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NCT06089291

Persona IQ Cohort Study

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

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

Interventions

DEVICE

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