Recruiting

QKP vs. Standard Care

Sponsor:

Mayo Clinic

Code:

NCT07879014

Conditions

Rehabilitation Exercise

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Quiet Knee Protocol

Post Operative Standard of Care

Study Details

Brief summary:

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.

Conditions

Rehabilitation Exercise

Study ID

NCT07879014

Start date

Sep, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Group

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.

experimental: Quiet Knee Protocol

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.

Interventions

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.

Post Operative Standard of Care

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.

Primary outcome measure

  • Range of Motion (PROM) [ Time Frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Lauren Evans, DPT

904-953-5416Evans.Lauren2@mayo.edu

Principal Investigator:

Niall Cochrane, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Keywords

  • Quiet Knee Protocol
  • Orthopedic Surgery
  • Knee Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.