Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298721
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-03-01
Brief Title:
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
The potential candidates for the study are patients scheduled for primary TKA Scheduled patients will be sent an invitation letter detailing the studys 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 11 ratio to
i Standard of Care ii Standard of Care TKA Personalized Outcome Prediction Tool Mental Health ScreeningIntervention Physical Therapy Pre-surgery AssessmentsIntervention
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 p005 as the threshold for statistical significance We will follow the intent-to-treat principle and patients assigned to the treatmentintervention arm will be analyzed as such regardless of hisher compliance with the intervention
i Standard of Care ii Standard of Care TKA Personalized Outcome Prediction Tool Mental Health ScreeningIntervention Physical Therapy Pre-surgery AssessmentsIntervention
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 p005 as the threshold for statistical significance We will follow the intent-to-treat principle and patients assigned to the treatmentintervention arm will be analyzed as such regardless of hisher compliance with the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None