f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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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Prospective Post-Approval Study


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General
Study Status Terminated
Application Number /
Requirement Number		 P040023 / PAS002
Date Original Protocol Accepted 04/20/2010
Date Current Protocol Accepted 04/20/2010
Study Name Prospective Post-Approval Study
Device Name DURALOC OPTION CERAMIC HIP SYSTEM
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 Objectives The Prospective Post-Approval Study is a single-arm observational study
Sample Size Approximately 100 qualified subjects, at up to 10 centers, previously enrolled in the original prospective post-approval study will be longitudinally followed after their primary total hip replacement surgery.
Key Study Endpoints Clinical data (hip function), radiographic evaluations, an outcomes questionnaire, and subject self-assessment information was/will be collected for each subject. Key endpoints include device survival, Harris Hip Score, and radiographic assessment.
Follow-up Visits and Length of Follow-up The length of follow-up for this study is 5 years. A quality of life survey (SF-12) was/will be completed by the subject for all post-operative visits up to the 5-year follow-up interval. The Subject Outcomes Questionnaire was/will be completed by the subject at the one year follow-up interval and annually after that up to the 5-year follow-up interval. The (modified Harris) Hip Function Evaluation was/will be used to clinically assess each subject pre-operatively, and at 6 weeks, 6 months, and annually for five years postoperatively. High quality anteroposterior pelvis (AP-pelvis) and lateral radiographs of the operative hip were/will be obtained during the same postoperative follow-up intervals as for the clinical evaluations.


Prospective Post-Approval Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
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 05/20/2013 Overdue/Received


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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