RecruitingNot ApplicableNCT06298721

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


Sponsor

The Cleveland Clinic

Enrollment

300 participants

Start Date

Mar 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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

Exclusion Criteria5

  • 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.)

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Interventions

BEHAVIORALPersonalized outcome prediction tool + targeted interventions

* TKA Personalized Outcome Prediction Tool to aid in setting expectations * Mental Health Screening/Intervention * Physical Therapy Pre-surgery Assessments \& Rehabilitation

BEHAVIORALStandard of Care TKA

\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent


Locations(1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States

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NCT06298721


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