Clinical trial for Knee Osteoarthritis
Official title Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes
ClinicalTrials.gov ID: NCT06298721
What this study is testing
- What it's testing
- The study wants to know whether using a tool that predicts outcomes and gives extra help to patients with low mental health or physical function can increase satisfaction one year after knee replacement.
- Who it's for
- People scheduled for total knee replacement surgery because of knee osteoarthritis.
- What's involved
- Participants are randomly assigned to get the prediction tool and targeted support, or to receive standard care. They will have the surgery, complete questionnaires, and attend follow‑up visits.
- Time commitment
- The study lasts about one year, with visits at the start, after surgery, and at follow‑up appointments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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.)
See the full eligibility 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
- 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.)
The study team makes the final eligibility decision.
Where it is enrolling
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Cleveland, Ohio, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.