A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Total Knee Arthroplasty
- Registration Number
- NCT06040827
- Lead Sponsor
- Canary Medical
- 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:
Successful Data Collection
* Percent of days with step-count data transmitted
* Percent of days with one or more gait bouts triggered and transmitted
* Percent of days with qualified gait cycles \>0 (applicable for walking speed, stride length, tibia ROM, functional knee ROM and cadence)
* Percent of days with step-count data transmitted and qualified gait cycles \>0 (applicable for distance) Pain and Functional Performance
* Knee Injury and Osteoarthritis Outcome Score (KOOS - JR)
* Numeric Pain Rating Scale (NPRS)
* Quality-of-life- EQ-5D-5L
Effectiveness Endpoints (Reliability, Reproducibility, and Accuracy) The reliability, precision and accuracy of walking speed using measurements at 1 year and 2 years post TKA will be assessed with a cohort of 75 patients from Group 1 (with the CTE). Additionally, the reliability, precision and accuracy of all 7 gait parameters (walking speed, cadence, stride length, functional knee ROM, tibia ROM, step count and distance) using measurements at 1 year with 3 different walking speeds, will be assessed with a consecutive cohort of 25 patients from Group 1 in a gait lab.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 626
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 (Test) Total Knee Arthroplasty Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extension Group 2 ( Control) Total Knee Arthroplasty Group 2 (Control): Zimmer Persona® Personalized Knee System with 14 mm +30 mm stem extension
- Primary Outcome Measures
Name Time Method Safety - Adverse Events 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 Outcome Measures
Name Time Method Percent of days with step-count data transmitted 5 years post TKA Successful Data Collection
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 Successful Data Collection
Knee Injury and Osteoarthritis Outcome Score (KOOS - JR) 5 years post TKA Pain and Functional Performance
Numeric Pain Rating Scale (NPRS) 5 years post TKA Pain and Functional Performance
Percent of days with one or more gait bouts triggered and transmitted 5 years post TKA Successful Data Collection
Percent of days with step-count data transmitted and qualified gait cycles >0 (applicable for distance in meters) 5 years post TKA Successful Data Collection
Quality-of-life- EQ-5D-5L 5 years post TKA Pain and Functional Performance
Trial Locations
- Locations (7)
Ozark Orthopaedics
🇺🇸Fayetteville, Arkansas, United States
Foundation For Orthopaedic Research and Education
🇺🇸Tampa, Florida, United States
Northside Hospital
🇺🇸Atlanta, Georgia, United States
South Bend Orthopaedics
🇺🇸South Bend, Indiana, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
JIS Research Institute
🇺🇸New Albany, Ohio, United States
Carolina Orthopaedic & Neurosurgical Associates
🇺🇸Spartanburg, South Carolina, United States