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

Abstract

IntroductionPatients 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 analysisNinety-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 disseminationEthical 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 numberNL8746.

Similarities and Differences in the Management of Patients with Osteoporotic Vertebral Fractures and Those with Rebound-Associated Vertebral Fractures Following Discontinuation of Denosumab

“…In VFx, disproportionate height loss from the anterior vertebral body is common and results in wedging, which compromises the mechanical capacity of the spine to support daily activities and increases the loads on the anterior of the other vertebrae, thus predisposing patients to new VFx [ 37 , 38 ]. Conservative management with pharmacological and non-pharmacological interventions reduces symptoms and improves muscle flexibility and strength, but it does not decrease the anterior vertebral loading [ 38 , 39 ]. The latter can be reduced with bracing, which ensures a more upright posture that may prevent deterioration of the fracture configuration.…”

Bioactive mineralized small intestinal submucosa acellular matrix/PMMA bone cement for vertebral bone regeneration

“…Osteoporosis is a condition of the bones characterized by decreased bone density and compromised bone architecture, leading to a higher susceptibility to bone fractures [ 2 , 3 ]. The most prevalent form of fracture caused by osteoporosis is osteoporotic vertebral compression fracture (OVCF) [ 4 , 5 ], with ∼1.4 million new cases estimated each year globally [ 6 ]. OVCF is primarily characterized by severe low back pain, which can severely limit mobility, significantly diminish the patient’s quality of existence and even pose a risk of fatality [ 7 , 8 ].…”