A Randomized, Single-Blinded, Non-Inferiority Study Comparing AGN1 Local Osteo-Enhancement Procedure (LOEP) SV Kit Treatment of Vertebral Compression Fragility Fractures to PMMA Bone Cement Treatment
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.
• Subject is a male or female aged 55 and 85 years, inclusive, of age at time of study treatment.
• Subject has only one (1) acute VCF. Note that subjects are eligible if they have an asymptomatic, chronic VCF(s) at any non-target, non-adjacent vertebral level.
• The acute VCF meets all of the following criteria:
• Due to diagnosed or presumed underlying osteoporosis
• T1 to L5 inclusively
• Target VCF-related pain < 12 weeks at time of study treatment
• Target VCF shows loss of height of the vertebral body ≤ 50% based on X-ray at baseline.
• 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 the 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.