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.

抽象的 传统上，股骨颈部骨折最小的股骨颈部骨折是通过内部固定治疗的 很少需要开放式减少，并且固定装置几乎没有手术解剖就可以植入。作为 这样的内部固定最小骨折的内在骨折被认为具有并发症的风险相对较低 和死亡率。但是，最近的数据表明，接受内固定治疗的患者经验很高 并发症率。最近的研究表明，关节置换术可能导致卓越的结果，从而减少。 重新工作的风险，降低死亡率和改善流动性。而初步数据 支持将关节置换术用于最小移位的骨折是有希望的，临床实践将受益 从一项定义的试验中明确定义了这些骨折类型患者的最佳手术治疗。 在满足这种需求时，我们提出了一项多中心随机对照试验，旨在确定是否是否 关节置换术优于股骨颈部骨折最小移位的患者的内固定。如果 在拟议的试验中，关节置换术的结局优于内固定，它将为 每年的治疗宽度变化并改善了数千名患者的护理。为了 成功实施了这项具有里程碑意义的试验，我们提出了一个18个月的计划期。我们将利用我们的 团队的经验设计，实施和进行多中心随机对照试验 开发可行且以患者为中心的试验。在计划期间，我们将完成以下三个 具体目的：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 启动临床部位。