Clinical outcomes of proximal femoral fractures treated with a novel carbon fiber-reinforced polyetheretherketone intramedullary nail.

Abstract

We developed a new carbon fiber-reinforced polyetheretherketone (CFR/PEEK) intramedullary nail for proximal femoral fractures. This study aimed to examine the efficacy and safety of the CFR/PEEK intramedullary nail for use in the treatment of patients with proximal femoral fractures. This multicentre single-arm clinical trial enrolled 20 patients (3 men, 17 women; mean age 85.0 years, range 72-95 years) with proximal femoral fractures treated with the CFR/PEEK intramedullary nail. The follow-up period was >4 months. Primary outcomes were union of the bone fracture, time to bone union, bone nonunion, complications, implant failure, and the reoperation rate. Secondary outcomes were fracture reduction success, and clinical scores using the Harris hip score, Barthel index, Vitality index, Mini-Mental State Examination, and Numerical Rating Scale. Among the 20 patients with proximal femoral fractures treated with CFR/PEEK intramedullary nails, 19 (95%) were confirmed to display bone union within 3.7 months (range 2.8-10.0 months). One patient was diagnosed as having bone nonunion, although the patient did not complain any pain, and there was no radiological evidence of failure after a follow-up period of >18 months. There were no complications (e.g., cut out, infection, hardware failure), and reoperation was not required. Fracture reduction was good and acceptable in all cases, and the mean tip-apex distance was 13.5 mm (range 9.0-19.1 mm). The results indicated that preoperative activity was maintained (preoperative and postoperative Harris hip scores were 73.2 and 71.0 points, respectively; p = 0.61). There were no adverse reactions or failures related to the CFR/PEEK implant, and it provided satisfactory clinical results and a high union rate. Thus, use of the novel CFR/PEEK intramedullary nail is feasible.