Persona IQ Cohort Study

Launched by ZIMMER BIOMET · Oct 11, 2023

Keywords

ClinConnect Summary

This is a multicenter, observational study (not a randomized trial) looking at the Zimmer Biomet Persona IQ knee system with the mymobility app. Researchers will follow a large group of adults who are getting a cemented total knee replacement to see how well the knee and the related remote monitoring tools work in real life. They’ll collect walking and movement data from sensors, plus patient-reported measures of pain, function, and quality of life, over about a year. The study aims to see if the data from the mymobility app and sensors can describe recovery, predict outcomes like satisfaction and function, and how much health care is used after surgery.

If you’re eligible, you would be 18 or older and a candidate for a cemented total knee replacement that fits the Persona IQ system. You’d need access to a compatible smartphone or home base station and be willing to use the mymobility app and complete follow‑up visits. Key things that could affect eligibility include factors like active joint infection, certain medical conditions, pregnancy, or inability to participate in follow-up. The study is enrolling by invitation and plans to include about 1,000 participants. Follow-ups are scheduled around 1 month, 3 months, and 1 year after surgery (the 1‑year visit is optional). Data from your visits, the app, and sensors will be collected for research and may inform future product improvements.

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.