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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US Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P040033 / PAS001
Date Original Protocol Accepted 05/09/2006
Date Current Protocol Accepted 04/01/2011
Study Name US Study
Device Name BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study design is a multi-center, single arm, prospective cohort study.
Study Population Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System, a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR System is intended for patients who, due to their relatively youneger age or increased activity level may not be suitable for traditional total hip arthroplasty, due to an increased possibility of requiring future ipsilatcral hip joint revision.
Sample Size The sample size is 350 patients.
Key Study Endpoints Study endpoints include Harris Hip Score and device survival.
Follow-up Visits and Length of Follow-up Patients will undergo clinical and radiographic examinations for the first five years of follow-up with a final clinical and radiographic examination at 10 years. Subjects will receive annual questionnaire follow-up in years 6 through 9.


US Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/07/2006 11/13/2006 Overdue/Received
1 year report 05/09/2007 05/08/2007 On Time
18 month report 11/07/2007 11/05/2007 On Time
2 year report 05/08/2008 05/06/2008 On Time
3 year report 07/08/2009 07/06/2009 On Time
4 year report 05/08/2010 05/06/2010 On Time
5 year report 07/07/2011 08/29/2011 Overdue/Received
6 year report 05/07/2012 05/07/2012 On Time
7 year report 05/07/2013 05/07/2013 On Time
8 year report 05/07/2014 05/06/2014 On Time
9 year report 05/07/2015 05/07/2015 On Time
10 year report 05/06/2016 05/06/2016 On Time
11 year report 05/06/2017 05/05/2017 On Time
12 year report 05/06/2018 05/03/2018 On Time
13 year report 05/06/2019 05/03/2019 On Time
14 year report 05/06/2020 06/03/2020 Overdue/Received
15 year report 05/06/2021 05/06/2021 On Time
16 year report 05/06/2022 05/05/2022 On Time
17 year report 05/06/2023 05/05/2023 On Time
18 year report 05/06/2024    


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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