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

Recruiting now · Not applicable

Conditions studied: Knee Osteoarthritis, Knee Arthropathy, Surgery

In brief

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).

Key facts

Study ID

NCT06298721

Run by

The Cleveland Clinic

People needed

300

Starts

2024-03-12

Expected to finish

2027-03-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subject (Age >18 and < 80 years of age)
• The subject is proficient in the English language
• The patient is voluntarily prepared to sign the 'Informed Consent Form'
• The patient is scheduled for a unilateral primary TKA
• TKA PROMs Phenotypes with higher risk of dissatisfaction
• Patient is willing and able to complete the protocol required follow-up

You may not qualify if…

• Patient requires simultaneous or staged bilateral knee replacements, staged <90 days apart
• Patients undergoing revision TKA
• Inflammatory arthritis
• History of infection in the joint undergoing TKA
• Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Where it is running

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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