Actively Recruiting
Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial
Led by The Cleveland Clinic · Updated on 2025-05-18
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
A
American Association of Hip and Knee Surgeons
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether using a personalized outcome prediction tool combined with targeted interventions for patients undergoing primary total knee arthroplasty (TKA) can improve patient satisfaction one year after surgery compared to standard care. This study focuses on patients with knee osteoarthritis or arthropathy who are scheduled for unilateral primary TKA and have specific patient-reported outcome measure (PROM) phenotypes associated with higher dissatisfaction risk. The trial is designed as a randomized controlled study to assess the impact of setting expectations and addressing mental health and physical function before surgery. Participants will be randomly assigned to one of two groups. The control group will receive standard preoperative care following the typical TKA care pathway. The intervention group will receive the standard care plus the personalized prediction tool, which helps set surgery expectations based on patient information and baseline PROMs. Those in the intervention group identified with poor mental health will undergo mental health screening and possible consultation, while patients with poor physical function will be scheduled for 4 to 8 weeks of pre-surgery physical therapy. Both groups will follow their respective care paths from enrollment about 2-3 months before surgery until 90 days post-operation. During the study, participants will complete PROMs via MyChart to assess eligibility and track outcomes. Researchers will measure satisfaction at one year after surgery using a patient-acceptable symptom state (PASS) question. The study will analyze treatment success by comparing the proportion of patients dissatisfied at one year between groups. Participants will be monitored through regular follow-ups, including mental health assessments, physical therapy evaluations, and standard clinical care evaluations. The total involvement spans from enrollment before surgery to the postoperative follow-up period.
CONDITIONS
Brief Title
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 and under 80 years
- Proficient in the English language
- Voluntarily prepared to sign the informed consent form
- Scheduled for unilateral primary total knee arthroplasty (TKA)
- Have TKA PROMs phenotypes associated with higher risk of dissatisfaction
- Willing and able to complete required follow-up as per protocol
You will not qualify if you...
- Require simultaneous or staged bilateral knee replacements within less than 90 days
- Undergoing revision total knee arthroplasty
- Have inflammatory arthritis
- History of infection in the joint undergoing TKA
- Considered a member of a protected population (e.g., prisoner, mentally incompetent)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Eligible participants meet with the study coordinator to review and sign the informed consent form approximately 2 to 3 months prior to surgery.
1 enrollment visit (in-person)
Duration - Approximately 2 to 3 months before surgery
Participants receive standard care for total knee arthroplasty (TKA). Those randomized to the intervention arm also receive personalized outcome prediction, mental health screening/intervention, and physical therapy pre-surgery assessments and rehabilitation lasting 4 to 8 weeks before surgery.
Multiple visits based on intervention assignment including pre-surgery assessments and rehabilitation
Duration - 1 day
Participants undergo primary total knee arthroplasty surgery.
1 surgery day visit
Duration - 1 year post-surgery
Participants are monitored and assessed for outcomes including satisfaction at 1 year after surgery.
Follow-up visits as per standard care up to 1 year
Trial Site Locations
Total: 1 location
1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
S
Shujaa T Khan, MD
A
Alison Klika
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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