NCT04835428

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vertebral Compression Fracture
• Compression Fracture
• Vertebral Compression

Interventions

Type	Name	Description
DEVICE	Treatment Group: AGN1 LOEP SV Kit	The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.
DEVICE	Control Group: PMMA bone cement	High viscosity PMMA bone cement will be used for vertebral augmentation.

Timeline

• Start date: 2022-05-31
• Primary completion: 2025-12-31
• Completion: 2027-12-31
• First posted: 2021-04-08
• Last updated: 2025-09-16

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study