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

NCT06298721 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-05-18

No results posted yet for this study

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).

Conditions

Interventions

BEHAVIORAL

Personalized 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

BEHAVIORAL

Standard of Care TKA

\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent

Sponsors & Collaborators

  • American Association of Hip and Knee Surgeons

    collaborator OTHER

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Nicolas S Piuzzi, MD · Cleveland Clinic Ohio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298721 on ClinicalTrials.gov