Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
The Cleveland Clinic
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).
Description
The potential candidates for the study are patients scheduled for primary TKA. Scheduled patients will be sent an invitation letter detailing the study's objectives and design. Should they choose to take part, individuals will be requested to utilize MyChart for the completion of PROMs. The information gathered from these PROMs will play a pivotal role in assessing their suitability for inclusion in the study. Subsequently, once deemed eligible, our coordinator will arrange a convenient session to meticulously review and facilitate the signing of the informed consent form (enrollment visit). T…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult subject (Age \>18 and \< 80 years of age) 2. The subject is proficient in the English language 3. The patient is voluntarily prepared to sign the 'Informed Consent Form' 4. The patient is scheduled for a unilateral primary TKA 5. TKA PROMs Phenotypes with higher risk of dissatisfaction 6. Patient is willing and able to complete the protocol required follow-up Exclusion Criteria: 1. Patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart 2. Patients undergoing revision TKA 3. Inflammatory arthritis 4. History of infection in th…
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
Location
- Cleveland Clinic FoundationCleveland, Ohio