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.

Optimization and Validation of a Classification Algorithm for Assessment of Physical Activity in Hospitalized Patients.

Low amounts of physical activity (PA) and prolonged periods of sedentary activity are common in hospitalized patients. Objective PA monitoring is needed to prevent the negative effects of inactivity, but a suitable algorithm is lacking. The aim of this study is to optimize and validate a classification algorithm that discriminates between sedentary, standing, and dynamic activities, and records postural transitions in hospitalized patients under free-living conditions. Optimization and validation in comparison to video analysis were performed in orthopedic and acutely hospitalized elderly patients with an accelerometer worn on the upper leg. Data segmentation window size (WS), amount of PA threshold (PA Th) and sensor orientation threshold (SO Th) were optimized in 25 patients, validation was performed in another 25. Sensitivity, specificity, accuracy, and (absolute) percentage error were used to assess the algorithm's performance. Optimization resulted in the best performance with parameter settings: WS 4 s, PA Th 4.3 counts per second, SO Th 0.8 g. Validation showed that all activities were classified within acceptable limits (>80% sensitivity, specificity and accuracy, ±10% error), except for the classification of standing activity. As patients need to increase their PA and interrupt sedentary behavior, the algorithm is suitable for classifying PA in hospitalized patients.