Persona IQ Cohort Study

Launched by ZIMMER BIOMET · Oct 11, 2023

Keywords

ClinConnect Summary

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. In addition to traditional data collection mechanisms, four passive outcome measures will be captured among all study subjects via the CTE sensors in combination with the mymobility App, attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. These correlative outcomes will be measured using qualified step counts, average walking speed, Tibial and Functional range of mo...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient must be 18 years of age or older.
• • Patient qualifies for primary unilateral or simultaneous bilateral total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis.
• • 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 a platform-compatible computer with USB connection and appropriate home wireless internet access.
• • Patient has access to the mymobility application via eligible smart phone.
• • 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 has undergone a contralateral knee replacement in the last 90 days or is scheduled for an upcoming contralateral knee replacement in the next 90 days.
• • 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 insufficient bone stock on femoral or tibial surfaces.
• • Patient has skeletal immaturity.
• • Patient has neuropathic arthropathy.
• • Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb.
• • Patient has severe instability secondary to the absence of collateral ligament integrity.
• • Patient has a stable, painless arthrodesis in a satisfactory functional position.
• • Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin.
• • Patient has gout, or a history of gout in the affected knee.
• • Patient has a known or suspected sensitivity to one or more of the implant materials.
• • Patient is undergoing procedures or treatments using ionizing radiation.
• • Patient anticipates exposure to electrical currents conducted or induced into the body (e.g., electrical stimulation)