A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Ext… (NCT06040827) | Clinical Trial Compass
RecruitingNot Applicable
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
United States626 participantsStarted 2023-09-12
Plain-language summary
The objectives of this prospective observational cohort study are to evaluate the safety, reliability, reproducibility, and accuracy of the Canary canturioTM te post-TKA.
Who can participate
Age range18 Years
SexALL
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Inclusion
* Patient must be 18 years of age or older
* Patient qualifies for primary total knee arthroplasty based on physical exam and medical history, including diagnosis of severe knee pain and disability due to osteoarthritis, limited to:
* Mild or Moderate valgus, varus, or flexion deformities
* Patient must be willing and able to complete the protocol required follow-up
* Patient is indicated for a 58mm or 30mm tibial stem extension
* Patient has participated in the study-related informed consent process
* Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
* Patient has a platform-compatible personal computer located in their dwelling with appropriate wireless internet access and a USB port
* Independent of study participation, patient is a candidate for commercially available Persona Personalized Knee System implanted in accordance with product labeling
Exclusion
* Simultaneous bilateral TKA
* Staged bilateral TKA less than 6 months from indexed procedure
* 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 has previous history of infection in the affected joint and/or a local or systemic infection that may affect the pro…