NCT06298721 · The Cleveland Clinic
Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
What this study is about
This study is a randomly assigned 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 the usual treatment).
View original scientific description
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).
Interventions
BEHAVIORAL
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
BEHAVIORAL
Standard of Care TKA
\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent
Primary outcome measures
Satisfaction at 1 year
Time frame: 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.)
Where
- Cleveland, Ohio
Collaborators
American Association of Hip and Knee Surgeons
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations