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

Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial

Who can join

Ages 18 to 80 · All sexes

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.)

About the study

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).

What is being tested

• Personalized outcome prediction tool + targeted interventions (behavioral)
• Standard of Care TKA (behavioral)

Sponsor: The Cleveland Clinic · Participants: 300 · Started: Mar 12, 2024

Contact the study team

• Shujaa T Khan, MD · Phone: 4199658274
• Alison Klika · Phone: 216 444-4954

Official record on ClinicalTrials.gov — NCT06298721

Locations in the U.S.

Conditions

• Knee Osteoarthritis

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.