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Clinical Trials in the USA / NCT06089291
Active, not recruiting Observational

Persona IQ Cohort Study

NCT06089291 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2024-02-20
Last updated
2026-06-04

Condition(s) studied

Osteo Arthritis KneeKnee ArthritisMonitoring Orthopedic DevicesTotal Knee ArthroplastyTotal Knee Replacement

Investigational drug(s) / intervention(s)

Persona IQ

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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.

Primary outcome measure(s)

  • mymobility platform data compared to most common AEs. — 6 months
    Assess the differences in episode of care, data compiled, collected, and delivered in the mymobility platform to correlate the incidence of nine most common post TKR medical complications. Nine most common post TKR medical complications: wound complication, thromboembolic disease, neural deficit, vascular injury, medial collateral ligament injury, instability, malalignment, stiffness, deep periprosthetic joint infection.
  • mymobility platform data compared to CTE/CSE data. — 6 months
    Comparison of mymobility platform data gait analysis to CTE data gait analysis.
  • Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data. — 90 days
    Functional ROM during a qualified gait cycle. Calculated from tibia ROM. Mean sagittal plane functional ROM when walking. Difference between maximum and minimum knee joint flexion.
  • mymobility platform data combined with CTE/CSE data compared to patient satisfaction at various intervals post op. — 6 months
    Assess the ability of post-op data compiled, collected, and delivered in the mymobility application (from, among other sources, the patient's smartphone sensors and Persona IQ implant data) collected during PODs 0-90 to predict which subjects will have a "very satisfied" or "satisfied" score on the Patient Satisfaction at 42 and 90-days. Potential Sources of Data: Smartphone Agnostic (iPhone or Android).Captures Google Fit steps from Android phone (and Fitbit, if data is imported to Google Fit app in Android application) as well as HealthKit Mobility Metrics from qualified iOS devices (steps, stairs, gait speed, asymmetry, etc.). Smartphone, Smartwatch, and PIQ activity dashboards displayed in surgeon/care team dashboard (Web or Mobile) and in patient app experience (Web or Mobile). Modular functionality allows care team to select content and management feature customization.

Trial sites (4)

FacilityCityRegionStatus
Jeffrey Yergler, LLC/South Bend Orthopaedics Granger Indiana
Washington University St Louis Missouri
OrthoCarolina Research Institute Charlotte North Carolina
Rothman Institute Philadelphia Pennsylvania

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06089291 on ClinicalTrials.gov ↗ ← All trials in the USA