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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-Duraloc Long Term


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General
Application Number P040023 / PAS001
Current Plan Approved 05/03/2005
Study Name OSB Lead-Duraloc 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, uncontrolled multi-center study that is designed to evaluate the long-term safety and effectiveness of the Duraloc Option Ceramic Hip. 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 as per device indication. This device is indicated for non-cemented use in primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis.
Sample Size A total of 250 patients 10 clinical centers
Data Collection Key endpoints include device survival, Harris Hip Score, and radiographic assessment. During the final 5 years of patient follow-up, patients will only complete a mailed outcomes questionnaire that will inquire regarding device survival and patient satisfaction.
Follow-up Visits and Length of Follow-up Each patient will be followed for 10 years. During the first 5 years of patient follow-up, patients will undergo clinical and radiographic examination as well as complete an outcomes questionnaire.
Final Study Results
Interim Safety Information Study is being revised


OSB Lead-Duraloc Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Study Initiation report 11/10/2005 11/10/2005 On Time
1 year report 05/03/2006 07/25/2006 Overdue/Received
2 year report 07/03/2007 07/16/2007 Overdue/Received
Adverse Device Report 01/15/2008 01/15/2008 On Time
3 year report 05/02/2008 05/07/2008 Overdue/Received
4 year report 07/29/2009 08/04/2009 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
20993-0002

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

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