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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT06298721
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

Start date
Mar 12, 2024
Status verified
Jun 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Satisfaction at 1 year [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FoundationClevelandOhio44195
Shujaa T Khan, MD
[email protected]
4199658274

Find similar trials in Cleveland, OH

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Cleveland Clinic Foundation· Cleveland, OH

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