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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Personalized outcome prediction tool + targeted interventions
Behavioral* TKA Personalized Outcome Prediction Tool to aid in setting expectations * Mental Health Screening/Intervention * Physical Therapy Pre-surgery Assessments \& Rehabilitation
Standard of Care TKA
Behavioral\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Standard of Care TKAActive comparator 1 intervention
Group B: Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Satisfaction at 1 year
Patient Acceptable Symptom State (PASS) anchoring question of: "Taking into account all the activity you have during your daily life, your level of pain and also your activity limitations and participation restrictions, do you consider the current state of your knee satisfactory?" to measure satisfaction
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
American Association of Hip and Knee Surgeons
Collaborator
Source ClinicalTrials.gov