Pilot study: To assess feasibility and tolerability of a minimal invasive implantable PEEK device for prevention of contralateral osteoporotic hip fracture.

Abstract

A non-comparative multi-centre and international pilot study have been carried on Y-STRUT® (Hyprevention, France), an implantable medical device meant to reinforce the hip to reduce the risk of a contralateral hip fracture. Objectives of the study were to determine the feasibility and tolerance of the procedure. Methods Patients older than 60 years were recruited when presenting at the emergency departments with a low-energy pertrochanteric fracture on one side and with a fracture risk assessed for the contralateral side with BMD, T-Score or other bone quality evaluation tool, FRAX index, or fall risk assessment. Pain and functional ability were assessed at the different follow-up visits using VAS, WOMAC and OHS-12 scores. Results Twelve patients were included and reached a one-year follow-up. Mean age was 82 years old (65 - 91). The average hospital stay was 13 days (3 - 29). The prophylactic surgery did not delay the hospital discharge for any patient. The procedure did not lead to unresolvable serious adverse events. At 3 weeks, all patients were able to walk 6 meters, half of them in less of 30 seconds. Minimal pain was reported all along the follow-up visits, except at 3 years when one patient presented high pain in both hips. WOMAC and OHS-12 scores showed a moderate to mild hip impairment. Conclusion The good short and medium-term outcomes of this pilot study demonstrate the feasibility and the tolerability of the device. Further studies should focus on the efficacy of this immediate and lasting bone reinforcement technique.