Knee OsteoarthritisNCT06298721
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
A study testing Personalized outcome prediction tool + targeted interventions in people with Knee Osteoarthritis and Knee Arthropathy, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthropathy, Surgery
- What is being tested?
- Personalized outcome prediction tool + targeted interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2024to 1 Mar 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subject (Age >18 and < 80 years of age)
- The subject is proficient in the English language
- The patient is voluntarily prepared to sign the 'Informed Consent Form'
- The patient is scheduled for a unilateral primary TKA
- TKA PROMs Phenotypes with higher risk of dissatisfaction
- Patient is willing and able to complete the protocol required follow-up
Who cannot join
- Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart
- Patients undergoing revision TKA
- Inflammatory arthritis
- History of infection in the joint undergoing TKA
- Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Shujaa T Khan, MD, 4199658274, khans34@ccf.org
About this study
Official title: Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).
Read the detailed description
The potential candidates for the study are patients scheduled for primary TKA. Scheduled patients will be sent an invitation letter detailing the study's objectives and design. Should they choose to take part, individuals will be requested to utilize MyChart for the completion of PROMs. The information gathered from these PROMs will play a pivotal role in assessing their suitability for inclusion in the study. Subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). This enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. Subsequently, enrolled patients will be randomized in a 1:1 ratio to:
- Standard of Care ii) Standard of Care + TKA Personalized Outcome Prediction Tool (Mental Health Screening/Intervention \& Physical Therapy Pre-surgery Assessments/Intervention)
TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will be provided and discussed with the patients by the surgeon.
The primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the PASS anchor question at 1-year postoperative. The treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. We will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.
- Conditions
- Knee Osteoarthritis, Knee Arthropathy, Surgery
- Being tested
- Personalized outcome prediction tool + targeted interventions, Standard of Care TKA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized outcome prediction tool + targeted interventionsBehavioural
- TKA Personalized Outcome Prediction Tool to aid in setting expectations
- Mental Health Screening/Intervention
- Physical Therapy Pre-surgery Assessments \& Rehabilitation
Standard of Care TKABehavioural
- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care TKA | Active comparator | Patients scheduled to undergo TKA at Cleveland Clinic will follow the standardized TKA Care Pathway as part of Standard of care. Patients enter the TKA care path after consenting to undergo TKA for symptomatic knee pain that has not relieved with nonoperative measures. They stay in the care path until 90-days after the operation is complete. The TKA care path guides the care delivered through the preoperative, intraoperative and postoperative phases. Receives: Behavioral: Standard of Care TKA |
| Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions | Experimental | Patients who are identified to have a TKA PROMs phenotype which includes lower than median scores for VR-12 MCS will be further screened for:
Distress ➔ using the NCCN Distress Thermometer (DT) Depression ➔ using the Patient Health Questionnaire-9 Those patients with a score ≥ 8 on the DT, or a score ≥ 10 on the PHQ-9, or any response other than 0 to question 9 on the PHQ-9 will have a consult with Psychiatry and Behavioral Science to determine a mental health diagnosis.
Patients who are identified to have a TKA PROMS phenotype which includes lower than median scores for KOOS-PS (score of =<51.5) will be scheduled for a 4 to 8 week intervention of pre-rehabilitation. All patients who undergo the PT intervention will have a an assessment before and after the rehab TKA. Receives: Behavioral: Personalized outcome prediction tool + targeted interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction at 1 year
Patient Acceptable Symptom State (PASS) anchoring question of: "Taking into account all the activity you have during your daily life, your level of pain and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?" to measure satisfaction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start12 Mar 2024
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Responsible party
- Sponsor
- Investigators
- Nicolas S Piuzzi, MD, Principal investigator, Cleveland Clinic Ohio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298721
- Sponsor's protocol ID
- 23-885
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06298721
- Acronym / sponsor ID
- 23-885
- Conditions
- Knee Osteoarthritis, Knee Arthropathy, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American Association of Hip and Knee Surgeons
- Study start
- 12 Mar 2024 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 7 Mar 2024 (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.
This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).
Detailed description
The potential candidates for the study are patients scheduled for primary TKA. Scheduled patients will be sent an invitation letter detailing the study's objectives and design. Should they choose to take part, individuals will be requested to utilize MyChart for the completion of PROMs. The information gathered from these PROMs will play a pivotal role in assessing their suitability for inclusion in the study. Subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). This enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. Subsequently, enrolled patients will be randomized in a 1:1 ratio to:
- Standard of Care ii) Standard of Care + TKA Personalized Outcome Prediction Tool (Mental Health Screening/Intervention \& Physical Therapy Pre-surgery Assessments/Intervention)
TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will be provided and discussed with the patients by the surgeon.
The primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the PASS anchor question at 1-year postoperative. The treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. We will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care TKA | Active comparator | Behavioral: Standard of Care TKAPatients scheduled to undergo TKA at Cleveland Clinic will follow the standardized TKA Care Pathway as part of Standard of care. Patients enter the TKA care path after consenting to undergo TKA for symptomatic knee pain that has not relieved with nonoperative measures. They stay in the care path until 90-days after the operation is complete. The TKA care path guides the care delivered through the preoperative, intraoperative and postoperative phases. |
| Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions | Experimental | Behavioral: Personalized outcome prediction tool + targeted interventionsPatients who are identified to have a TKA PROMs phenotype which includes lower than median scores for VR-12 MCS will be further screened for: Distress ➔ using the NCCN Distress Thermometer (DT) Depression ➔ using the Patient Health Questionnaire-9 Those patients with a score ≥ 8 on the DT, or a score ≥ 10 on the PHQ-9, or any response other than 0 to question 9 on the PHQ-9 will have a consult with Psychiatry and Behavioral Science to determine a mental health diagnosis. Patients who are identified to have a TKA PROMS phenotype which includes lower than median scores for KOOS-PS (score of =<51.5) will be scheduled for a 4 to 8 week intervention of pre-rehabilitation. All patients who undergo the PT intervention will have a an assessment before and after the rehab TKA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult subject (Age >18 and < 80 years of age)
- The subject is proficient in the English language
- The patient is voluntarily prepared to sign the 'Informed Consent Form'
- The patient is scheduled for a unilateral primary TKA
- TKA PROMs Phenotypes with higher risk of dissatisfaction
Key exclusion criteria (5 listed)
- Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart
- Patients undergoing revision TKA
- Inflammatory arthritis
- History of infection in the joint undergoing TKA
- Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
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 |
|---|---|---|
| Personalized outcome prediction tool + targeted interventions* TKA Personalized Outcome Prediction Tool to aid in setting expectations * Mental Health Screening/Intervention * Physical Therapy Pre-surgery Assessments \& Rehabilitation | Behavioural | Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions |
| Standard of Care TKA- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent | Behavioural | Standard of Care TKA |
Primary outcome
Satisfaction at 1 year
Time frame: 1 year
Patient Acceptable Symptom State (PASS) anchoring question of: "Taking into account all the activity you have during your daily life, your level of pain and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?" to measure satisfaction
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 11 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Nicolas S Piuzzi, MD principal investigator
Cleveland Clinic Ohio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized outcome prediction tool + targeted interventions in people with Knee Osteoarthritis and Knee Arthropathy, run by The Cleveland Clinic at 1 site 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 6 inclusion and 5 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Shujaa T Khan, MD (4199658274, khans34@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction at 1 year (time frame: 1 year). 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 11 Jun 2026.