Persona IQ Cohort Study (NCT06089291) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Persona IQ Cohort Study
United States200 participantsStarted 2024-02-20
Plain-language summary
A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. Specifically comparing kinematic metrics captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturio te (CTE) and canturio se (CSE) sensors in combination with the mymobility® App.
The purpose of this study is to evaluate safety, functional performance, and effectiveness of the implant.
Primary Objective:
Assess Persona IQ kinematic metrics captured via the CTE/CSE sensor to assist surgeons in understanding and managing recovery through post-operative gait metrics.
Secondary Objective:
Evaluate the value of Remote Therapeutic Monitoring (RTM) and healthcare utilization.
Exploratory Objective:
Exploratory analyses will be performed using these data to direct future product feature development, data algorithm products, and research. This includes but is not limited to participants implanted utilizing ROSA® Robotics and other ZBEdge technologies.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Patient must be 18 years of age or older.
* Patient qualifies for primary unilateral, staged bilateral or simultaneous bilateral total knee arthroplasty.
* Independent of study participation, patient is a candidate for commercially available Persona IQ Personalized Knee System implanted in accordance with product labeling.
* Patient has access to appropriate technology to ensure full functionality for the home base station used as a part of their study procedure.
* Patient has access to the mymobility platform via eligible smart device.
* Patient must be willing and able to complete the protocol required follow-up.
* Patient is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB approved Informed Consent and Authorization form.
* Patient is able to read and understand the language used in the mymobility app for their region.
Exclusion Criteria
* Patient is a current alcohol or drug abuser.
* Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.).
* Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program.
* Patient is currently participating in any other surgical intervention study which would compromise the results of this study, as determined by the Investigator.
* Patient has previous history of infection in the affected joint and/or other l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
mymobility platform data compared to most common AEs.
Timeframe: 6 months
2
mymobility platform data compared to CTE/CSE data.
Timeframe: 6 months
3
Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.
Timeframe: 90 days
4
mymobility platform data combined with CTE/CSE data compared to patient satisfaction at various intervals post op.