bunge EM, Juttmann RE, de Kleuver M, van Biezen FC, and de Koning HJ
- Subjects
- Adolescent, Cross-Sectional Studies, Female, Health Surveys, Humans, Male, Patient Satisfaction, Treatment Outcome, Braces, Health Status, Orthopedic Procedures, Quality of Life, Scoliosis complications, Scoliosis therapy
- Abstract
For treatment of teenagers with progressive adolescent idiopathic scoliosis in an early stage, two options are generally considered: treatment with a brace or observation followed by surgery if necessary. Many doctors and patients prefer conservative treatment (i.e. brace treatment) to surgical treatment, because surgery of the spine is generally considered a drastic intervention. Because potential differences in health-related quality of life (HRQoL) after treatment between braced and surgically treated patients are not well explored, this study aimed to determine whether short-term differences exist in HRQoL between adolescents treated with a brace or treated surgically. A cross-sectional analysis of HRQoL was made of 109 patients with adolescent idiopathic scoliosis who, after completing treatment, filled out the Dutch SRS-22 Patient Questionnaire. All patients had been treated either with a brace or surgery, or with a brace followed by surgery. Patients treated surgically had significantly higher mean scores in the satisfaction with management domain than those treated with a brace. No other consistent differences in HRQoL were found between patients treated with a brace and patients treated surgically. Gender, curve type and curve size had no relevant effect on HRQoL. We conclude that short-term differences in HRQoL after treatment in adolescent patients with idiopathic scoliosis are negligible and cannot support preference of one treatment above the other.
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- 2007
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200. The value of a pantaloon cast test in surgical decision making for chronic low back pain patients: a systematic review of the literature supplemented with a prospective cohort study.
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Willems PC, Elmans L, Anderson PG, Jacobs WC, van der Schaaf DB, and de Kleuver M
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- Adult, Female, Humans, Male, Lumbar Vertebrae surgery, Pain Measurement, Treatment Outcome, Casts, Surgical, Low Back Pain surgery, Spinal Fusion
- Abstract
The results of lumbar fusion in chronic low back pain (LBP) patients vary considerably, and there is a need for proper patient selection. Lumbosacral orthoses have been widely used to predict outcome, however, with little scientific support. The aim of the present study was to determine the value of a pantaloon cast test in selecting chronic LBP patients for lumbar fusion or conservative management. First, a systematic review of the literature was carried out in which two independent reviewers identified studies in Medline, Cochrane and Current Contents databases. Three papers met the selection criteria. In the only study with a control group, a significantly better outcome after fusion compared to conservative treatment was found in patients who reported significant pain relief while in a cast (i.e. a positive cast test). The results of lumbar fusion, however, were not significantly different for patients with a positive and those with a negative cast test. In addition to the review, a clinical cohort study of 257 LBP patients, who had been allocated to either lumbar fusion or conservative management by a temporary external transpedicular fixation trial, was performed. Prior to allocation, all had undergone a pantaloon cast test. Patients with no history of prior spine surgery and with a positive pantaloon cast test had a better outcome after lumbar fusion than those treated conservatively (P = 0.002, chi (2 )test). In patients with previous spine operations the outcomes were poor and the test was of no value. From the literature and the present patient cohort, it was concluded that only in chronic LBP patients without prior spine surgery, a pantaloon cast test with substantial pain relief suggests a favorable outcome of lumbar fusion compared to conservative management. The test has no value in patients who have had previous spine surgery.
- Published
- 2006
- Full Text
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