Health TrialsbyHealthPanel

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

ConditionTotal Knee Arthroplasty
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Extension Brace GroupExperimental treatment 1 intervention
Group B: Standard Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Study feasibility

Feasibility will be assessed by recruitment rate, follow-up completion (target ≥80%), intervention adherence (target ≥80%), and safety based on postoperative complications.

Time frame
Up to 18 months (study completion)

Secondary outcomes

1

Postoperative Pain (VAS)

Pain measured using a 100-mm Visual Analog Scale.

Time frame
2 weeks, 6 weeks, 3 months, 12 months
2

Knee Range of Motion (ROM)

Measured with a goniometer.

Time frame
2 weeks, 6 weeks, 3 months, 12 months
3

Opioid Consumption

Self-reported number of tablets consumed.

Time frame
Up to 6 weeks
4

Postoperative Complications

Includes wound complications, infection, and thromboembolic events.

Time frame
Up to 6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

Source ClinicalTrials.gov
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