Clinical trial Recruiting at 1 site Interventional Ages 18 to 100

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 typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment170 (estimated)
SponsorMayo Clinic
Academic / other
Locations2 sites (Jacksonville, Florida and 1 other locations)
StatusRecruiting
StartedSeptember 2026
Main results expectedDecember 2029
Study endsDecember 2030
Registry record updatedOctober 16, 2026
Trial IDNCT07879014 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.