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

NCT ID: NCT06298721

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-12
• Study Completion Date: 2027-03-31

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 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.

Conditions

Knee Osteoarthritis; Knee Arthropathy; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care TKA

Patients scheduled to undergo TKA at Cleveland Clinic will follow the standardized TKA Care Pathway as part of Standard of care. Patients enter the TKA care path after consenting to undergo TKA for symptomatic knee pain that has not relieved with nonoperative measures. They stay in the care path until 90-days after the operation is complete. The TKA care path guides the care delivered through the preoperative, intraoperative and postoperative phases.

Group Type: ACTIVE_COMPARATOR

Standard of Care TKA

Intervention Type: BEHAVIORAL

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

Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions

Patients who are identified to have a TKA PROMs phenotype which includes lower than median scores for VR-12 MCS will be further screened for:

Distress ➔ using the NCCN Distress Thermometer (DT) Depression ➔ using the Patient Health Questionnaire-9 Those patients with a score ≥ 8 on the DT, or a score ≥ 10 on the PHQ-9, or any response other than 0 to question 9 on the PHQ-9 will have a consult with Psychiatry and Behavioral Science to determine a mental health diagnosis.

Patients who are identified to have a TKA PROMS phenotype which includes lower than median scores for KOOS-PS (score of =<51.5) will be scheduled for a 4 to 8 week intervention of pre-rehabilitation. All patients who undergo the PT intervention will have a an assessment before and after the rehab TKA.

Group Type: EXPERIMENTAL

Personalized outcome prediction tool + targeted interventions

Intervention Type: BEHAVIORAL

• TKA Personalized Outcome Prediction Tool to aid in setting expectations
• Mental Health Screening/Intervention
• Physical Therapy Pre-surgery Assessments & Rehabilitation

Interventions

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

Intervention Type: BEHAVIORAL

Standard of Care TKA

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 the joint undergoing TKA

5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Association of Hip and Knee Surgeons

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas S Piuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Ohio

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shujaa T Khan, MD

Role: CONTACT

khans34@ccf.org

4199658274

Alison Klika

Role: CONTACT

klikaa@ccf.org

216 444-4954

Facility Contacts

Shujaa T Khan, MD

Role: primary

khans34@ccf.org

419-965-8274

Other Identifiers

23-885

Identifier Type: -

Identifier Source: org_study_id