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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

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

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Shujaa T Khan, MD419-965-8274khans34@ccf.org

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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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