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

NCT07511842 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Total Knee Arthroplasty

Interventions

DEVICE

Knee Extension Brace (Zimmer-type)

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.

OTHER

Early Mobilization (Standard Care)

Participants will receive standard postoperative care, including early mobilization without restriction and supervised physiotherapy according to usual clinical practice.

Sponsors & Collaborators

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Yoan Bourgeault-Gagnon, MD FRCSC · Université de Sherbrooke

  • François Vaillancourt, MD FRCSC · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-03
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511842 on ClinicalTrials.gov