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Persona IQ Cohort Study
Sponsor: Zimmer Biomet
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.
Official title: Persona IQ Cohort Study: A Multicentric Prospective Cohort Study of the Persona IQ® Personalized Knee System With the Mymobility® Care Management Application
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2024-02-20
Completion Date
2027-12
Last Updated
2026-03-03
Healthy Volunteers
No
Conditions
Interventions
Persona IQ
Persona IQ is a system comprised of the following subsystems: 1. RTM utilizing mymobility® patient application and care team dashboard, 2. PPK System with 3. CTE Extension Implant and Instrumentation, 1. Surgical Base Station System, 2. Home Base Station System, 3. Canary CDMP, 4. Canary CMGP software module, and 4. The ZBEdgeTM Connected Artificial Intelligence data platform. The system combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients.
Locations (4)
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