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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-Long Term Study

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Application Number P050009 / PAS001
Current Plan Approved 12/16/2005
Study Name OSB Lead-Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is single-arm, prospective cohort. There are no formal study hypotheses. 10 year post-marketing prospective hip study enrolling a minimum of 257 primary total hip replacements of whom a minimum of 160 will be followed out to 5 years and a minimum of 100 patients will be followed for 10 years. The first phase of the investigation will gather clinical, radiographic, and survivorship data for 5 years following implantation. The second phase, years 6 through 10, will utilize mailings to gather survivorship information. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13, 2010]. The description presented here is for the old study
Study Population Description Patients who underwent total hip arthroplasty using a C2 a-Taper Acetabular System ceramic on ceramic hip articulating system.
Sample Size The sample size is 257 patients.
Data Collection Study endpoints include device revision and Harris Hip Score during the first five years of follow-up.
Follow-up Visits and Length of Follow-up Patients will undergo clinical and radiographic examination for their first five years of follow-up. During their last 5 years of follow-up patients will receive annual questionnaires regarding the status of their total hip replacements.
Final Study Results
Interim Safety Information Study is being revised

OSB Lead-Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 12/16/2006 12/15/2006 On Time
2 year report 12/16/2007 12/17/2007 Overdue/Received
3 year report 12/15/2008 12/17/2008 Overdue/Received
4 year report 12/15/2009 12/10/2009 On Time
5 year report 12/15/2010 12/15/2010 On Time
6 year report 12/15/2011 12/15/2011 On Time
7 year report 12/14/2012 12/10/2012 On Time
8 year report 12/14/2013 12/19/2013 Overdue/Received
9 year report 12/14/2014 12/12/2014 On Time

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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