Effectiveness and cost-effectiveness of dynamic bracing versus standard care alone in patients suffering from osteoporotic vertebral compression fractures: protocol for a multicentre, two-armed, parallel-group randomised controlled trial with 12 months of follow-up.

INTRODUCTION: Patients with osteoporosis may suffer from a fracture after minimal trauma. Osteoporotic vertebral compression fractures (OVCFs) are among the most common fractures, often leading to substantial pain. There is a need for evidence-based conservative treatment to aid in the management of OVCFs. The objective of this randomised controlled trial (RCT) is to evaluate the effectiveness and cost-effectiveness of dynamic bracing in addition to standard care for improving quality of life (QoL) in patients suffering from an OVCF. METHODS AND ANALYSIS: Ninety-eight postmenopausal women from two academic and four community hospitals with a recent symptomatic thoracolumbar OVCF will be randomised into either the standard care or dynamic bracing group. In the dynamic bracing group, the Spinova Osteo orthosis will be used in addition to standard care. Standard care comprises pain control with analgesics, physical therapy and osteoporosis medication. The primary outcome parameter is QoL 1 year after inclusion, as measured by the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO-41). Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life. A trial-based economic evaluation consisting of both cost-effectiveness analysis and cost-utility analysis will be performed based on empirical data obtained in the RCT. A process evaluation will assess the feasibility of dynamic bracing. All outcomes will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Medical Ethics Committee, University Hospital Maastricht and Maastricht University (METC azM/UM) (NL74552.068.20/METC 20-055). Patients will be included only after verification of eligibility and obtaining written informed consent. Results will be disseminated via the Dutch National Osteoporosis Patient Society and via publications and conferences. TRIAL REGISTRATION NUMBER: NL8746.

Implementation of patient-reported outcome measures in appropriateness criteria of surgery for degenerative lumbar scoliosis.

BACKGROUND CONTEXT: Degenerative lumbar scoliosis (DLS) is an increasingly common spinal disorder of which current management is characterized by a substantial variety in treatment advice. To improve evidence-based clinical decision-making and increase uniformity and transparency of care, the Scoliosis Research Society established appropriateness criteria for surgery for DLS. In these criteria, however, the patient perspective was not formally incorporated. Since patient perspective is an increasingly important consideration in informed decision-making, embedding patient-reported outcome measures (PROMs) in the appropriateness criteria would allow for an objective and transparent patient-centered approach. PURPOSE: To evaluate the extent that patient perspective is integrated into the appropriateness criteria of surgery for DLS. STUDY DESIGN: Single center, retrospective, cohort study. PATIENT SAMPLE: 150 patients with symptomatic degenerative lumbar scoliosis. OUTCOME MEASURES: The association between appropriateness for surgery and various PROMs [Visual Analogue Scale for pain, Short Form 36 (SF-36), Pain Catastrophizing Scale (PCS), Hospital Anxiety Depression Scale (HADS), and Oswestry Disability Index (ODI)]. METHODS: Medical records of all patients with symptomatic DLS were reviewed and scored according to the appropriateness criteria. To assess the association between the appropriateness criteria and the validated PROMs, analysis of variance was used to test for differences in PROMS for each of the three categories resulting from the appropriateness criteria. To assess how well PROMs can discriminate between appropriate and inappropriate, we used a logistic regression analysis. Discriminative ability was subsequently determined by computing the area under the curve (AUC), resulting from the logistic regression analysis. Spearman rank analysis was used to establish a correlation pattern between the PROMs used and the appropriateness criteria. RESULTS: There was a significant association between the appropriateness of surgery and the PROMs. The discriminative ability for appropriateness of surgery for PROMs as a group was strong (AUC of 0.83). However, when considered in isolation, the predictive power of any individual PROMs was poor. The different categories of the appropriateness criteria significantly coincided with the PROMs used. CONCLUSION: There is a statistically significant association between the appropriateness criteria of surgery for DLS and PROMs. Implementation of PROMs into the appropriateness criteria may lead to more transparent, quantifiable and uniform clinical decision making for DLS.

Prediction of mechanical complications in adult spinal deformity surgery-the GAP score versus the Schwab classification.

BACKGROUND CONTEXT: Surgery for adult spinal deformity is a challenging and complex procedure with high reported complication (8.4%-42%) and revision rates (9%-17.6%). Failure to achieve or maintain adequate postoperative sagittal alignment has been reported to be the main cause of mechanical complications. In order to define appropriate surgical targets, the Scoliosis Research Society-Schwab classification and the Global Alignment and Proportion (GAP) score were established. In the literature, no study has yet compared these classification systems with respect to the risk of developing mechanical complications. PURPOSE: To assess and compare the ability of the Schwab classification and the GAP score to predict mechanical complications following adult spinal deformity surgery. STUDY DESIGN: Two-center, retrospective cohort study. PATIENT SAMPLE: Thirty-nine patients suffering adult spinal deformity who underwent long segment spinal fusion (≥4 levels), minimum follow-up of 2years. OUTCOME MEASURES: The ability of the Schwab classification and GAP score to predict mechanical failure was determined by computing the Area Under the receiver operating characteristic curve. METHODS: Full-spine pre- and postoperative radiographs of all patients were analyzed for mechanical complications. Subsequently, the pre- and postoperative Schwab and GAP score were determined. Logistic regression analysis was used to assess the ability of both systems to determine which was the most appropriate for the prediction of mechanical failure. Correlations between the various factors constituting the GAP score and Schwab classification were estimated using the Spearman rank order correlation coefficient. RESULTS: The results demonstrated that both classification systems are capable of predicting radiographic evidence of mechanical failure; however, the GAP score proved to be significantly better (p=.003). The relative pelvic version of the GAP score serves a similar role as the pelvic tilt modifier from the Schwab classification (ρ=-0.84, p<.01). The relative lumbar lordosis from the GAP score functions much like the PI-LL modifier from the Schwab classification (ρ=-0.94, p<.01). The GAP score is most significantly dependent on relative spinopelvic alignment, relative lumbar lordosis, and relative pelvic version (ρ=0.85, ρ=0.84, and ρ=0.84, respectively, p<.01). Correlation with the lordosis distribution index was also significant but was not as strong (ρ=0.65, p<.01). Age, on the contrary, showed poor correlation with the GAP score (ρ=0.17, p=.300). CONCLUSIONS: Both the Schwab classification and the GAP score are capable of predicting mechanical complications. The GAP score proved to be significantly more appropriate. This difference is probably attributed to the fact that in the GAP score all parameters are related to the patient's individual pelvic incidence.