NCT06298721 Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
| NCT ID | NCT06298721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2024-03-12 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 standard of care).
Eligibility 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.)
Contact & Investigator
Nicolas S Piuzzi, MD
PRINCIPAL INVESTIGATOR
Cleveland Clinic Ohio
Frequently Asked Questions
Who can join the NCT06298721 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06298721 currently recruiting?
Yes, NCT06298721 is actively recruiting participants. Contact the research team at khans34@ccf.org for enrollment information.
Where is the NCT06298721 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06298721 clinical trial?
NCT06298721 is sponsored by The Cleveland Clinic. The principal investigator is Nicolas S Piuzzi, MD at Cleveland Clinic Ohio. The trial plans to enroll 300 participants.