Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT06298721
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).
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
Location status: Recruiting
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). This enrollment visit will take place approximately 2-3 months prior to the scheduled surgery. Subsequently, enrolled patients will be randomized in a 1:1 ratio to:
i) Standard of Care ii) Standard of Care + TKA Personalized Outcome Prediction Tool (Mental Health Screening/Intervention & Physical Therapy Pre-surgery Assessments/Intervention)
TKA Personalized Outcome Prediction Tool aids in setting expectations for surgery and the results (calculated from patient information and baseline PROMs) will be provided and discussed with the patients by the surgeon.
The primary outcome of the study will be the proportion of patients who fail treatment, defined as patients who answer "no" to the PASS anchor question at 1-year postoperative. The treatment and control groups will be compared using a chi-square test between the randomized groups with p=0.05 as the threshold for statistical significance. We will follow the intent-to-treat principle, and patients assigned to the treatment/intervention arm will be analyzed as such regardless of his/her compliance with the intervention.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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
Contact information is provided by the study sponsor or research team.
Alison Klika
CONTACT
Shujaa T Khan, MD
CONTACT
The Cleveland Clinic
Other
Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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