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

Sponsor
Université de Sherbrooke
Study ID
NCT07511842
Status
Recruiting
Apply to this trial

Conditions

  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Knee Extension Brace (Zimmer-type) — DEVICE
    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.
  • Early Mobilization (Standard Care) — OTHER
    Participants will receive standard postoperative care, including early mobilization without restriction and supervised physiotherapy according to usual clinical practice.

Study Details

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.

Key Dates

First listed
Apr 6, 2026
Start date
Mar 3, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Active Comparator: Standard Care Group
    Participants will receive standard postoperative care consisting of early mobilization without movement restriction and supervised physiotherapy according to usual clinical practice.

Primary Outcome Measure

Study feasibility [ Time Frame: Up to 18 months (study completion) ]

Central Contacts

Related Studies