Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment

Exclusion Criteria

• •1. Target VCF due to high-energy trauma or underlying/suspected tumor.
• •2. Target VCF is diagnosed as an osteonecrosis.
• •3. Segmental kyphosis of target vertebral compression \> 30°.
• •4. Any prior surgical treatment for a VCF or other surgical procedure on the target vertebral body or adjacent level.
• •5. The patient has uncontrolled systemic diabetes (A1c \> 10) and /or uncontrolled hypertension (patient requiring 3 or more anti-hypertensive drugs).
• •6. Pre-existing or clinically unstable neurologic deficit.
• •7. Spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
• •8. Any physical exam evidence of myelopathy, radiculopathy, or coagulopathy.
• •9. Disabling back pain due to causes other than acute fracture, or any other condition that requires daily narcotic medication, such as clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
• •10. Patient not able to walk without assistance prior to fracture.
• •11. Any radiographic evidence of cortical disruption, burst fractures and pedicle fracture.
• •12. Translation \> 4 mm or Spondylolisthesis \> Grade 1 at target vertebral body.
• •13. Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.).
• •14. In the investigator's opinion, a patient with any other medical illness or condition which may not be suitable to participate in the study, including but not limited to: A medical contraindication to spinal surgery and/or general anesthesia, such as Patients on chronic anti-coagulation. (Patients stop the treatment 8 days before surgery with a threshold for normal being INR \< 1.1 and platelets \> 100,000 are not limited to this.)
• •15. Prior history of intolerance or allergic reaction to titanium and/or one of the components of the PMMA cement.
• •16. Active systemic or local infection at baseline.
• •17. Body mass index \> 40.
• •18. Patients affected by severe cardiopulmonary deficiencies.
• •19. In the investigator's opinion, a patient with any other medical illness or condition which may not be suitable to participate in the study, including but not limited to: Likely to impair long-term follow-up (e.g., cancer).
• •20. Any evidence of alcohol or drug abuse.
• •21. Uncontrolled psychiatric disorders are defined by the DSM V or severe dementia.
• •22. Currently on anti-cancer therapy or anti-HIV therapy.
• •23. Life expectancy is less than the study duration or undergoing palliative care.
• •24. Participating in any other investigational study.
• •25. On long-term steroid therapy (steroid dose ≥ 30 mg /day for \> 3 months).
• •26. Known to be involved in spinal litigation.
• •27. Pregnant women as confirmed by positive pregnancy test or considering getting pregnant during study participation.
• •28. Presenting loss of vertebral height \> 50% compared to estimated pre-fracture height.
• •29. Interspinous-process widening.
• •30. Sclerotic fracture or pseudarthrosis.
• •31. Patient is a prisoner or not in the wards of the court.
• •32. Patients with contraindications to MRI and bone scan.