Persona IQ Cohort Study

NCT06089291 | Enrolling By Invitation FDA Device

• 1 other identifier: CLU2021-46TDS
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Osteo Arthritis Knee; Knee Arthritis; Monitoring Orthopedic Devices; Total Knee Arthroplasty; Total Knee Replacement

Keywords

Cemented Primary Total Knee Arthroplasty; Medical Device; Performance; Safety; Persona IQ; Remote Therapeutic Monitoring; RTM; CTE; CSE; Smart Knee

Outcome Measures

Primary Outcomes (4)

• mymobility platform data compared to most common AEs.

  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.

  6 months

• mymobility platform data compared to CTE/CSE data.

  Comparison of mymobility platform data gait analysis to CTE data gait analysis.

  6 months

• Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.

  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.

  90 days

• mymobility platform data combined with CTE/CSE data compared to patient satisfaction at various intervals post op.

  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.

  6 months

Secondary Outcomes (2)

• Full patient clinical, mymobility platform data combined with CTE as it pertains to bearing variants at various intervals post op.

  6 months

• Full patient clinical, mymobility platform data combined with CTE data analysis for future product feature development.

  6 months

Other Outcomes (8)

• Implant survival measured in years.

  6 months

• Implant safety measured in frequency of adverse events.

  6 months

• Functional performance measured through patient reported outcome measures total scores via Knee Injury and Osteoarthritis Outcome Score - Short Form (KOOS, JR).

  6 months

Study Arms (1)

Persona IQ Cohort

The study device is intended to relieve pain and restore function in patients with adequate quality and quantity of bone stock to support the prosthesis. The device is indicated for use in patients undergoing a cemented TKA that are normally indicated for at least a 30 mm sized tibial stem extension and/or normally indicated for at least a 58mm sized tibial stem. To qualify to receive the CTE/CSE with CHIRP System, the patient must be a candidate for commercially available Persona IQ Personalized Knee System implanted in accordance with product labeling.

Device: Persona IQ

Interventions

Persona IQ DEVICE

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.

Persona IQ Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 30 mm sized tibial stem extension and/or normally indicated for at least a 58mm sized tibial stem extension. In order to qualify to receive the CTE/CSE with CHIRP system, the patient must meet the following requirements in addition to any requirements for TKA surgery as determined by the patient's surgeon: 1. The Patient's anatomy must be capable of accepting the Zimmer Biomet Persona Tibial Baseplate with CTE/CSE construct sizing. This assessment will be conducted pre-operatively by the surgeon using a CTE/CSE X-ray Template available through your Zimmer Biomet Representative. 2. The patient must have access to a computer with a USB connection to set up their Home Base Station or have access to a compatible smartphone to set up their Home Base Station (Bluetooth). 3. The Patient must have wireless internet in their domicile.

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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (4)

Jeffrey Yergler, LLC/South Bend Orthopaedics

Granger, Indiana, 46530, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• Erin Osborn

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: February 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (4)