Clareo Health | STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients With Vertebral Compression Fractures

1. At least one of the target VCF(s) is unstable, including split or burst fracture.

2. Subject has a bleeding disorder.

3. Subject has an active infection of the spine or surgical site.

4. Subject has a bloodborne infection.

5. At least one of the target VCFs is due to underlying or suspected tumor.

6. At least one of the target VCFs is due to high-energy trauma.

7. At least one of the target VCFs is due to osteonecrosis.

8. At least one of the target VCFs has a local kyphotic angle of \> 30 degrees, measured as the angle between the superior endplate and inferior endplate at the target VCF.

9. Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.

10. The pedicle(s) in the target vertebral body appears unable to safely accommodate transpedicular access instrumentation.

11. Subject has neurologic symptoms, deficits, or radiculopathy related to the target VCF(s).

12. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.

13. Subject has pain, progressive weakness, or paralysis due to herniated nucleus pulposus or spinal stenosis.

14. Subject has spondylolisthesis \> Grade 1 at target vertebral body(ies).

15. Subject requires daily opioid medication for pain not related to the target VCF(s).

16. Subject has severe cardiopulmonary deficiencies.

17. Subject has a Body Mass Index (BMI) \> 35.

18. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).

19. Subject has a history of tuberculous spondylitis.

20. Subject has a history of invasive malignancy within the last five (5) years, other than non-melanoma skin cancer. Subject is not excluded if they have a history of malignancy over 5 years ago treated with curative intent and without clinical signs or symptoms since then.

21. Subject is on oral or parenteral immune-suppressive drugs.

22. Subject has uncontrolled diabetes mellitus.

23. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min.

24. Subject has a diagnosed calcium metabolism disorder.

25. Subject has known allergies to calcium-based bone void fillers.

26. Subject is pregnant or planning to become pregnant during participation in the study.

27. In the judgment of the Investigator, the subject is not a good study candidate. (e.g. substance abuse or chemical dependency, inability to adhere to follow-up schedule, progression of the fracture between screening and the procedure visit).

28. Subject is currently enrolled in another interventional clinical study.

What this study is about