Contralateral Prophylactic Reinforcement in Case of First Low-Energy Hip Fracture: First-in-Man Clinical Data of a New Percutaneous Internal Fixation Device

A prevention dedicated osteosynthesis device (Y-STRUT®, Hyprevention) was developed to reinforce the proximal femur on patients with high risk of fragility hip fracture. A multicentre pilot study was initiated to evaluate the feasibility, safety and tolerance of this device and the related operative procedure. This clinical study is an on-going prospective series of 15 patients. Between February 2013 and December 2016, 10 patients were implanted. Patients were recruited when arriving to emergencies following a low-energy trauma leading to a pertrochanteric hip fracture. The device was implanted in combination with bone cement into the contralateral hip during the same anaesthesia as the fractured hip fixation. Clinical evaluation includes pain evaluation, functional status, and osteointegration of the device. Mean age of patients was 82 ± 7 years. Mean duration of implantation was 56 ± 19 min for Y-STRUT® implantation and 37 ± 24 for fracture fixation in the opposite side. Mean cement quantity injected was 8 ± 1.6 ml. At 3 months, WOMAC scores for pain and functionality were 5 and 24, respectively and 4 and 18 at 12 months. Mean follow-up is 16 ± 12 months. No patient died during the follow-up. No osteolysis nor post-operative fracture were observed. Preliminary results of this prospective study showed the feasibility, safety and tolerance of the implantation of this new device. Further patients are required to confirm this experience and confirm efficacy of the device to reduce the risk of contralateral hip fracture during the first year after the first fracture when elderly patients are at the highest risk of fracture and mortality and the anti-osteoporosis medication prescribed at fracture is not yet efficient.