RESTORE (AGN-CIP-100)
Research type
Research Study
Full title
Randomized Controlled Study of a Local Osteo-Enhancement Procedure (LOEP) to Prevent Secondary Hip Fractures in Osteoporotic Women Undergoing Treatment of Index Hip Fractures
IRAS ID
283203
Contact name
Stephanie Kladakis
Contact email
Sponsor organisation
AgNovos Healthcare USA, LLC
Duration of Study in the UK
6 years, 8 months, 1 days
Research summary
The RESTORE study is an event driven, randomized, controlled, prospective, single blinded, multi-national study. The study is designed to demonstrate the safety and effectiveness of the AGN1 LOEP treatment for decreasing the likelihood of secondary hip fractures in women presenting with an index hip fracture and undergoing hip fracture repair surgery. In addition, to qualify for the study, a patient must be eligible for AGN1 LOEP based on the currently approved indications for use. Following the repair of the subject’s hip fracture, they will be randomized into either the treated or control group. In the treated group, the second hip will be treated by injecting a manmade bone implant material (AGN1), which is comprised of a mixture of calcium phosphates and calcium sulfate. In the control group, they will not receive the AGN1 LOEP treatment.
The CE-marked AGN1 LOEP Kit contains the AGN1 resorbable implant material, which is intended to form new bone in voids in the skeletal system with the proximal femur as area of interest for this study. This new bone increases the bone density and strength of the proximal femur and this increase in strength is expected to reduce hip fracture risk for patients treated with AGN1 LOEP.
For the study, subjects will visit the hospital seven times over 5 years. In between the hospital visits, subjects will be contacted by phone for follow up. Study specific assessments include physical exams, hip imaging by X-ray and DXA scans, questions about the subjects’ recent medical history and the completion of questionnaires about the subjects’ health status.
Hypothesis testing will be conducted after 56 subjects experience a secondary hip fracture event, unless the study is stopped early as a result of the interim analysis, which will be conducted after 28 subjects experience a secondary hip fracture event.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0272
Date of REC Opinion
14 Jan 2021
REC opinion
Further Information Favourable Opinion