Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Recruiting · NCT06298721 · Interventional (participants receive a specific treatment) · Lead sponsor: The Cleveland Clinic
View the official record on ClinicalTrials.gov →Interventions studied
Personalized outcome prediction tool + targeted interventionsStandard of Care TKA
What this trial is about
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).
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed across 1 US state.
- Cleveland Clinic Foundation - Cleveland, Ohio, United States