High Satisfaction Post Local Osteo-enhancement Procedure (LOEP): An Open Label Study in Patients with High Fracture Risk

Purpose To evaluate percutaneous local osteo-enhancement procedure (LOEP) using resorbable calcium-based AGN1 implant in hip bone voids of individuals with osteopenia or osteoporosis. Methods Retrospective, open-label, single-surgeon study of adults with osteopenia or osteoporosis treated with AGN1 LOEP between September 2019 and November 2022. Eligible participants were previously treated with LOEP, willing to participate, and able to give written informed consent. Evaluations consisted of medical record review including pain and functional assessments, and a participant experience questionnaire. 40 women and 3 men treated for bone voids related to osteoporosis/osteopenia participated, all of whom met ≥1 criteria for high (n = 3) or very high (n = 40) fracture risk based on bone mineral density (BMD) T-scores, fracture history, and fracture risk assessment (FRAX®) scores. LOEP was performed on 50 hips, comprising 36 participants treated unilaterally and 7 bilaterally. Participants had a mean follow-up period of 397 days post-LOEP. Results DXA indicated mean increases in total hip and femoral neck BMD of 25-28% from baseline after a mean follow-up period of 397 days. Radiographs obtained an average of 311 days post-LOEP indicated AGN1 implant material was in resorption process, with radiographic evidence of regional bone formation in 25 of 26 available radiographs. Function and pain scores numerically improved in most participants after LOEP, and participants generally reported high satisfaction with LOEP (median satisfaction score, 87.0/100). Eight adverse events related to the device or procedure were observed in a total of 43 participants (18.6%). These events were categorized as mild and related to wound complications (pain, bruising, seroma) or implant material leakage. Four of the eight events were device related and consisted of discomfort, localized pain, and material leakage. Conclusions This real-world study supports the safety of, and satisfaction with, AGN1 LOEP for the treatment of local bone loss in the hip associated with osteopenia or osteoporosis.