Immediate Contralateral Local Osteo-enhancement of the Hip in Postmenopausal Women with Fragility Hip Fracture : Early Interim Results of a Prospective Study

Abstract

Introduction: Hip fractures are common fragility fractures and are associated with significant morbidity and mortality. Patients with a first hip fracture are at high risk of contralateral hip fracture within 1 year. The AGN1 local osteoenhancement procedure (LOEP) is a novel intervention that may help prophylactically reduce the risk of contralateral hip fracture. This study aimed to evaluate the feasibility and safety of performing LOEP on the contralateral hip in the same operative session for a first-time fracture. Methods: This is a prospective single-arm cohort study of 20 patients. Each patient underwent repair of the fractured hip followed by treatment of the contralateral hip with LOEP in the same operative session. The primary endpoint was the incidence of all serious adverse events occurring from the day of procedure through the 24-month follow-up period related to femoral LOEP. The secondary endpoints were the incidence of fragility fractures occurring during the follow-up period; all adverse events related to LOEP; and serial evaluation of bone mineral density post-procedure. Results: No adverse events were directly related to the device or procedure. There was no increase in perioperative complications, length of stay, or time to weightbearing. No patients experienced fractures, pain or discomfort at the injected hip. By 12 months, the AGN1 core was replaced by new bone integrated with surrounding host bone. Conclusion: The preliminary data at 12 months support the feasibility of AGN1 LOEP as a concomitant treatment of the contralateral hip in patients with a first hip fracture.