Supercapsular percutaneously-assisted total hip approach for the elderly with femoral neck fractures: study protocol for a prospective, open-label, randomized, controlled clinical trial

Abstract

Background: Artificial hip replacement by the posterolateral approach is generally introduced as a treatment for femoral neck fracture in the elderly, but it is limited by the need for a large incision, cutting off the extortor, and postoperative hip dislocation. The supercapsular percutaneously-assisted total hip (SuperPATH) approach was developed based on the original lateral approach. The SuperPATH approach for hip replacement is characterized by the reduced chance of damaging blood vessels and nerves, reducing intraoperative blood loss, retaining all the joint capsules and supinator, and significantly reducing the incidence of postoperative hip dislocation. Given these advantages, we hypothesized that the SuperPATH approach for hip replacement can achieve better efficacy in the elderly with femoral neck fractures and promote the recovery of postoperative hip function compared with the posterolateral approach. Methods/Design: This is a prospective, single-center, open-label, randomized controlled clinical trial that will be completed at the Pudong Hospital of Fudan University, Shanghai, China. Forty patients with femoral neck fractures were randomly divided into two groups to undergo femoral head replacement by the SuperPATH approach in the experimental group, and by the conventional posterior approach in the control group. The follow-up period is 1 week and 6 months. The primary outcome measure is Harris hip scores at baseline, and at 1 week and 6 months postoperatively to assess functional recovery of the hip. Secondary outcome measures to evaluate the advantages of the SuperPATH approach include the length of surgical incision, intraoperative blood loss, operative time, 24-hour postoperative drainage, and hospital stay. Other outcome measures include the incidence of adverse events at 1 week and 6 months after surgery. Discussion: The aim of this trial is to test our hypothesis that the SuperPATH approach is safer and more reliable for hip functional recovery compared with the posterolateral approach for the artificial hip replacement in femoral neck fractures of the elderly. Trial registration: ClinicalTrials.gov identifier: NCT03134664. Ethics: The study protocol was approved by the Ethics Committee of the Pudong Hospital of Fudan University, China, and performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from all participants prior to the trial commencement.