Hemiarthroplasty versus total hip arthroplasty for displaced femoral neck fracture in patients older than 80 years: A randomized trial protocol

BACKGROUND: The forms of treatment which are available for these patients include internal fixation, hemiarthroplasty (HA), or total hip arthroplasty (THA). Both HA and THA are widely used methods of hip replacement after displaced femoral neck fracture (DFNF). Our purpose is to analyze the long-term outcomes of these 2 different forms of treatment, which are suitable for active patients with femoral neck intracapsular fractures ≥80 years of age without advanced osteoarthritis or rheumatoid arthritis. METHODS: This study is designed as a single-center randomized controlled trial. The participants will be randomly assigned to either the THA group or the HA group. Information will be collected from all participants after obtaining written informed consent in accordance with the Declaration of Helsinki and ethical board approval. Inclusion criteria include: displaced intracapsular femoral neck fracture, capability to obtain informed consent, no known metastatic disease, no contraindications to anesthesia, age ≥80 years, and ability to understand written Chinese. Patients will be evaluated at 3 months, 6 months, 1 year, and 3 years after surgery. At the time of the final follow-up, patients were assessed with use of the Harris hip score (HHS) and walking distance. Secondary outcomes of interest include postoperative complications, including 90-day medical complications (acute myocardial infarction, deep vein thrombosis, pulmonary embolism, intestinal obstruction, renal failure, and pneumonia) and surgical complications within 1 year (dislocation, infection, and revision replacement). RESULTS: This trial is expected to be the largest randomized trial assessing the efficacy of THA and HA and powered to detect a potential difference in the primary outcome. TRIAL REGISTRATION: This study protocol has been registered in Research Registry (researchregistry6203).