Mechernich

Researchers are evaluating the safety and effectiveness of the VCFix Spinal System for treating Vertebral Compression Fractures. The study aims to reduce pain related to vertebral fractures and improve physical function and mobility, while ensuring no serious adverse events related to the device or procedure occur. This clinical investigation focuses on a device designed to realign and stabilize fractured vertebrae with potential benefits over traditional bone cement methods. The VCFix Spinal System is a device that can be adjusted in place to restore vertebral height and correct spinal alignment. It features a titanium structure that supports natural bone healing and may provide better stability without the use of bone cement. The device also connects the front and back parts of the spine to improve load distribution and support more severe fractures. Participants receive this device in a stand-alone configuration as part of the treatment. Participants will be monitored for changes in pain intensity using an 11-point pain scale and physical function using the Oswestry Disability Index over 6 months. Safety is closely observed, particularly for serious adverse device effects within the first month after treatment. The study includes assessments of pain, function, and adverse events to evaluate the overall impact of the VCFix system. The study involves adults aged 21 to 85 with specific types of vertebral fractures suitable for this treatment.