Surgery Clinical Trial - Improving Total Knee Arthroplasty Dissatisfaction

Status Recruiting

Clinical Trial 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).

Clinical Trial 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). 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06298721
Study type	Interventional
Source	The Cleveland Clinic
Contact	Shujaa T Khan, MD
Phone	4199658274
Email	khans34@ccf.org
Status	Recruiting
Phase	N/A
Start date	March 12, 2024
Completion date	March 2027

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms