NCT04796350

RESTORE - Study of AGN1 LOEP to Prevent Secondary Hip Fractures

Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: AgNovos Healthcare, LLC · Industry
• Sex: Female
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial to evaluate AGN1 to prevent secondary hip fractures in osteoporotic women undergoing treatment of index hip fractures. Up to 2400 subjects will be randomized between a treatment group and a control group. Subjects will be followed for a minimum of 5 years after undergoing hip fracture repair surgery.

Detailed description

This is an event driven, randomized, controlled, prospective, single blinded (non-blinded in Canada), multi-national study. This study is designed to demonstrate that the AGN1 LOEP treatment can reduce the incidence of secondary hip fractures in subjects presenting with an index hip fracture and undergoing hip fracture repair surgery. Subjects presenting with an index fragility hip fracture who will undergo hip fracture repair will be enrolled. Subjects will be randomized 1:1 into the following two study groups: 1. Treated Group - receives standard of care to repair the index hip fracture and AGN1 LOEP treatment on the target unfractured contralateral hip 2. Control Group - receives standard of care to repair the index hip fracture and no AGN1 LOEP treatment on the target unfractured contralateral hip AGN1 LOEP is an elective procedure that will be performed immediately following hip fracture repair. Subjects will be followed through scheduled visits conducted at 6 weeks, 6 months, and every 6 months thereafter for a minimum of 5 years.

Conditions

• Fragility Fracture
• Hip Fractures
• Osteoporosis

Interventions

Type	Name	Description
DEVICE	AGN1 LOEP treatment	the implantation site is injected with the AGN1 implant material

Timeline

• Start date: 2021-04-24
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2021-03-12
• Last updated: 2025-09-16

Locations

54 sites across 10 countries: Austria, Canada, Denmark, France, Germany, Italy, Japan, Netherlands, Spain, United Kingdom