An interventional study of Quiet Knee Protocol and Post Operative Standard of Care in Rehabilitation Exercise, sponsored by Mayo Clinic. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Prevention
The goal of this randomized clinical trial is to access the following:
Patients will be randomized into either a standard of care arm vs QKP rehabilitation protocol arm. Each group will answer questionnaires and be followed for 12 months.
Mayo Clinic is the lead sponsor of 3,263 studies on the registry; 670 are open to participants now.
Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Standard of Care arm will receive physical rehabilitation days after surgery which involves moving the limb through range of motion. This is the normal standard of care for post-operative knee surgery patients.
Other: Post Operative Standard of Care
Quiet Knee Protocol arm will receive no physical rehabilitation after surgery for two weeks. After two weeks, individuals will begin physical rehabiliatation with a physical therapist.
Other: Quiet Knee Protocol
Quiet Knee Protocol arm will receive no physical rehabilitation from a physical therapist after surgery for two weeks. Patients in this group will only perform active range of motion post-operatively before starting physical rehabilitation.
Standard of Care arm will receive physical rehabilitation days after surgery which involves moving the limb through range of motion. This is the normal standard of care for post-operative knee surgery patients.
Range of Motion (PROM)
The primary endpoint of this study postoperative range of motion (flexion and extension) at 6 weeks following TKA. This will be measured by trained individuals (Investigator, trained study staff, physical therapist) with the use of a goniometer.
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Incidence of Manipulation Under Anesthesia
Incidence of MUA will be recorded
Time frame: Post-Operative up to 1 year post op
Activity levels and functional recovery scores
KOOS Jr questionnaire will be completed to measure activity levels and functional recovery scores
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
PT utilization
PT utilization will be recorded on a weekly basis.
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Knee Circumference
Knee Circumference will be measured by Investigator, trained study staff, physical therapist.
Time frame: Preoperative, 2 weeks, and 6 weeks
Narcotic consumption
Narcotic consumption will be recorded
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Patient-reported pain scores
Patient-reported pain scores (Visual Analog Scale) will be completed.
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Patient-reported satisfaction with rehabilitation
Patient-reported satisfaction with rehabilitation questionnaire will be completed.
Time frame: 3 months post-operatively
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2029, 39 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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