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

摘要 轻微移位的股骨颈骨折传统上采用内固定治疗，因为 很少需要切开复位，固定装置只需很少的手术解剖即可植入。AS 这种微移位骨折的内固定被认为有相对较低的并发症风险。 和死亡率。然而，最近的数据表明，接受内固定治疗的患者体验到了高 并发症发生率。最近的研究表明，关节成形术可以产生更好的结果，减少 重大再手术的风险，降低死亡率，改善机动性。虽然初步数据显示 支持使用关节置换术治疗微小移位的骨折是有希望的，临床实践将受益。 来自一项明确定义了这些骨折类型患者的最佳手术治疗的最终试验。 针对这一需求，我们提出了一项多中心随机对照试验，旨在确定 对于股骨颈骨折移位最小的患者，人工关节置换术优于内固定。如果 在拟议的试验中，关节置换术的结果优于内固定，这将为 治疗方法的广泛变化，改善了每年数以千计的患者的护理。为了 为了成功实施这一里程碑式的试验，我们提议18个月的规划期。我们将利用我们的 团队设计、实施和实施多中心随机对照试验的经验 开展可行的、以患者为中心的试验。在规划期内，我们将完成以下三项工作 具体目标：1)最终确定以患者为中心的试验方案；2)建立试验基础设施；3)准备 临床启蒙地点。

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.