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

NCT06298721 | Recruiting

• 1 other identifier: 23-885
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis; Knee Arthropathy; Surgery

Outcome Measures

Primary Outcomes (1)

• Satisfaction at 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

  1 year

Study Arms (2)

Standard of Care TKA

ACTIVE COMPARATOR

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.

Behavioral: Standard of Care TKA

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

EXPERIMENTAL

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.

Behavioral: Personalized outcome prediction tool + targeted interventions

Interventions

Personalized outcome prediction tool + targeted interventions BEHAVIORAL

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

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

Standard of Care TKA BEHAVIORAL

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

Standard of Care TKA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subject (Age \>18 and \< 80 years of age)
• The subject is proficient in the English language
• The patient is voluntarily prepared to sign the 'Informed Consent Form'
• The patient is scheduled for a unilateral primary TKA
• TKA PROMs Phenotypes with higher risk of dissatisfaction
• Patient is willing and able to complete the protocol required follow-up

You may not qualify if:

• Patient requires simultaneous or staged bilateral knee replacements, staged \<90 days apart
• Patients undergoing revision TKA
• Inflammatory arthritis
• History of infection in the joint undergoing TKA
• Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• American Association of Hip and Knee Surgeons: collaborator

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nicolas S Piuzzi, MD

  Cleveland Clinic Ohio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shujaa T Khan, MD

CONTACT

4199658274; khans34@ccf.org

Alison Klika

CONTACT

216 444-4954; klikaa@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: March 12, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)