What this study is
The goal of this randomized clinical trial is to access the following:
1. Compare the effectiveness of the QKP versus a standard rehabilitation protocol in improving postoperative pain control, ROM, and functional recovery following primary TKA. 2. Assess whether the QKP reduces reliance on formal PT services. 3. Evaluate the impact of QKP on secondary outcomes, including opioid consumption, manipulation under anesthesia (MUA) rates, and patient satisfaction scores.
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.
What's being tested
- Quiet Knee Protocol
Intervention · OTHER
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.
- Post Operative Standard of Care
Intervention · OTHER
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.
Study details
- Sponsor
- Mayo Clinic
- Conditions
- Rehabilitation Exercise
- Enrolling
- 170 people
- Starts
- 2026-09
- Est. completion
- 2030-12
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 100 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults (≥18 years) undergoing unilateral primary TKA for osteoarthritis
- Willingness to adhere to the assigned rehabilitation protocol
- Ability to provide informed consent
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openMayo Clinic
Jacksonville, Florida, United States
- Lauren Evans, DPT · Contact904-953-5416Evans.Lauren2@mayo.edu
- Niall Cochrane, MD · Principal investigator
- Bryan Springer, MD · Sub-investigator
RecruitingHospital for Special Surgery
New York, New York, United States
- Allina Nocon, PHD MPH · Contact646-714-6015Nocona@HSS.edu
Not yet recruiting
Study team
Sponsor
Mayo Clinic
Study ID 25-010357
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.