Clinical outcomes of proximal femoral fractures treated with a novel carbon fiber-reinforced polyetheretherketone intramedullary nail. Issue 3 (March 2020)

• Record Type: Journal Article
• Authors: Takashima, Kazuma; Nakahara, Ichiro; Uemura, Keisuke; Hamada, Hidetoshi; Ando, Wataru; Takao, Masaki; Sugano, Nobuhiko
• Is Part Of: Injury. Volume 51:Issue 3(2020)
• Page Start: 678
• Page End: 682
• Publication Date: 2020-03
• Subjects: Carbon fiber-reinforced polyetheretherketone -- Intramedullary nail -- Proximal femoral fractures -- Clinical trial; Wounds and injuries -- Surgery -- Periodicals; Accidents -- Periodicals; Wounds and Injuries -- surgery -- Periodicals; Lésions et blessures -- Chirurgie -- Périodiques; Electronic journals; Electronic journals; 617.1
• DOI: 10.1016/j.injury.2020.01.007
• Languages: English
• ISSNs: 0020-1383

Abstract

Highlights: Carbon fiber-reinforced polyetheretherketone (CFR/PEEK) is more suitable as a material for fracture fixation devices over metals. Optimal stiffness may improve fracture healing without surrounding bone atrophy, and excellent fatigue resistance prevents implant breakage. X-ray permeability can be useful for confirming fracture reduction, new bone formation, and bone union. We developed newly designed implants for proximal femoral fractures using CFR/PEEK. The newly developed CFR/PEEK intramedullary nail provided satisfactory clinical results. Abstract: Introduction: 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. Methods: 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. Results: 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). Conclusion: 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.