Wearing a straight knee brace for 10 days after revision knee replacement to improve motion.
Official title: Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?
Run by Hospital for Special Surgery, New York · NCT07552415 · Data updated 2026-11-12
This trial tests whether wearing a straight knee brace for 10 days after aseptic revision knee replacement helps people regain better knee motion at 3 months compared with standard physical therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | January 2027 |
| Study ends | April 2028 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07552415 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults having aseptic revision total knee arthroplasty of one or both components who are not being revised for stiffness, do not have occult infection or hinged reconstructions, have BMI under 40, are not on preoperative anticoagulation, have no history of VTE/PE, and do not have very high recent opioid use are ideal candidates.
✕Probably not a fit
Patients revised for stiffness, those with recognized or occult infection, hinged component reconstructions, BMI ≥40, active anticoagulation, a history of VTE/PE, or very high preoperative opioid use are unlikely to be eligible or to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants undergoing aseptic revision total knee arthroplasty are randomly assigned to either wear a knee immobilizer that holds the knee straight for 10 days with no range-of-motion exercises or to follow the standard postoperative physical therapy program including early ROM exercises. The primary outcome is knee range of motion measured at 3 months after surgery, with secondary considerations for pain and opioid use. Key eligibility excludes revisions performed for stiffness, occult infection, hinged component reconstructions, very high BMI, preoperative anticoagulation, prior VTE/PE, and very high preoperative opioid use. The study is conducted at a single center (Hospital for Special Surgery) and compares a simple non-pharmacologic intervention to usual care.
Why it matters
Potential benefit: If successful, short-term knee immobilization could improve 3-month range of motion, reduce pain and opioid requirements, and offer a low-cost adjunct to post-revision care.
How similar studies have gone: Semirigid extension bracing has shown promising results in primary total knee arthroplasty for pain control, improved ROM, and lower opioid use, but its role after revision TKA has not been tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture. * Patients undergoing revision TKA of one or both components. Exclusion Criteria: * Patients who are undergoing revision TKA for stiffness. * Patients with occult infection not recognized prior to revision. * Patients with hinged TKA component reconstructions. * Patients undergoing revision for liner exchange. * History of VTE/PE. * Patients on pre-operative anticoagulation. * BMI ≥ 40. * Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)/day within 90 days of revision TKA.
Where it's running
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Hospital for Special Surgery
New York, New York, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.