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Evaluating the Efficacy of a "Quiet Knee Protocol" in Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Study

RecruitingNAAges 18 Years - 100 YearsAllMayo Clinic
NCT07879014 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Quiet Knee Protocol
  • Post Operative Standard of Care
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Where

2 sites
Mayo Clinic
Jacksonville, United States
Hospital for Special Surgery
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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