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Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
RECRUITINGN/ASponsored by The Cleveland Clinic
Actively Recruiting
PhaseN/A
SponsorThe Cleveland Clinic
Started2024-03-12
Est. completion2027-03
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06298721
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
Age: 18 Years – 80 YearsHealthy volunteers accepted
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.)
Conditions4
ArthritisKnee ArthropathyKnee OsteoarthritisSurgery
Locations1 site
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
PhaseN/A
SponsorThe Cleveland Clinic
Started2024-03-12
Est. completion2027-03
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT06298721