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

Inclusion Criteria:

1. Provision of signed and dated informed consent form prior to any study procedures

2. Stated willingness to comply with all study procedures and availability for theduration of the study

3. Skeletally mature males and females

4. 1 painful VCF which meets all of the following criteria:

5. Fracture due to diagnosed or presumed underlying osteoporosis (T-score < -2.5points)

6. VCF between T6 and L5

7. VCF shows loss of height in the anterior, mid or posterior third of thevertebral body from an estimated pre-fracture configuration, but no more than 50% based on X-ray, CT or MRI at baseline.

8. The Index fracture is acute or persistent (not healed), as demonstrated by MRI (or bone scan if the patient is contraindicated for MRI).

9. 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: .

1. Patient presenting a loss of vertebral height >50% compared to estimatedpre-fracture height

2. Sclerotic fracture

3. Patient with a prior history of intolerance or of allergic reaction to titaniumand/or one of the components of the PMMA cement

4. Patient suffering from irreversible coagulopathy or undergoing anticoagulanttreatment at the moment of surgery or at least 8 days prior to inclusion

5. Active infection (systemic or in the target vertebra)

6. Patient suffering from a severe or uncontrolled systemic disease

7. Patient presenting a pathological fracture with the presence of a mass within thespinal canal

8. Patient presenting neurological damage caused by vertebral fracture

9. Patient pregnant or likely to be so or breastfeeding

10. Patient vertebral anatomy not compatible with the size of the implant orinstrumentation

11. Fracture geometry making the insertion of the implant impossible