Persona IQ Cohort Study

Launched by ZIMMER BIOMET · Oct 11, 2023

Keywords

ClinConnect Summary

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 medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery.

The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 30...

Gender

ALL

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.