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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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General
Application Number P050016 / PAS001
Current Plan Approved 11/04/2008
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 Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is a multi-center, non-randomized, cohort study, which includes the extended follow-up of the premarket cohort.
Study Population Description Study population is as per device indication.
Sample Size The sample size is up to 448 patients.
Data Collection Data collection includes patient demographic data and medical history. A functional evaluation will be performed including a Harris Hip Score. Radiographic examination will encompass anteroposterior (AP) and lateral plain film studies.
Follow-up Visits and Length of Follow-up Patients will receive clinical and radiographic examination at 3, 4, 5, 8 and 10 postoperative years. In addition, patients will receive brief questionnaires at 6, 7, and 9 postoperative years. For both primary efficacy endpoints (freedom from revision and composite clinical success) , the primary objective will be met by way of estimation using 95% exact binomial confidence intervals. Device survival will be illustrated by life tables and the plotting of a Kaplan-Meier curve.
Final Study Results
Interim Safety Information At 60 post-operative months, 94.5% of study participants attained a good-excellent Harris Hip Score.. Reported serious adverse events in the study population included 1 case of femoral fracture, 1 case of acetabular component loosening, and 1 case of dislocation.


OSB Lead-Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report (Long Term) 01/01/2008 01/02/2008 Overdue/Received
1 year report (Long Term) 07/02/2008 06/27/2008 On Time
18 month report (Long Term) 12/31/2008 12/31/2008 On Time
2 year report (Long Term) 07/02/2009 07/02/2009 On Time
3 year report (Long Term) 07/02/2010 07/01/2010 On Time
4 year report (Long Term) 07/02/2011 07/15/2011 Overdue/Received
5 year report (Long Term) 07/01/2012 07/20/2012 On Time
6 year report (Long Term) 07/01/2013 07/26/2013 Overdue/Received
7 year report (Long Term) 08/15/2014 08/07/2014 On Time
8 year report (Long Term) 08/17/2015 08/17/2015 On Time
Final Report 03/31/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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