106 Participants NeededMy employer runs this trial

Knee Immobilization for Postoperative Pain

(REST-Knee Trial)

SB
YB
Overseen ByYoan Bourgeault-Gagnon, MD FRCSC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Université de Sherbrooke
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

YB

Yoan Bourgeault-Gagnon, MD FRCSC

Principal Investigator

Université de Sherbrooke

FV

François Vaillancourt, MD FRCSC

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

Inclusion Criteria

I am having my first knee replacement for osteoarthritis at CHUS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants undergo primary unilateral TKA and are randomized to either wear a knee extension brace for 72 hours or follow standard care with early mobilization.

72 hours
In-hospital stay

Follow-up

Participants are monitored for pain, knee function, and other clinical outcomes at various intervals post-surgery.

12 months
2-5 days, 2 weeks, 6 weeks, 3 months, 12 months

Extension/Long-term follow-up

Participants continue to be monitored for long-term outcomes and safety.

Up to 18 months

What Are the Treatments Tested in This Trial?

Interventions

  • Knee Extension Brace

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Extension Brace GroupExperimental Treatment1 Intervention
Group II: Standard Care GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+