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| General |
| Study Status |
Study Pending |
| 522 Number / Requirement Number |
PS220001 / PSS001 |
| Date Original Plan Accepted |
03/24/2022
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| Date Current Plan Accepted |
05/27/2022
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| Study Name |
Study of Subjects with the CTE Tibial Extension
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| Device Name |
Canary health implanted reporting processor
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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 |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The postmarket surveillance study will be a prospective observational cohort study to evaluate the safety profile of the CTE with CHIRP System in the intended patient population. A target sample size of 250 treated subjects and 250 control subjects, with a total maximum of 600 enrolled subjects to account for 20% attrition rate, will be used for evaluation. 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. The precision and accuracy of walking speed using measurements at 1-year and 2-year post TKA will be assessed with a cohort of 75 subjects. Additionally, the precision and accuracy of all 7 gait parameters using measurements at 1-year with 3 different walking speeds, will be assessed with a cohort of 25 subjects in a gait lab.
The objectives of this prospective observational cohort study are to evaluate the safety as well as the reliability, reproducibility, and accuracy, of the CTE with CHIRP System post-TKA in the intended use population. 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 (600) subjects, which accounts for a 20% attrition rate, will be enrolled in this study.
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.
Secondary Enpoints
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
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| Follow-up Visits and Length of Follow-up |
5 year follow-up
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