Status:
ENROLLING_BY_INVITATION
Persona IQ Cohort Study
Lead Sponsor:
Zimmer Biomet
Conditions:
Osteo Arthritis Knee
Knee Arthritis
Eligibility:
All Genders
18+ years
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 attem...
Detailed Description
The Canary Tibial Extension (CTE)/canturio Smart Extension (CSE) with Canary Health Implanted Reporting Processor (CHIRP) System are intended to provide objective kinematic data from the implanted med...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06089291
Start Date
February 20 2024
End Date
December 1 2027
Last Update
August 20 2025
Active Locations (4)
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1
Jeffrey Yergler, LLC/South Bend Orthopaedics
Granger, Indiana, United States, 46530
2
Washington University
St Louis, Missouri, United States, 63110
3
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
4
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107