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Clinical Trial NCT06298721 for Knee Osteoarthritis, Knee Arthropathy, Surgery is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes 300 Randomized Personalized Treatment

Recruiting
Clinical Trial NCT06298721 is an interventional study for Knee Osteoarthritis, Knee Arthropathy, Surgery that is recruiting. It started on 12 March 2024 with plans to enroll 300 participants. Led by The Cleveland Clinic, it is expected to complete by 1 March 2027. The latest data from ClinicalTrials.gov was last updated on 18 May 2025.
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. Subseq...Show More
Official Title

Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial

Conditions
Knee OsteoarthritisKnee ArthropathySurgery
Other Study IDs
  • 23-885
NCT ID Number
NCT06298721
Start Date (Actual)
2024-03-12
Last Update Posted
2025-05-18
Completion Date (Estimated)
2027-03
Enrollment (Estimated)
300
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorStandard 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, intrao...Show More
Standard of Care TKA
\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent
ExperimentalStandard 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 Be...Show More
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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.)
The Cleveland Clinic logoThe Cleveland Clinic
American Association of Hip and Knee Surgeons logoAmerican Association of Hip and Knee Surgeons
Study Central Contact
Contact: Shujaa T Khan, MD, 4199658274, [email protected]
Contact: Alison Klika, 216 444-4954, [email protected]
1 Study Locations in 1 Countries

Ohio

Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States
Shujaa T Khan, MD, Contact, 419-965-8274, [email protected]
Recruiting