STAND - Study of the AGN1 LOEP SV Kit Compared to PMMA in Patients with Vertebral Compression Fractures

Launched by AGNOVOS HEALTHCARE, LLC · Apr 5, 2021

Keywords

ClinConnect Summary

The STAND trial is studying a new treatment called the AGN1 LOEP SV Kit for people with painful vertebral compression fractures (VCFs), which are breaks in the spine often caused by osteoporosis. This trial compares the safety and effectiveness of this new kit to a standard treatment called vertebroplasty, where a type of bone cement is injected into the spine to help relieve pain. The goal is to see if the new treatment works just as well as the standard one.

To participate, individuals need to be 50 years or older and have one or two recent VCFs that are causing pain. They should have already tried other treatments, like rest or physical therapy, without success. Participants will receive either the new treatment or the standard treatment and will be monitored for their progress. It's important to note that there are specific criteria that could make someone ineligible, such as having certain medical conditions or complications related to their fractures. If you think you might qualify, speaking with your doctor could be a good first step.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is a male or female 50 years of age or older at the time of study treatment.
• • 2. Subject has one (1) or two (2) acute VCF(s). Note that subjects are eligible if they have an asymptomatic, healed VCF(s) at any non-target vertebral level.
• 3. Each target VCF meets all of the following criteria:
• • 1. Due to diagnosed or presumed underlying osteoporosis
• • 2. T1 to L5 inclusively
• • 3. Target VCF-related pain ≤ 6 months at time of study treatment
• • 4. Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
• • 5. Each target VCF is acute or persistent (not healed), as demonstrated on imaging, including T2-weighted, STIR MRI, bone scan or bone scan with SPECT/CT, serial radiographs, or other serial imaging demonstrating acuity.
• • 6. Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
• • 7. Subject has failed conservative medical therapy (bed rest, observation, chiropractic care, orthotics, opioid and non-opioid analgesics, and/or physical therapy), defined as either having a VAS back pain score of ≥ 70 mm after 24 hours to 6 weeks of conservative care or a VAS back pain score of ≥ 50 mm after more than 6 weeks of conservative care.
• • 8. Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
• • 9. Subject is capable of giving written informed consent to participate in the study.
• • 10. The subject's willingness, ability, and commitment to participate in screening, treatment, and all follow-up evaluations for the full length of the study has been documented
• Exclusion Criteria:
• • 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.