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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

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Application Number P040048 / PAS001
Current Plan Approved 06/28/2006
Study Name OSB Lead-Long term
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 Design Description The post-approval study is a prospective, multi-center, uncontrolled cohort study of subjects in whom the device was implanted after FDA approval.

The purpose of the post-approval study is to evaluate the safety and effectiveness of the Trilogy AB Acetabular System through long-term follow-up of 10 years. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13,2010]. The description presented here is for the old study
Study Population Description Study population is as per device indication and it includes: age from 21 to 80 years, body mass index less than 30, willing and able to provide informed consent. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
Sample Size 250 patients
Data Collection Endpoints not mentioned
Follow-up Visits and Length of Follow-up During the first five years of the study clinical, radiographic, and subject self assessment information will be collected for each subject. Data will be collected pre-operatively, immediately post-operatively, at three months and annually up to five years. An independent radiographic review will be conducted at five years. For the sixth through the tenth postoperative years, patients will be asked to return an outcomes questionnaire designed to determine the status of their hip replacement. In addition, you have agreed to record and report each adverse event regarding full details of the nature of the complication, treatment and outcome on the appropriate Case Report Form. You will send in Interim Study Status Reports to the FDA every six months for the first two years of the study and annually thereafter until a Final Study Report has been submitted. The results of this long-term data must be reflected in the product labeling (via supplement) when the post-approval study is completed.
Final Study Results
Interim Safety Information Study being revised

OSB Lead-Long term Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 12/27/2006 01/08/2007 Overdue/Received
1 year report 06/28/2007 06/26/2007 On Time
18 month report 12/27/2007 12/26/2007 On Time
2 year report 07/24/2008 07/30/2008 On Time
3 year report 06/27/2009 06/23/2009 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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