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

Description

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

Knee Osteoarthritis, Knee Arthropathy, Surgery

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Knee Osteoarthritis
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.)

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Nicolas S Piuzzi, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Ohio

Study Record Dates

2027-03