Efficacy and safety of proximal femoral anatomical locking compression plate and proximal femoral nail antirotation for long-segment comminuted subtrochanteric fractures of the femur: a non-randomized controlled trial

Background and objective: The proximal femoral anatomical locking compression plate and proximal femoral nail antirotation device are commonly used in the treatment of long-segment comminuted subtrochanteric fractures of the femur. However, few studies have evaluated the difference in efficacy and safety between these two implants. The present study is being performed to compare the efficacy and safety of the proximal femoral anatomical locking compression plate versus proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur. The results will be used to identify the optimal implant treatment plan. Participants and methods: This prospective, single-center, non-randomized controlled clinical trial will include 180 patients with long-segment comminuted subtrochanteric fractures of the femur from Sanya Traditional Chinese Medicine Hospital, China. The patients will be equally divided into a locking compression plate group and a proximal femoral nail antirotation group. All patients will be followed up at 2 and 10 months postoperatively. Patient recruitment and data collection will begin on June 30, 2019 and end on June 30, 2020. Analysis of the results will be performed from 1 to 30 July 2020. This study will be scheduled to end on August 1, 2022. This study was approved by the Medical Ethics Committee of Sanya Traditional Chinese Medicine Hospital in China in March 2013 (approval No. (2013) (02)). Study protocol version is 1.0. This study will be performed in strict accordance with the Declaration of Helsinki formulated by the World Medical Association. Written informed consent regarding the study protocol and surgery procedure will be obtained from the participants. Results: The primary outcome measure is the rate of excellent and good Harris hip scores at 10 months postoperatively; this rate will be used to evaluate the recovery of hip function after repair. The secondary outcome measures are the rate of excellent and good Harris hip scores preoperatively and 2 months postoperatively, intraoperative blood loss, operation time, incision length, hospital stay, fracture healing time, hip morphology on radiographs preoperatively and 2 months postoperatively, and incidence of adverse events 2 and 10 months postoperatively. Our pilot study involved 80 patients with long-segment comminuted subtrochanteric fractures of the femur from February 2013 to February 2016 (locking compression plate group, n = 40; proximal femoral nail antirotation group, n = 40). The 10-month follow-up results showed that the intraoperative blood loss, operation time, incision length, hospital stay, and fracture healing time were lower in the proximal femoral nail antirotation group than in the locking compression plate group (P 0.05). These pilot study results verified higher efficacy and safety of proximal femoral nail antirotation than locking compression plate fixation in the treatment of long-segment comminuted subtrochanteric fractures of the femur. Conclusion: The results of the present study will provide evidence indicating whether proximal femoral nail antirotation in the treatment of long-segment comminuted subtrochanteric fractures of the femur can facilitate better recovery of hip function and higher safety than anatomical locking compression plate fixation. Trial registration: This study was registered with the Chinese Clinical Trial Registry on February 3, 2019 (registration number: ChiCTR1900021251).