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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-Trilogy PAS


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General
Application Number P040048 / PAS002
Current Plan Approved 06/04/2010
Study Name OSB Lead-Trilogy PAS
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Mixed retrospective and prospective cohort
Study Population Description Trilogy AB Acetabular System hip implant recipients -- All patients eligible to receive a primary Zimmer trilogy AB acetabular shell, BIOLOX forte ceramic liner, and a BIOLOX forte ceramic head
Sample Size 250 patients
Data Collection 1) Harris Hip Score

2) Device survivorship

3) Radiographic parameters (e.g. cup migration)
Follow-up Visits and Length of Follow-up 10 years


OSB Lead-Trilogy PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/01/2010 12/01/2010 On Time
one year report 06/04/2011 06/02/2011 On Time
18 month report 12/01/2011 11/30/2011 On Time
two year report-final report 09/01/2012 08/29/2012 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
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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