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Accepting PatientsObservationalNCT07879014

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

Rehabilitation Exercise

Phase:Observational
Status:Accepting Patients
Age:18 - 100
Gender:All
Locations:2 sites

What This Study Is About

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.

Who Can Participate

You 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 Cannot 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
  • +2 more...
Key Requirements
  • Age 18+ years
  • Able to provide informed consent
View Full Eligibility Criteria
Full Criteria (from ClinicalTrials.gov)

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

Important: This is a summary. The final determination of eligibility will be made by the trial coordinator after reviewing your complete medical history.

Study Locations

Mayo Clinic — Jacksonville, Florida
Hospital for Special Surgery — New York, New York

Experimental Treatment

This trial is testing a new treatment. Results are not guaranteed. Talk to your doctor before applying.

Apply to This Trial

Your information will be sent to the study coordinator for review.