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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-DePuy Outcome Tracking Sys Registry(DOTS)

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Study Status Terminated
Application Number P040023 / PAS003
Date Current Protocol Accepted 04/20/2010
Study Name OSB Lead-DePuy Outcome Tracking Sys Registry(DOTS)
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 Approximately 80 subjects at multiple clinical sites who have previously received a DURALOC Option implant will be longitudinally followed after their primary total hip replacement surgery.

Data Collection DePuy will provide annual reports from the DOTS registry patients and provide these reports to the FDA in annual progress reports. DePuy will provide the following information:

¿ 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.

OSB Lead-DePuy Outcome Tracking Sys Registry(DOTS) 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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