A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of V… (NCT07301749) | Clinical Trial Compass
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A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression Fractures.
France, Germany103 participantsStarted 2025-11-04
Plain-language summary
The primary objective of the EXPAND clinical investigation is to evaluate the safety and efficacy of the VCFix Spinal System for the treatment of Vertebral Compression Fractures. The study aims to demonstrate a reduction in vertebral fracture-related pain and an improvement in physical function and mobility, while ensuring the absence of (serious) adverse events ((S)AE) related to the device or procedure.
Who can participate
Age range21 Years – 85 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 21 to ≤ 85 years old.
✓. Single vertebral fracture which meets all of the following criteria:
✓. Subject has a NPRS back pain score of ≥5
✓. Subject is a candidate for surgical intervention based on investigator opinion
✓. Subject has a body Mass Index (BMI) \< 35
✓. Subject is mentally capable of complying with trial protocol requirements for the duration of the study
✓. Subject can understand the risks and benefits of participating in the study and is able to provide written informed consent
Exclusion criteria
✕. Neoplasms with posterior involvement and/or presence of a mass within the spinal canal
✕. Non-mobile fractures (i.e., fracture is not recent (\>6 weeks), bone marrow edema or fluid or empty cleft are not visible in radiographic imaging, or fracture mode does not allow for fracture reduction in craniocaudal direction).
✕. Spondylolisthesis \> Grade 1 at target vertebral body(s)
✕. Local kyphotic angle \> 30°
✕. Pre-existing vertebral fracture prior to the index fracture
✕. Subjects that require anterior stabilization of the index fracture
What they're measuring
1
Reduction of more than 2 points in vertebral fracture-related pain intensity at 6 months after the index procedure compared to baseline as measured by a 11-point Numerical Pain Rating Scale (NPRS)
Timeframe: 6 months
2
Maintenance or improvement of function as measured by the 100-point Oswestry Disability Index (ODI) at 6 months compared to baseline
Timeframe: 6 months
3
Absence of serious adverse device effects (SADEs): No SADEs with causality rated as definite, monitored through 1 month post-procedure (safety)