Real-world Experience and Patient Satisfaction with Local Osteo-enhancement Procedure (LOEP): An Open Label Study in Patients with High Fracture Risk

Introduction: The purpose of the research was to evaluate the safety and patient satisfaction of percutaneous local osteo-enhancement procedure (LOEP) utilizing a resorbable calcium-based implant material (AGN1) in bone voids in the hips of people with osteopenia or osteoporosis.

Methods: Retrospective, open-label, single-surgeon study of 43 adults with osteopenia or osteoporosis receiving AGN1 LOEP treatment of their proximal femurs (N=50 hips). Informed consent was obtained from all participants. Evaluations consisted of medical record review, including radiographs, pain and functional assessments, and a participant experience questionnaire. All subjects met at least one criterion for high or very high fracture risk based on BMD T-scores, fracture history, and fracture risk assessment (FRAX) scores.

Results: Post-operative DXA performed on average 397±216 days after LOEP indicated a mean femoral neck and total hip BMD (DXA) increased 25% and 28%, respectively ([Fig. 1]). Participants reported high satisfaction scores average 81.3±25.3 (maximum=100). In 25 of the 26 evaluable radiographs gathered during medical review, AGN1 resorption and regional bone formation was evident. Twenty-one adverse events (AEs) were recorded, eight of which were classified as serious adverse events (SAEs). 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.

Fig. 1  Femoral Neck and Total Hip BMD Abstract

Discussion: This real-world study supports the safety and patient satisfaction of AGN1 LOEP for treating bone voids associated with osteopenia and osteoporosis in the hip.

Keywords: Osteoporosis, LOEP, Local Osteo Enhancement Procedure, BMD, Fragility Fracture, AGN1, DXA, osteopenia

Korrespondenzadresse: Jo De Schepper, Vitaz St. Niklaas, Orthopedics, Moerlandstraat 1, 9100 St. Niklaas, Belgium, E-Mail: [e-mail]

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Artikel online veröffentlicht:
21. März 2025