Evaluation of a new treatment for painful vertebral compression fractures

A Prospective Multi-Center Study of the AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit in Patients With Vertebral Compression Fractures (VCFs)

This study is testing a new treatment for painful vertebral compression fractures to see if it is safe and effective for people suffering from this condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: AgNovos Healthcare, LLC (Industry-sponsored)
• Locations: 4 sites (Frankfurt, Hessen and 3 other locations)
• Trial ID: NCT04821739 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, single-arm, multi-center study aimed at assessing the safety and clinical performance of the AGN1 LOEP SV Kit in treating painful vertebral compression fractures (VCFs). A total of 100 subjects will be enrolled across 10 sites in Europe, with follow-up visits scheduled at various intervals up to 24 months post-treatment. The study will be conducted in three stages, starting with a small group to evaluate safety before expanding to a larger cohort to assess both safety and performance.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 50 and older with a recent acute vertebral compression fracture due to osteoporosis.

Not a fit: Patients with multiple vertebral compression fractures or those whose fractures are older than six months may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients suffering from vertebral compression fractures.

How similar studies have performed: While this approach is novel, similar studies evaluating new treatments for vertebral compression fractures have shown promise in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

1. Subject is a male or female 50 years of age or older at time of study treatment.
2. Criterion omitted
3. Subject has only one (1) acute VCF. Subjects are eligible if they have an asymptomatic healed VCF at any non-target vertebral level.
4. This VCF meets all of the following criteria:

   1. Fracture due to diagnosed or presumed underlying osteoporosis
   2. VCF from T1 to L5 inclusive
   3. Fracture age ≤6 months at time of treatment
5. Target VCF shows loss of height in the anterior or middle portion of the vertebral body of not more than 50% based on X-ray at baseline.
6. Target VCF is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI, bone scan, CT, serial radiographs, or other imaging demonstrating acuity.
7. Subject has central pain upon palpation over the spinal process at the target vertebral body.
8. Subject has failed conservative medical 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 6 weeks of conservative care.
9. Subject has an Oswestry Disability Index (ODI) score of ≥ 30%.
10. Subject is capable of giving written informed consent to participate in the study.
11. 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. Target VCF is due to underlying or suspected tumor.
2. Target VCF is due to high-energy trauma.
3. Target VCF is diagnosed as an osteonecrotic fracture.
4. Target VCF has segmental kyphosis of \> 30°.
5. Target VCF is unstable including split or burst fractures.
6. Subject has had any prior surgical treatment at the target VCF or adjacent vertebral level (above or below VCF).
7. Subject has neurologic symptoms, deficits, or radiculopathy related to the VCF.
8. Subject has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated.
9. Subject has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis).
10. Subject has spondylolisthesis \> Grade 1 at target vertebral body.
11. Subject has pain due to any other condition that requires daily narcotic medication.
12. Subject has severe cardiopulmonary deficiencies.
13. Subject has a bleeding disorder.
14. Subject has a Body Mass Index (BMI) \> 35.
15. Subject has a history of metabolic bone disease other than osteoporosis (e.g., Paget's disease, renal osteodystrophy, or osteomalacia).
16. Subject has a history of tuberculosis spondylitis.
17. Subject has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for five (5) years.
18. Subject is on oral or parenteral immune-suppressive drugs.
19. Subject has an active bone infection at target VCF.
20. Subject has uncontrolled diabetes mellitus, as determined by the judgment of the Investigator.
21. Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) \< 30 mL/min.
22. Subject has a diagnosed calcium metabolism disorder.
23. Subject has known allergies to calcium-based bone void fillers.
24. Subject is pregnant or planning to become pregnant during participation in the study.
25. In the judgment of the Investigator, the subject is not a good study candidate (e.g., inability to maintain follow-up schedule, comorbidity or poor general physical/mental health, or drug or alcohol abuse issues).
26. Subject is currently enrolled in another interventional clinical study.

Where this trial is running

Frankfurt, Hessen and 3 other locations

• Orthopedic University Hospital Friedrichsheim — Frankfurt, Hessen, Germany (Withdrawn)
• Sana Klinikum Offenbach GmbH — Offenbach, Germany (Recruiting)
• Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)
• Hospital Clinico Universitario de Valladolid — Valladolid, Spain (Recruiting)

Study contacts

• Principal investigator: Mohammad Arab Motlagh, MD — Sana Klinikum Offenbach GmbH
• Study coordinator: Adam Lowe

Conditions Vertebral Compression Fracture; Vertebral Compression; Vertebral Fracture; LOEP; AGN1; RISE; Local Osteo-Enhancement Procedure