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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.
Full description
Four hundred and eight (408) eligible subjects at up to twenty-five (25) study sites will be randomized 1:1 for treatment using the AGN1 LOEP SV Kit (Intervention Group) or PMMA bone cement (Active Control Group).
Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure.
Enrollment
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Inclusion criteria
Subject is a male or female 50 years of age or older at the time of study treatment.
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.
Each target VCF meets all of the following criteria:
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
Primary purpose
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Interventional model
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408 participants in 2 patient groups
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Central trial contact
Allison Gorman
Data sourced from clinicaltrials.gov
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