gms | German Medical Science

Objectives: AGN1 Local Osteo-Enhancement Procedure (LOEP) is an emerging treatment intended to address the pathology of osteoporosis of the hip: reduced bone volume, quality, and strength. This prospective single-center study assesses the first cases of AGN1 LOEP being performed in the same operative session in which the index hip fracture is repaired. The objective was to evaluate the procedure and safety of AGN1 LOEP when performed in that setting.

Methods: Post-menopausal women older than 65 who suffered a recent fragility fracture of the hip were treated with AGN1 LOEP in the contralateral proximal femur. The enhancement site is prepared and then injected with AGN1 (OSSURE[TM]), a proprietary, triphasic and osteoconductive implant material that is resorbed and replaced with bone. Patient demographics and procedural data were collected, including peri-operative safety events and the amount of incremental operative time required to perform AGN1 LOEP. The study was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster. All patients provided written consent.

Result: The first 5 patients enrolled in this 20-patient study were treated successfully with AGN1 LOEP. The treatment added a mean of 29 total minutes to the operative session (range: 23–34 minutes). The total incremental time comprised a mean of 18.8 minutes of skin-to-skin time for AGN1 LOEP (range: 13–30 minutes) and a mean of 10.2 minutes for patient repositioning (range: 4–15 minutes). There was no increase in peri-operative complications, length of stay, or time to weight-bearing. Patients followed the standard care map for geriatric hip fracture at the hospital with no modifications to accommodate for AGN1 LOEP. No adverse events related to the device or procedure were noted prior to discharge. Data from additional timepoints out to 24 months are pending.

Conclusions: These interim data from initial cases of contralateral AGN1 LOEP treatment of patients suffering fragility hip fractures support the safety profile of AGN1 LOEP. Patients successfully and safely underwent AGN1 LOEP during the same operative session in which the index hip fracture repair was performed. These results support further clinical study and warrant careful consideration for use by health-care professionals treating patients with fragility fractures of the hip.