Actively Recruiting
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Led by The Cleveland Clinic · Updated on 2025-05-18
300
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
American Association of Hip and Knee Surgeons
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subject (Age >18 and < 80 years of age)
- Proficient in the English language
- Willing to voluntarily sign the Informed Consent Form
- Scheduled for a unilateral primary total knee arthroplasty (TKA)
- TKA PROMs phenotypes indicate higher risk of dissatisfaction
- Willing and able to complete all required follow-up procedures
You will not qualify if you...
- Requires simultaneous or staged bilateral knee replacements less than 90 days apart
- Undergoing revision total knee arthroplasty (TKA)
- Has inflammatory arthritis
- History of infection in the joint undergoing TKA
- Considered a member of a protected population (e.g., prisoner, mentally incompetent)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Shujaa T Khan, MD
CONTACT
A
Alison Klika
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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