A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Canary Medical
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.
Description
Group 1 (Test): Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension Safety Endpoint The nature, severity, and frequency of safety risks in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA. The safety endpoint is the percentage of patients that meet any of the following criteria within 5 years post-TKA: * Revision (tib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 da…
Interventions
- DeviceTotal Knee Arthroplasty
The nature, severity, and frequency of safety risks (Adverse Events) in subjects with the Canary canturioTM te will be compared to those subjects with the legally marketed Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension within 5 years post-TKA.
Locations (7)
- Ozark OrthopaedicsFayetteville, Arkansas
- Foundation For Orthopaedic Research and EducationTampa, Florida
- Northside HospitalAtlanta, Georgia
- South Bend OrthopaedicsSouth Bend, Indiana
- Cleveland ClinicCleveland, Ohio
- JIS Research InstituteNew Albany, Ohio