REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this trial

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 criteria

Qualifiers

Person undergoing primary unilateral TKA for knee osteoarthritis at CHUS

Disqualifiers

Known thrombophilia or bleeding disorders

History of thromboembolic events

Contraindications to brace use (e.g., material allergy)

Revision or constrained knee prostheses

Trial design

Treatments tested in this trial

  • Knee Extension Brace (Zimmer-type)
  • Early Mobilization (Standard Care)

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators