Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Cleveland Clinic
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Personalized outcome prediction tool + targeted interventions
- Standard of Care TKA
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Cleveland Clinic
Lead sponsor
American Association of Hip and Knee Surgeons
Collaborator
Source ClinicalTrials.gov