Personalized approach to improve satisfaction after knee surgery
Official title: Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
Run by The Cleveland Clinic · NCT06298721 · Data updated 2026-11-12
This study is testing if using a personalized tool that includes mental health and physical therapy support can help people feel more satisfied after knee surgery compared to standard care alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | March 12, 2024 |
| Main results expected | March 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06298721 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 scheduled for unilateral primary TKA with higher risk of dissatisfaction.
✕Probably not a fit
Patients requiring simultaneous or staged bilateral knee replacements or those with inflammatory arthritis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial aims to enhance patient satisfaction following total knee arthroplasty (TKA) by implementing a Personalized Outcome Prediction Tool. Patients scheduled for primary TKA will be invited to participate and complete patient-reported outcome measures (PROMs) to assess their eligibility. Those who qualify will be randomized into two groups: one receiving standard care and the other receiving standard care plus the personalized tool, which includes mental health screenings and physical therapy assessments. The primary outcome will be measured by the proportion of patients who report dissatisfaction one year post-surgery.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient satisfaction and outcomes after knee surgery.
How similar studies have gone: Other studies have shown promise in using personalized approaches to improve surgical outcomes, suggesting potential success for this method.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult subject (Age \>18 and \< 80 years of age) 2. The subject is proficient in the English language 3. The patient is voluntarily prepared to sign the 'Informed Consent Form' 4. The patient is scheduled for a unilateral primary TKA 5. TKA PROMs Phenotypes with higher risk of dissatisfaction 6. Patient is willing and able to complete the protocol required follow-up Exclusion Criteria: 1. Patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart 2. Patients undergoing revision TKA 3. Inflammatory arthritis 4. History of infection in the joint undergoing TKA 5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)
Where it's running
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Cleveland Clinic Foundation
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Nicolas S Piuzzi, MD — Cleveland Clinic Ohio
- Study coordinator: Shujaa T Khan, MD
- Email: khans34@ccf.org
- Phone: 4199658274
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.