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| General |
| Study Status |
Delayed |
| 522 Number / Requirement Number |
PS220001 / PSS001 |
| Date Original Plan Accepted |
03/24/2022
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| Date Current Plan Accepted |
09/28/2023
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| Study Name |
Study of Subjects with the CTE
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| Device Name |
Canary Tibial Extension (CTE) w/Canary Health Implanted Reporting Processor (CHIRP) System
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| Root Document Number |
DEN200064
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objectives of this study are to evaluate the safety, reliability, reproducibility, and accuracy, of the CTE with CHIRP System post-TKA.
The postmarket surveillance study will be a multicenter prospective observational cohort study to evaluate the safety profile of the CTE with CHIRP System. The nature, severity, and frequency of safety risks will be compared to those of TKA constructs utilizing a legally marketed Zimmer Persona® tibial stem extension used in primary TKA surgery. Safety will be evaluated in a study with two cohorts, treatment and control groups. Reliability, reproducibility, and accuracy will be evaluated in a focused gait analysis study in a subset of the treatment cohort.
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| Study Population |
Subject Group: Subjects with a Zimmer Persona® Personalized Knee System with Canary canturioTM (CTE) tibial extensions
Control Group: Subjects with a Zimmer Persona® Personalized Knee System with 14 mm x +30 mm stem extension.
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| Sample Size |
No. of subjects: 500 Total Subjects (250 subject; 250 control)
A maximum of six hundred and twenty-six (626) subjects, which accounts for a 20% attrition rate, will be enrolled in this study.
A second study (gait analysis) consisting of a subset of 100 subjects from the enrolled treated group (Group 1) will be performed to evaluate the reliability, reproducibility, and accuracy (effectiveness endpoints) of the pre-specified kinematic data elements provided by the CTE with CHIRP System compared to a valid comparator.
No. of sites: 6-10 sites. Sites location: US
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| Key Study Endpoints |
Safety Endpoint
The nature, severity, and frequency of safety risks in subjects with the Canary canturioTMte 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:
o Lytic lines (radiolucency greater than 2 mm in 2 or more zones)
o Focal lysis (progressive osteolytic lesion)
o Osteolysis (3 mm in more than 1 zone)
o Device fracture or failure (tibia only)
o Cortical thickening or periosteal reactions.
Effectiveness Endpoints (Subset of Group 1):
The effectiveness endpoints are
• The reliability, precision, and accuracy of walking speed at 1- and 2-years post TKA in a cohort of 75 patients from Group 1.
• The reliability, precision, accuracy of walking speed at 1 year of all 7 gait parameters (walking speed, cadence, stride length, functional knee ROM, tibia ROM, step count and distance) in a cohort of 25 patients from Group 1.
Secondary Endpoints
• 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
o Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)
o Numeric Pain Rating Scale (NPRS)
o Quality-of-life-EQ-5D-5L
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
No adverse events
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| Actual Number of Patients Enrolled |
46 subjects enrolled
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| Actual Number of Sites Enrolled |
Four (4)
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| Patient Followup Rate |
CTE Group: % Follow-up: 80% (4/5) (Actual/Expected) at 3 months.
Control Group: No subjects have reached the beginning of the 3-month study window.
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| Final Effectiveness Findings |
No primary effectiveness data reported.
Secondary endpoint data show successful data collection for the CTE Group and a decline in pain intensity with improvements in functional performance in both groups
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