Effect of 72-Hour Extension Splint Immobilization on Pain After Total Knee Arthroplasty: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Study feasibility
研究概览
简要总结
Postoperative pain following total knee arthroplasty (TKA) is often difficult to manage, particularly with the increasing use of outpatient surgery where patients recover at home. This study aims to evaluate whether wearing a knee extension brace for the first 72 hours after surgery can reduce pain and improve recovery.
This pilot randomized controlled trial will compare two groups of patients undergoing primary unilateral TKA: one group will wear an extension brace continuously for 72 hours after surgery, while the control group will follow standard care with early mobilization. Participants will be followed for up to 12 months.
The primary objective of this pilot study is to assess the feasibility of conducting a larger trial, including recruitment rates, adherence to the intervention, follow-up completion, safety, and acceptability. Clinical outcomes will also be explored, including pain at 2 and 6 weeks after surgery (measured using a visual analog scale), knee function, range of motion, opioid consumption, complications, healthcare use, and quality of life.
The study hypothesizes that short-term immobilization of the knee in full extension will reduce postoperative pain and may improve early recovery outcomes. Findings from this pilot study will inform the design of a larger definitive trial and may contribute to improving postoperative care and pain management after knee replacement surgery.
详细描述
Postoperative pain following total knee arthroplasty (TKA) remains a significant clinical challenge, particularly in the context of increasing use of outpatient surgical pathways. Optimizing early postoperative pain management is essential to improve recovery, reduce unplanned healthcare utilization, and support enhanced recovery after surgery (ERAS) principles.
This study aims to evaluate the effect of short-term postoperative immobilization using a knee extension brace (Zimmer-type) worn continuously for 72 hours following primary unilateral TKA on postoperative pain at 2 and 6 weeks, measured using the Visual Analog Scale (VAS). The study hypothesizes that maintaining the knee in full extension during the immediate postoperative period will reduce pain and improve early recovery outcomes.
Study Design
This study is a pilot randomized controlled trial with a 1:1 allocation ratio and a single-blind design, in which outcome assessors are blinded to group allocation. The study is conducted at a single center (CHUS, Estrie, Canada).
Participants undergoing primary unilateral TKA will be randomized into one of two groups:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Person undergoing primary unilateral TKA for knee osteoarthritis at CHUS
排除标准
- •Known thrombophilia or bleeding disorders
- •History of thromboembolic events
- •Contraindications to brace use (e.g., material allergy)
- •Revision or constrained knee prostheses
- •Use of continuous postoperative nerve block infusion
研究组 & 干预措施
Extension Brace Group
Participants will undergo postoperative immobilization of the operated knee in full extension using a Zimmer-type knee brace for 72 hours following primary total knee arthroplasty, followed by standard physiotherapy care.
干预措施: Knee Extension Brace (Zimmer-type) (Device)
Standard Care Group
Participants will receive standard postoperative care consisting of early mobilization without movement restriction and supervised physiotherapy according to usual clinical practice.
干预措施: Early Mobilization (Standard Care) (Other)
结局指标
主要结局
Study feasibility
时间窗: Up to 18 months (study completion)
Feasibility will be assessed by recruitment rate, follow-up completion (target ≥80%), intervention adherence (target ≥80%), and safety based on postoperative complications.
次要结局
- Postoperative Pain (VAS)(2 weeks, 6 weeks, 3 months, 12 months)
- Knee Range of Motion (ROM)(2 weeks, 6 weeks, 3 months, 12 months)
- Opioid Consumption(Up to 6 weeks)
- Postoperative Complications(Up to 6 weeks)
- Healthcare Utilization(Up to 6 weeks)
- Quality of Life (EQ-5D-5L)(Baseline, 2 weeks, 6 weeks, 3 months, 12 months)
- Knee Function (KSS/FKSS)(Baseline, 6 weeks, 3 months, 12 months)
- Inflammation (CRP)(Blood test marker.)
- Hemoglobin(2-5 days and 6 weeks)
- Global Improvement (PGI-C)(2 and 6 weeks)
- Brace Compliance(First 72 hours)
- Perceived Safety(2 weeks)