Persona IQ Cohort Study
Running, not enrolling
Conditions studied: Osteo Arthritis Knee, Knee Arthritis, Monitoring Orthopedic Devices, Total Knee Arthroplasty, Total Knee Replacement
In brief
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.
Key facts
- Study ID
- NCT06089291
- Run by
- Zimmer Biomet
- People needed
- 200
- Starts
- 2024-02-20
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 local/systemic infection that may affect the prosthetic joint.
- Patient has Neuropathic Arthropathy.
- Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb, as determined by the Investigator.
- Patient has gout, or a history of gout in the affected knee.
- Patient is undergoing procedures or treatments using ionizing radiation at or in the proximity of the CTE/CSE.
- Off-label use or not according to the approved instructions for use (IFU) of study devices.
Where it is running
- Jeffrey Yergler, LLC/South Bend Orthopaedics — Granger, Indiana, United States
- Washington University — St Louis, Missouri, United States
- OrthoCarolina Research Institute — Charlotte, North Carolina, United States
- Rothman Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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