Less therapy, better knees? mayo clinic tests Hands-Off rehab after replacement
NCT ID NCT07879014
First seen Oct 16, 2026 · Last updated Oct 16, 2026
Summary
Researchers at Mayo Clinic are comparing two rehabilitation approaches after total knee replacement. One group follows a standard protocol with physical therapy starting days after surgery. The other group follows a 'Quiet Knee Protocol' that delays physical therapy for two weeks, using only active range of motion exercises. The trial measures knee motion at six weeks and tracks pain, opioid use, additional procedures, and patient satisfaction over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a rehabilitation protocol that delays physical therapy for two weeks after knee replacement surgery
- What this could lead to
- If the Quiet Knee Protocol works, patients might recover with less formal physical therapy, saving time and money while still regaining knee function.
- What could go wrong
- Delaying physical therapy could slow recovery or lead to stiffness, and the trial may show no difference from standard care. Results may not apply to people with prior knee surgery or other joint problems.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 170 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital for Special Surgery
NOT_YET_RECRUITINGNew York, New York, 10021, United States
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of visual and vestibular rehabilitation on postural stability, pain, functional status, and lower extremity biomechanics in individuals with knee osteoarthritis: a randomized controlled trial
- Low-Dose radiotherapy for painful knee osteoarthritis: a multicenter, interdisciplinary, prospective Single-Arm study
- Multiple health conditions may slow knee replacement recovery
- Can Bone-Protecting drugs shield knee cartilage from Walk-Induced breakdown?
- Knee braces put to the test in large Real-World registry
- Virtual pools may help knee replacement patients walk and balance better