72-hour knee extension brace after total knee replacement
Effect of 72-Hour Extension Splint Immobilization on Pain After Total Knee Arthroplasty: A Pilot Randomized Clinical Trial
This will try wearing a knee extension brace for the first 72 hours after a primary knee replacement to see if it reduces early pain and improves recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT07511842 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial at CHUS in Sherbrooke randomly assigns patients having primary unilateral total knee arthroplasty to either continuous immobilization in a Zimmer-type extension brace for 72 hours or to standard early mobilization, with a 1:1 allocation and blinded outcome assessors. Participants are followed for up to 12 months and clinical outcomes include pain measured by visual analog scale at 2 and 6 weeks, knee function, and range of motion. The trial’s primary objectives are feasibility measures—recruitment, adherence, follow-up completion, safety, and acceptability—while also exploring clinical signals of benefit. After the initial 72-hour period the intervention group receives standard physiotherapy consistent with usual care.
Who should consider this trial
Good fit: Adults undergoing primary unilateral total knee arthroplasty for osteoarthritis at CIUSSS de l'Estrie-CHUS who meet inclusion criteria and can attend local follow-up are the intended participants.
Not a fit: Patients with known thrombophilia or prior thromboembolic events, allergy to brace materials, revision or constrained prostheses, or those receiving continuous postoperative nerve block are excluded and thus would not receive this intervention.
Why it matters
Potential benefit: If successful, short-term postoperative immobilization could lower early pain after TKA, reduce opioid needs, and speed initial recovery.
How similar studies have performed: Short-term knee immobilization after TKA is a relatively novel approach with only limited and mixed prior data, so high-quality randomized evidence is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Person undergoing primary unilateral TKA for knee osteoarthritis at CHUS Exclusion Criteria: * Known thrombophilia or bleeding disorders * History of thromboembolic events * Contraindications to brace use (e.g., material allergy) * Revision or constrained knee prostheses * Use of continuous postoperative nerve block infusion
Where this trial is running
Sherbrooke, Quebec
- CIUSSS de l'Estrie-CHUS, 3001, 12e Ave Nord, Sherbrooke, Qc, Canada, J1H 5N4 — Sherbrooke, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Yoan Bourgeault-Gagnon, MD FRCSC — Université de Sherbrooke
- Study coordinator: Sonia Bedard, Masters
- Email: sonia.bedard2@usherbrooke.ca
- Phone: 1-819-346-1110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.