Rehabilitation ExerciseQKPNCT07879014
Evaluating the Efficacy of a "Quiet Knee Protocol" in Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Study
A study testing Quiet Knee Protocol in people with Rehabilitation Exercise, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rehabilitation Exercise
- What is being tested?
- Quiet Knee Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) undergoing unilateral primary TKA for osteoarthritis
- Willingness to adhere to the assigned rehabilitation protocol
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Lauren Evans, DPT, 904-953-5416, Evans.Lauren2@mayo.edu
Niall Cochrane, MD
- Not yet recruiting
Hospital for Special Surgery
New York, New York, 10021
Allina Nocon, PHD MPH, 646-714-6015, Nocona@HSS.edu
About this study
The goal of this randomized clinical trial is to access the following:
- Compare the effectiveness of the QKP versus a standard rehabilitation protocol in improving postoperative pain control, ROM, and functional recovery following primary TKA.
- Assess whether the QKP reduces reliance on formal PT services.
- 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
- Being tested
- Quiet Knee Protocol, Post Operative Standard of Care
- Keywords
- Quiet Knee Protocol, Orthopedic Surgery, Knee Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quiet Knee ProtocolOther
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 CareOther
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 group | Role | What they receive |
|---|---|---|
| Standard of Care Group | Active comparator | 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. Receives: Other: Post Operative Standard of Care |
| Quiet Knee Protocol | Experimental | 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. Receives: Other: Quiet Knee Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Secondary outcomes (7)
Incidence of Manipulation Under Anesthesia
Incidence of MUA will be recorded
Measured: 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
Measured: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
PT utilization
PT utilization will be recorded on a weekly basis.
Measured: 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.
Measured: Preoperative, 2 weeks, and 6 weeks
Narcotic consumption
Narcotic consumption will be recorded
Measured: 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.
Measured: 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.
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rehabilitation ExerciseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Responsible party
- Principal investigator, Niall Cochrane, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879014
- Sponsor's protocol ID
- 25-010357
- Acronym
- QKP
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of a "Quiet Knee Protocol" in Primary Total Knee Arthroplasty (TKA): A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07879014
- Acronym / sponsor ID
- QKP / 25-010357
- Conditions
- Rehabilitation Exercise
- Keywords
- Quiet Knee Protocol, Orthopedic Surgery, Knee Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Hospital for Special Surgery, New York
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized clinical trial is to access the following:
- Compare the effectiveness of the QKP versus a standard rehabilitation protocol in improving postoperative pain control, ROM, and functional recovery following primary TKA.
- Assess whether the QKP reduces reliance on formal PT services.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Group | Active comparator | Other: Post Operative Standard of CareStandard 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. |
| Quiet Knee Protocol | Experimental | Other: Quiet Knee ProtocolQuiet 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) undergoing unilateral primary TKA for osteoarthritis
- Willingness to adhere to the assigned rehabilitation protocol
- Ability to provide informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quiet Knee ProtocolQuiet 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. | Other | Quiet Knee Protocol |
| Post Operative Standard of CareStandard 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 | Standard of Care Group |
Primary outcome
Range of Motion (PROM)
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
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.
7 secondary outcomes
Incidence of Manipulation Under Anesthesia
Time frame: Post-Operative up to 1 year post op
Activity levels and functional recovery scores
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
PT utilization
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Knee Circumference
Time frame: Preoperative, 2 weeks, and 6 weeks
Narcotic consumption
Time frame: 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Patient-reported pain scores
Time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively
Patient-reported satisfaction with rehabilitation
Time frame: 3 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quiet Knee Protocol in people with Rehabilitation Exercise, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (PROM) (time frame: Preoperative, 2 weeks, 6 weeks, 3 months, and 1 year post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.