Arthroscopic-assisted tibial plateau fixation (AATPF) vs. Open reduction internal fixation (ORIF): A multicenter randomized controlled trial

关节镜辅助胫骨平台固定术 (AATPF) 与切开复位内固定术 (ORIF)：一项多中心随机对照试验

• 批准号: 10723527
• 负责人: Mai P Nguyen
• 金额: $ 17.61万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-07 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10723527
• 关键词: Acceleration; Articular Range of Motion; Centers for Disease Control and Prevention (U.S.); Classification; Clinical; Collaborations; Committee Members; Complication; Data; Dissection; Documentation; Electronics; Eligibility Determination; Enrollment; Ensure; Fellowship; Fracture; Fracture Fixation; Funding; Future; Goals; Grant; Infection; Information Systems; Institutional Review Boards; Interdisciplinary Study; International; Joints; Knee; Knee joint; Lateral; Leadership; Level of Evidence; Limb structure; Longevity; Manuals; Measurement; Measures; Methods; Minnesota; Modeling; Monitor; Operative Surgical Procedures; Orthopedic Surgery; Orthopedics; Outcome; Pain; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Phase; Postoperative Period; Preparation; Protocols documentation; Randomized; Randomized, Controlled Trials; Recording of previous events; Recovery; Repeat Surgery; Reporting; Research; Research Infrastructure; Research Personnel; Risk; Safety; Sample Size; Secondary to; Site; Societies; Specialist; Sports; Surface; Surgeon; Surgical Wound Infection; Surgical complication; Testing; Time; Training; Trauma; Traumatic Arthropathy; Universities; Visual; Visualization; Weight-Bearing state; With laterality; adjudication; analog; clinical research site; cost efficient; data management; design; evidence base; follow-up; health related quality of life; hospital readmission; interest; knee pain; knee replacement arthroplasty; minimally invasive; operation; postoperative recovery; prescription opioid; preservation; primary outcome; radiological imaging; recruit; sample fixation; soft tissue; standard care; surgical risk; timeline; trial comparing; wound

Arthroscopic-assisted tibial plateau fixation (AATPF) vs. Open reduction internal fixation (ORIF): A multicenter randomized controlled trial Project Summary/Abstract The current standard treatment for tibial plateau fracture fixation, open reduction internal fixation (ORIF), has significant limitations including surgical site infections, pain, stiffness, and a prolonged period of non-weight bearing restrictions. The large soft tissue dissection for ORIF is associated with an increased risk of surgical site infections, and limited visualization of joint reduction in this surgical approach is associated with an increased risk of future total knee arthroplasty secondary to post-traumatic osteoarthritis.1-6 Arthroscopic-assisted tibial plateau fixation (AATPF) provides direct visualization of the articular surface with minimal invasiveness, accelerated post-operative recovery, and preserves joint longevity.7,8 Several studies have reported good outcomes with low complication rates of AATPF for lateral tibial plateau fractures.9,10 However, there is no Level I evidence comparing outcomes of AATPF and outcomes of the traditional ORIF approach. We have designed a randomized controlled trial (RCT) comparing patient-reported, clinical, and radiographic outcomes of patients with lateral tibial plateau fractures treated with AATPF vs. ORIF to provide high level evidence-based data for clinicians. The proposed R34 pre-study planning period is essential to successfully initiate and complete the RCT.

关节镜辅助胫骨平台固定术 (AATPF) 与切开复位内固定术 (ORIF)：一项多中心随机对照试验 项目概要/摘要 目前胫骨平台骨折内固定的标准治疗方法是切开复位内固定 （ORIF）具有显着的局限性，包括手术部位感染、疼痛、僵硬和 长时间的非负重限制。 ORIF 的大软组织解剖是 与手术部位感染风险增加以及关节可视化有限相关 减少这种手术方法会增加未来全膝关节置换术的风险 继发于创伤后骨关节炎的关节置换术1-6 关节镜辅助胫骨平台 固定（AATPF）以最小的侵入性提供关节表面的直接可视化， 加速术后恢复，并保持关节寿命。7,8 多项研究表明 据报道，AATPF 治疗胫骨外侧平台的结果良好，并发症发生率低 9,10 然而，没有 I 级证据比较 AATPF 的结果和结果 传统的 ORIF 方法。我们设计了一项随机对照试验（RCT） 比较胫骨外侧畸形患者的患者报告、临床和影像结果 使用 AATPF 与 ORIF 治疗的平台骨折，为以下患者提供高水平的循证数据 临床医生。拟议的 R34 研究前规划期对于成功至关重要 启动并完成 RCT。