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

Vertebral Compression Fracture Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial 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). 1. Intervention Group - receives vertebral augmentation of the target VCF(s) using the AGN1 LOEP SV Kit 2. Active Control Group - receives vertebral augmentation of the target VCF(s) using either Stryker VertaPlex HV or Medtronic Kyphon HV-R. Follow-up visits will be conducted at 7 days, 28 days, 3 months, 12 months and 24 months after the procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04835428
Study type Interventional
Source AgNovos Healthcare, LLC
Contact Allison Gorman
Phone 2407536424
Email agorman@agnovos.com
Status Recruiting
Phase N/A
Start date May 31, 2022
Completion date December 31, 2027
View Details
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