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Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes

RecruitingNAAges 18 Years - 80 YearsAllThe Cleveland Clinic
NCT06298721 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.)
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What it tests

  • Personalized outcome prediction tool + targeted interventions
  • Standard of Care TKA
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Where

1 site
Cleveland Clinic Foundation
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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