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Effect of 72-Hour Extension Splint Immobilization on Pain After Total Knee Arthroplasty: A Pilot Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Person undergoing primary unilateral TKA for knee osteoarthritis at CHUS

Locations
Other Locations
Canada
CIUSSS de l'Estrie-CHUS, 3001, 12e Ave Nord, Sherbrooke, Qc, Canada, J1H 5N4
RECRUITING
Sherbrooke
Contact Information
Primary
Sonia Bedard, Masters
sonia.bedard2@usherbrooke.ca
1-819-346-1110
Backup
Yoan Bourgeault-Gagnon, MD FRCSC
yoan.bourgeault-gagnon@usherbrooke.ca
Time Frame
Start Date: 2026-03-03
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 106
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Université de Sherbrooke

This content was sourced from clinicaltrials.gov