f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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COC36 PAS: UK & Australian Natl Joint Reg


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General
Study Status Completed
Application Number /
Requirement Number		 P070026 S004/ PAS003
Date Original Protocol Accepted 04/02/2013
Date Current Protocol Accepted 11/21/2013
Study Name COC36 PAS: UK & Australian Natl Joint Reg
Device Name DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group No Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Objectives Hybrid non-comparator study based on registry data
Study Population 36mm CoC patients in UK and Australia joint registries
Sample Size At minimum 500 patients
Key Study Endpoints Device survivorship, revision and death rates
Follow-up Visits and Length of Follow-up N/A, the study duration is predicted to be 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 427 subjects with PMA approved components and indications from the United Kingdom National Joint Registry.
Actual Number of Sites Enrolled Not applicable as this is a retrospective registry analysis.
Patient Follow-up Rate Not applicable as this was a retrospective analysis.
Final Safety Findings Based on review of patients for between 0 and 11 years, 253 patients with 5 or more years follow-up, there was a revision rate of 0.77/100 patient years (95% confidence interval of 0.47-1.18). The estimated revision rate for patients at 7 years was 4.45% (95% confidence interval of 2.78-7.09%). Reasons for revision included infection, loosening, dislocation, pain and fracture.
Final Effect Findings The study collected only safety endpoints.
Study Strengths & Weaknesses The study evaluated the long term revision rate for patients; however, this study did not evaluate patient functional outcomes.
Recommendations for Labeling Changes no labeling changes recommended


COC36 PAS: UK & Australian Natl Joint Reg Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/01/2013 10/01/2013 On Time
one year report 04/02/2014 04/02/2014 On Time
18 month report 10/01/2014 10/01/2014 On Time
two year report 04/02/2015 03/31/2015 On Time
three year report 04/01/2016 04/01/2016 On Time
four year report 04/01/2017 04/03/2017 Overdue/Received
five year report/final report 04/01/2018 03/30/2018 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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