IRB Study Number WIRB20214491
Status Recruiting
Phase Not Applicable
Location Tradition HealthPark One
Institute Neurological Institute
Description
This is a multicenter, single-blinded, randomized controlled clinical trial evaluating the safety and efficacy of the AGN1 LOEP SV Kit for the treatment of painful vertebral compression fragility fractures (VCFs). The objective of this study is to demonstrate non-inferiority of the AGN1 LOEP SV Kit for the treatment of VCFs to standard of care vertebroplasty treatment using bipedicular injection of PMMA bone cement.
Inclusion Criteria
- Subject is a male or female 50 years of age or older at time of study treatment.
- Subject has one (1) or two (2) acute VCF. Note that subjects are eligible if they have an asymptomatic, chronic VCF(s) at any non-target, nonadjacent vertebral level.
- The acute VCF meets all of the following criteria: a. Due to diagnosed or presumed underlying osteoporosis ; b. T1 to L5 inclusively; c. Target VCF-related pain < 6 months at time of study treatment.
- Each target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
- 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.
- Focal tenderness to palpation of the spinal process of each target VCF on the physical exam correlates with imaging.
- 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.
- Subject has an Oswestry Disability Index (ODI) score of ≥ 30% at baseline.
- Subject is capable of giving written informed consent to participate in the study.
- 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
- At least one of the target VCF is unstable, including split or burst fracture.
- Subject has a bleeding disorder.
- Subject has an active infection of the spine or surgical site.
- Target VCF is due to underlying or suspected tumor.
- Target VCF is due to high-energy trauma.
- Target VCF is due to osteonecrosis.
- Subject has had any prior surgical treatment at the target vertebral level or adjacent vertebral levels.
- Subject has a history of invasive malignancy within the last five (5) years, other than nonmelanoma 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.
- Subject has uncontrolled diabetes mellitus.
- Subject has severe renal insufficiency defined as an estimated glomerular filtration rate (eGFR) < 30 mL/min.
- Subject has a diagnosed calcium metabolism disorder
