Dynamic bracing for OVCFs
Recruiting
- Conditions
- Osteoporotic vertebral compression fractures (OVCFs)
- Registration Number
- NL-OMON24180
- Lead Sponsor
- Bauerfeind
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 98
Inclusion Criteria
Postmenopausal women;
- A symptomatic thoracolumbar osteoporotic vertebral compression fracture (less than 6 weeks old);
- Eligible for questionnaires with sufficient understanding of the Dutch written language.
Exclusion Criteria
- Unstable vertebral fractures amenable for operative treatment;
- Neurologic deficit;
- Severe spinal deformity (scoliosis);
- Infection;
- Active cancer;
- Psychiatric or mental disease;
- Insufficient cognitive or language skills to complete the questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome parameter is quality of life at one year after intervention. This will be measured using the Quality of Life Questionnaire of the European Foundation for Osteoporosis (Qualeffo-41).
- Secondary Outcome Measures
Name Time Method Secondary outcome parameters are pain, pain medication used, functional disability, sagittal spinal alignment, recurrence rate of OVCFs and physical activity in daily life.<br>Static sagittal alignment and recurrence fracture rate will be analyzed on standardized lateral full-spine radiographs using validated software. For patients included in the Maastricht University Medical Center gait quality and postural balance will be assessed using the computer-assisted rehabilitation environment (CAREN, Motek-force Link). Physical activity and gait speed in daily life will be assessed with the MOX activity monitor.