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 微量移位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，并且只需很少的手术解剖即可植入固定装置。 因此，轻微移位骨折的内固定被认为并发症的风险相对较低 然而，最近的数据表明，接受内固定治疗的患者的死亡率较高。 最近的研究表明关节置换术可以带来更好的结果，减少并发症发生率。 重大再手术的风险、降低死亡率和改善流动性，而初步数据。 支持使用关节置换术治疗轻微移位骨折是有希望的，临床实践将受益 来自一项明确的试验，该试验明确定义了这些骨折类型患者的最佳手术治疗方法。 为了满足这一需求，我们提出了一项多中心随机对照试验，旨在确定是否 对于轻度移位的股骨颈骨折患者，关节置换术优于内固定术。 在拟议的试验中，关节置换术的结果优于内固定术，这将为 每年都会广泛改变治疗方法并改善数千名患者的护理。 为了成功实施这一具有里程碑意义的试验，我们提出了 18 个月的规划期。 团队设计、实施和进行多中心随机对照试验的经验 制定可行的、以患者为中心的试验 在规划期间，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，以及 3) 准备 启动的临床地点。