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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-Kaiser Permanente Joint Registry

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Application Number P040023 / PAS004
Current Plan Approved 04/20/2010
Study Name OSB Lead-Kaiser Permanente Joint Registry
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Registry study
Sample Size Kaiser has identified approximately 90 patients at multiple clinical sites in their total joint registry that have DURALOC Option ceramic on ceramic hip replacements.

Data Collection Depuy will provide the following information as the data exists and is permitted by Kaiser Permanente:

¿ Femoral Stem types

¿ The years in which the surgeries were performed

¿ Patient demographic summaries (age, gender, diagnosis, height, weight, BMI)

¿ Patient listing of reasons for revisions

¿ Revision rate

¿ Death rate

¿ Kaplan-Meier survival estimates

¿ Harris Hip Score over time

¿ Adverse Events

¿ Radiographic results

Follow-up Visits and Length of Follow-up The length of follow-up for this study is 5 years. Pending contract execution, Depuy will request that Kaiser recall these patients for annual follow-up visits.

OSB Lead-Kaiser Permanente Joint Registry Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year report 04/20/2011 04/21/2011 Overdue/Received
2 year report 07/03/2012 06/26/2012 On Time
3 year report 05/17/2013 05/30/2013 Overdue/Received

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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