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.

关节镜辅助胫骨高原固定（AATPF）与开放还原内固定 （ORIF）：多中心随机对照试验 项目摘要/摘要 胫骨高原骨折固定的当前标准治疗，开放还原内固定 （Orif），具有重大局限性，包括手术部位感染，疼痛，僵硬和A 长时间的非重量轴承限制期。 Orif的大软组织解剖为 与手术部位感染的风险增加以及关节可视化有限有关 这种手术方法的降低与未来总膝盖的风险增加有关 关节术继发于创伤后骨关节炎。1-6关节镜辅助胫骨高原 固定（AATPF）可直接可视化关节表面，而侵入性最小， 加速术后恢复并保留了联合寿命。7,8几项研究已有 报道了良好的结果，胫骨外侧高原的AATPF并发症率低 骨折。9,10但是，没有I级证据比较AATPF的结果和结果 传统的Orif方法。我们设计了一个随机对照试验（RCT） 比较胫骨外侧患者的患者报告，临床和放射线结果 用AATPF与Orif处理的高原骨折为提供高级证据数据 临床医生。拟议的R34预研究前计划期对于成功 启动并完成RCT。