• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

  • Print
  • Share
  • E-mail
-
The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

Learn more...

            
  To search for Manufacturer beginning with a specific letter, select that letter
 
 A 
 B 
 C 
 D 
 E 
 F 
 G 
 H 
 I 
 J 
 L 
 M 
 N 
 O 
 P 
 R 
 S 
 T 
 U 
 V 
 W 
 X 
 Z 
 
 
   

Study of Subjects with the CTE


 
Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Delayed
522 Number / Requirement Number PS220001 / PSS001
Date Original Plan Accepted 03/24/2022
Date Current Plan Accepted 09/28/2023
Study Name Study of Subjects with the CTE
Device Name Canary Tibial Extension (CTE) w/Canary Health Implanted Reporting Processor (CHIRP) System
Root Document Number DEN200064 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.
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.
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

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
Follow-up Visits and Length of Follow-up 5 years


Study of Subjects with the CTE Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 09/22/2022 09/21/2022 On Time
1 year report 03/24/2023 03/23/2023 On Time
18 month report 09/24/2023 09/19/2023 On Time
21 month report 12/24/2023 12/19/2023 On Time
2 year report 03/24/2024    
27 month report 06/24/2024    


-
-