f Post-Approval Studies (PAS) Database
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Australian Ortho Assc Natl Joint Registry


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Terminated
Application Number /
Requirement Number		 P040023 / PAS006
Date Original Protocol Accepted 04/20/2010
Date Current Protocol Accepted 04/20/2010
Study Name Australian Ortho Assc Natl Joint Registry
Device Name DURALOC OPTION CERAMIC HIP SYSTEM
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Registry study
Sample Size In the 2009 AOA-NJRR Annual Report there were 666 hips reportedly implanted with a DURALOC Option Metal Outer Shell in combination with an S-ROM femoral stem.
DePuy does not yet have confirmation on the number of ceramic-on-ceramic articulations.
However, based on internal data it is anticipated that approximately 450 hips will have ceramic on ceramic articulations.
Key Study Endpoints DePuy will provide the following information as the data exists and is permitted by the AOA-NJRR:

¿ Femoral Stem types
¿ The years in which the surgeries were performed
¿ Patient demographic summaries (age, gender, diagnosis, height, weight, BMI)
¿ Patient listing of reasons for revisions
¿ Revision rate
¿ Death rate
Follow-up Visits and Length of Follow-up The length of follow-up for this study is 10 years. DePuy will request annual ad-hoc reports from the AOA-NJRR and provide these reports to the FDA in annual progress reports.


Australian Ortho Assc Natl Joint Registry Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 04/20/2011 04/21/2011 Overdue/Received
2 year report 07/03/2012 06/26/2012 On Time
3 year report 05/17/2013 05/30/2013 Overdue/Received


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

-
-