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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-US Study

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Application Number P040033 / PAS001
Current Plan Approved 05/09/2006
Study Name OSB Lead-US Study
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 Design Description The study design is a multi-center, single arm, prospective cohort study.
Study Population Description 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.
Data Collection 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.
Final Study Results
Interim Safety Information There have been a total of 36 adverse events. There have been no deaths and 4 revisions since the study started. There have been no deaths and 1 revision during this reporting period.

OSB Lead-US Study Schedule

Report Schedule
Date Due
FDA Receipt
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    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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