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

一项多中心随机临床试验的规划拨款，该试验比较髋关节置换术与内固定术治疗轻微移位的股骨颈骨折

• 批准号: 10654099
• 负责人: Nathan Noel O'Hara
• 金额: $ 23.2万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-07 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10654099
• 关键词: Address; Adopted; Adult; Caring; Clinical; Complication; Consensus; Contracts; Data; Data Management Resources; Devices; Dissection; Elderly; Ensure; Failure; Femoral Neck Fractures; Fracture; Funding; Grant; Health; Hip Fractures; Hospitals; Implant; In Situ; Individual; Infrastructure; Injury; Institutional Review Boards; Institutionalization; Modeling; Multicenter Trials; National Institute of Arthritis, and Musculoskeletal, and Skin Diseases; Operative Surgical Procedures; Orthopedics; Outcome; Patient-Focused Outcomes; Patients; Pattern; Phase; Principal Investigator; Process; Protocols documentation; Qualifying; Randomized; Randomized, Controlled Trials; Repeat Surgery; Replacement Arthroplasty; Research; Risk; Risk Reduction; Selection Criteria; Site; Statistical Data Interpretation; Surgeon; Target Populations; Testing; Training; Trauma; Work; clinical care; clinical practice; clinical research site; clinical trial protocol; design; experience; hip replacement arthroplasty; improved; improved mobility; mortality; mortality risk; novel; patient oriented; randomized, clinical trials; recruit; sample fixation; standard care; success; treatment choice; trial comparing; trial design

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.

摘要 轻微移位的股骨颈骨折传统上采用内固定治疗， 很少需要切开复位，并且固定装置可以在很少的外科解剖的情况下植入。作为 这样的最小移位骨折的内固定被认为具有相对低的并发症风险 and mortality.然而，最近的数据表明，接受内固定治疗的患者 并发症发生率。最近的研究表明，关节成形术可能会导致上级的结果，减少 重大再手术的风险，降低死亡率，并改善流动性。虽然初步数据 支持使用关节成形术治疗最小移位骨折是有希望的，临床实践将受益 从一个明确的试验，明确定义了最佳的手术治疗这些骨折类型的患者。 为了满足这一需求，我们提出了一项多中心随机对照试验，旨在确定 对于移位最小的股骨颈骨折患者，关节成形术上级内固定。如果 在拟议试验中，关节置换术的结局上级内固定，这将为以下方面提供依据： 广泛的治疗变化，并改善了成千上万的病人每年的护理。为了 为成功推行这项划时代试验计划，我们建议规划期为18个月。我们将利用我们 团队设计、实施和开展多中心随机对照试验的经验， 开展以患者为中心的可行性试验。在规划期内，我们会完成以下三项工作 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 临床试验机构启动。