Persona IQ Cohort Study: A Multicentric Prospective Cohort Study of the Persona IQ® Personalized Knee System With the Mymobility® Care Management Application
Trial ID: NCT06089291
Status: ENROLLING_BY_INVITATION
Study type: OBSERVATIONAL
Start date: 2024-02-20
Completion date: 2026-12
Sponsor: Zimmer Biomet
Conditions: Osteo Arthritis Knee; Knee Arthritis; Monitoring Orthopedic Devices; Total Knee Arthroplasty; Total Knee Replacement
Interventions: Persona IQ
Locations: Jeffrey Yergler, LLC/South Bend Orthopaedics; Washington University; OrthoCarolina Research Institute; Rothman Institute
Countries: United States; United States; United States; United States
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

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 criteria:
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.

Outcomes:
mymobility platform data compared to most common AEs.; mymobility platform data compared to CTE/CSE data.; Identify 14 to 30-days Persona IQ data points which correlate with 90-days post op full, arthrokinematic sagittal ROM data.; mymobility platform data combined with CTE/CSE data compared to patient satisfaction at various intervals post op.