Prospective, Post-market Evaluation of Safety and Efficacy of a Local Osteo- Enhancement Procedure (LOEP) in the Proximal Femur of Women in Europe with Osteoporosis
The research will be conducted as a prospective, post-market, multi-center study within Europe. The maximum number of subjects to be treated is 150 across up to 20 sites. This will be a non-randomized and open-label study. The study will collect procedural, short- and long-term data on the safety and clinical performance of AGN1 LOEP in the post-market setting in European countries where AGN1 LOEP is commercially available. AGN1 is intended to form new bone in voids in the proximal femur of women with osteoporosis.
• Subject is a postmenopausal female (at least 1-year post menses).
• Subject has bone loss in the hip attributable to osteoporosis as defined by a femoral neck DXA T-score of -2.5 or less.
• Subject has at least one hip without previous surgery or fracture.
• Subject is medically stable from any previous treatment or medical procedure in the opinion of the investigator and with an ASA score of I or II.
• Subject has willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study.
• Subject is capable of giving written informed consent to participate in the study.