Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT06298721

Conditions

Knee Osteoarthritis

Knee Arthropathy

Surgery

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Personalized outcome prediction tool + targeted interventions

Standard of Care TKA

Study Details

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

Study ID

NCT06298721

Start date

Mar 12, 2024

Status verified date

Jun, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

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

Standard of Care TKA

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

Primary outcome measure

  • Satisfaction at 1 year [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Shujaa T Khan, MD

4199658274khans34@ccf.org

Alison Klika

216 444-4954klikaa@ccf.org

Locations

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Shujaa T Khan, MD

4199658274khans34@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-11.