Post-Market Study of The Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures

This study is a prospective, multicenter, open-label, single-arm, PMCF study. The sample size for this study will be 50 patients. Eligible patients will be treated with Tripod-Fix on Day 0 and will be followed for a total of 12 months.

Inclusion criteria

• Provision of signed and dated informed consent form prior to any study procedures
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Skeletally mature males and females
• 1 painful VCF which meets all of the following criteria:

• Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5 points)
• VCF between T6 and L5
• VCF shows loss of height in the anterior, mid or posterior third of the vertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.
• The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).
• Investigator believes target vertebral body is suitable for Tripod-Fix procedure (e.g., appropriate pedicle diameter) assessed on radiography preoperative.

Exclusion criteria

Tripod-Fix is not indicated for any other application other than that for which it is designed. contraindications for Tripod-Fix include, but are not limited to: .

• Patient presenting a loss of vertebral height >50% compared to estimated pre-fracture height
• Sclerotic fracture
• Patient with a prior history of intolerance or of allergic reaction to titanium and/or one of the components of the PMMA cement
• Patient suffering from irreversible coagulopathy or undergoing anticoagulant treatment at the moment of surgery or at least 8 days prior to inclusion
• Active infection (systemic or in the target vertebra)
• Patient suffering from a severe or uncontrolled systemic disease
• Patient presenting a pathological fracture with the presence of a mass within the spinal canal
• Patient presenting neurological damage caused by vertebral fracture
• Patient pregnant or likely to be so or breastfeeding
• Patient vertebral anatomy not compatible with the size of the implant or instrumentation
• Fracture geometry making the insertion of the implant impossible