A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 626
- Locations
- 7
- Primary Endpoint
- Safety - Adverse Events
Study Overview
Brief 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.
Detailed 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 (tibia only)
- Aseptic loosening
- Instability (or unrecognized septic loosening)
- Intra-operative fracture of bone or device
- Post-operative fracture of bone or device
- Radiologic changes including:
- Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
- Focal lysis(progressive osteolytic lesion)
- Osteolysis (3mm in more than 1 zone)
- Device fracture or failure (tibia only)
- Cortical thickening or periosteal reactions
Secondary Endpoints
The secondary endpoints (for 5 years post-TKA) are:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety - Adverse Events
Time Frame: 5 years post TKA
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.
Secondary Outcomes
- Percent of days with step-count data transmitted(5 years post TKA)
- Percent of days with qualified gait cycles >0 (applicable for walking speed meter/second, stride length meter, tibia ROM, functional knee ROM and cadence)(5 years post TKA)
- Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)(5 years post TKA)
- Numeric Pain Rating Scale (NPRS)(5 years post TKA)
- Percent of days with one or more gait bouts triggered and transmitted(5 years post TKA)
- Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters)(5 years post TKA)
- Quality-of-life- EQ-5D-5L(5 years post TKA)