REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes
Effect of 72-Hour Extension Splint Immobilization on Pain After Total Knee Arthroplasty: A Pilot Randomized Clinical Trial
Université de Sherbrooke
106 participants
Mar 3, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Person undergoing primary unilateral TKA for knee osteoarthritis at CHUS
Exclusion Criteria5
- 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
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Interventions
Participants will wear a knee extension brace maintaining the operated knee in full extension for 72 hours following surgery. The brace is to be worn continuously (target ≥23 hours per day), after which standard physiotherapy care will be initiated.
Participants will receive standard postoperative care, including early mobilization without restriction and supervised physiotherapy according to usual clinical practice.
Locations(1)
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NCT07511842