A Prospective Multicenter Clinical Investigation Evaluating the Safety and Efficacy of the VCFix Spinal System in Stand-alone Configuration for Vertebral Augmentation (EXPAND)
This study is being conducted to evaluate the safety and performance of the VCFix Spinal System, a medical device designed to treat certain types of spinal fractures called vertebral compression fractures (VCFs) in adults. Up to 8 hospitals in Europe will take part in the study. All participants will receive treatment with the VCFix device. The treatment will be provided according to the intended use of the device and may be performed either with or without the use of a special bone cement. Participants will be assigned to one of two study groups before treatment: Cementless group: the VCFix device is implanted without bone cement. Cemented group: the VCFix device is implanted together with bone cement. The study will assess how well the treatment works and how safe it is. Researchers will evaluate: Changes in back pain 6 months after treatment compared with before treatment. Changes in daily functioning and ability to perform everyday activities 6 months after treatment compared with before treatment. Whether any serious device-related complications occur during the first month after treatment. The results will help determine whether treatment with the VCFix device provides benefits for patients with vertebral compression fractures while maintaining an acceptable safety profile.
• Subject is ≥ 21 to ≤ 85 years old.
• Single vertebral fracture which meets all of the following criteria:
‣ Type A fractures from AO spine classification (compression injuries);
⁃ Vertebral fracture located in the thoracic and lumbar regions of the spine
⁃ Fracture age \< 6 weeks or fractures with anatomic signs of reducibility (based on radiographic evidence as well as patient history)
⁃ Vertebral fracture shows an estimated height loss in the anterior or mid third of the vertebral body (VB) of at least 10% but not more than 60% based on radiographic evidence
⁃ Target VB has appropriate anatomy, i.e. suitable pedicle diameter, pedicle length and chord length that would allow for selection of correct implant size, as described in the IFU and based on axial MRI/CT scan before surgery
• 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