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

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OSB Lead-New Enrollment

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Study Status Completed
Application Number P050016 / PAS002
Date Current Protocol Accepted 11/04/2008
Study Name OSB Lead-New Enrollment
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical 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, prospective cohort study. The first null hypothesis of the study is that the 24 month cumulative revision rate is more than 0.126. The second null hypothesis is that the 24 month composite clinical success rate is less than 0.81.
Study Population Description Study population is as per device indication.
Sample Size The sample size is 160 procedures.
Data Collection 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.
Follow-up Visits and Length of Follow-up Patients will be evaluated preoperatively, and at 6 weeks, 6 months, 12 months and 24 months postoperatively. The length of patient follow-up is two years.
Interim or Final Data Summary
Interim Safety Information Good-excellent Harris Hip Scores were obtained by 95.2% of study participants at 6 post-opertaive months and 97.4% at 12 post-operative months. Two cases of femoral neck fracture were reported.
Actual Number of Patients Enrolled A total of 147 patients and 160 hips were enrolled in the study.
Actual Number of Sites Enrolled A total of six study sites enrolled patients into the study.
Patient Follow-up Rate Follow-up in the study was 81.8% at 24+months.
Final Safety Findings The percentage of study subjects who achieved Composite Clinical Success (CCS), 92.5%, in the unilateral analysis groups for the Post-Approval (PAS) study was higher than that for the Pre-Market study,


Final Effect Findings A pronounced increased in Harris Hip Scores, a measure of device effectiveness, was observed post- operatively. The mean Harris Hip Score pre-operatively was 53.9 for unilateral patients and 60.2 for bilateral patients. The mean Harris Hip Score at 24+ post-operative months was 96.1 for unilateral patients and 93.5 for bilateral patients.
Study Strengths & Weaknesses A strength of the study was that it was appropriately powered for the study endpoints. An additional strength of the study was the fact that a broad cross-section of clinical sites participated in the study. A study weakness was the absence of a concurrent control group.
Recommendations for Labeling Changes Labeling changes are recommended. The sponsor should be instructed to submit a labeling change supplement for the post-approval study that encompasses the findings regarding the post-approval study that are delineated above.

OSB Lead-New Enrollment Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report (New Enrollment) 07/02/2008 06/27/2008 On Time
18 month report (New Enrollment) 12/31/2008 12/31/2008 On Time
21 month report (New Enrollment) 03/31/2009 03/31/2009 On Time
2 year report (New Enrollment) 07/02/2009 07/01/2009 On Time
27 month report (New Enrollment) 10/01/2009 10/01/2009 On Time
30 month report (New Enrollment) 01/05/2010 01/05/2010 On Time
33 month report 04/05/2010 04/02/2010 On Time
3 year report (New Enrollment) 07/02/2010 07/01/2010 On Time
39 month report 09/30/2010 09/30/2010 On Time
42 month report 12/29/2010 12/29/2010 On Time
45 month report 04/01/2011 04/01/2011 On Time
4 year report 07/02/2011 07/11/2011 Overdue/Received
51 month report 10/01/2011 09/29/2011 On Time
54 month report 12/31/2011 12/29/2011 On Time
5 year report 07/01/2012 07/09/2012 Overdue/Received
6 year report 07/01/2013 06/20/2013 On Time
Final report 08/15/2014 08/15/2014 On Time
response to R34 (final report) 03/20/2015 03/13/2015 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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