RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-03-12
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06298721

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult subject (Age \>18 and \< 80 years of age)
  2. 2. The subject is proficient in the English language
  3. 3. The patient is voluntarily prepared to sign the 'Informed Consent Form'
  4. 4. The patient is scheduled for a unilateral primary TKA
  5. 5. TKA PROMs Phenotypes with higher risk of dissatisfaction
  6. 6. Patient is willing and able to complete the protocol required follow-up
  1. 1. Patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart
  2. 2. Patients undergoing revision TKA
  3. 3. Inflammatory arthritis
  4. 4. History of infection in the joint undergoing TKA
  5. 5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Contacts and Locations

Study Contact

Shujaa T Khan, MD
CONTACT
4199658274
khans34@ccf.org
Alison Klika
CONTACT
216 444-4954
klikaa@ccf.org

Principal Investigator

Nicolas S Piuzzi, MD
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Ohio

Study Locations (Sites)

Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Nicolas S Piuzzi, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Ohio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-12
Study Completion Date2027-03

Study Record Updates

Study Start Date2024-03-12
Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

  • Knee Osteoarthritis
  • Knee Arthropathy
  • Surgery