Quiet Knee Protocol after knee replacement
Official title: Evaluating the Efficacy of a "Quiet Knee Protocol" in Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Study
Run by Mayo Clinic · NCT07879014 · Data updated 2026-11-12
A randomized study tests whether a Quiet Knee Protocol after unilateral knee replacement helps with pain, range of motion, and recovery better than standard rehab.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 170 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT07879014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) undergoing unilateral primary knee replacement for osteoarthritis who can follow the rehabilitation plan and provide informed consent.
✕Probably not a fit
Patients with prior knee surgeries within 12 months, neuromuscular disorders affecting mobility, or conditions preventing adherence to the rehabilitation protocol may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective randomized trial compares the Quiet Knee Protocol to standard postoperative rehabilitation in adults undergoing unilateral primary total knee arthroplasty for osteoarthritis. Participants complete questionnaires and are followed for 12 months to assess pain control, range of motion, functional recovery, opioid use, and satisfaction. The study also looks at whether the protocol reduces the need for formal physical therapy and rates of manipulation under anesthesia. Primary care teams at Mayo Clinic and collaborators will supervise the two rehabilitation strategies and collect outcome data. The trial emphasizes adherence to assigned rehabilitation and excludes certain prior knee procedures and conditions that could affect mobility.
Why it matters
Potential benefit: If successful, the Quiet Knee Protocol could improve pain relief and functional recovery after knee replacement and may reduce the need for additional physical therapy.
How similar studies have gone: Previous rehab protocols show potential benefits in recovery after knee replacement, but this specific Quiet Knee Protocol is a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years) undergoing unilateral primary TKA for osteoarthritis * Willingness to adhere to the assigned rehabilitation protocol * Ability to provide informed consent Exclusion Criteria: * Revision TKA or bilateral procedures * Preexisting neuromuscular disorders affecting mobility * Prior knee surgery within 12 months * No Joint Hardware * Agree to avoid plane trips post-surgery for 2 weeks * Patients with 100-degree flexion contracture * Pregnant subjects
Where it's running
-
Mayo Clinic
Jacksonville, Florida, United States Recruiting -
Hospital for Special Surgery
New York, New York, United States Not yet 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.