A Planning Grant for a Multicenter Randomized Clinical Trial Comparing Hip Arthroplasty to Internal Fixation for Minimally Displaced Femoral Neck Fractures

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ABSTRACT Minimally displaced femoral neck fractures have traditionally been treated with internal fixation because an open reduction is rarely required and the fixation devices can be implanted with little surgical dissection. As such, internal fixation of minimally displaced fractures is perceived to have a relatively low risk of complications and mortality. However, recent data suggests that patients treated with internal fixation experience high complication rates. Recent research has suggested arthroplasty could result in superior outcomes, reducing the risk of major reoperations, decreasing mortality, and improving mobility. While the preliminary data supporting the use of arthroplasty for minimally displaced fractures is promising, clinical practice would benefit from a definitive trial that clearly defines the optimal surgical treatment for patients with these fracture types. Addressing this need, we propose a multi-center randomized controlled trial designed to determine if arthroplasty is superior to internal fixation in patients with a minimally displaced femoral neck fracture. If arthroplasty outcomes are superior to internal fixation in the proposed trial, it will provide a rationale for widespread changes in treatment and improve the care of thousands of patients each year. In order to successfully implement this landmark trial, we propose an 18-month planning period. We will leverage our team’s experience designing, implementing, and conducting multi-center randomized controlled trials to develop a feasible and patient-centered trial. During the planning period, we will complete the following three specific aims: 1) Finalize the patient-centered trial protocol; 2) Establish trial infrastructure, and 3) Prepare the clinical sites for initiation.