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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-Long Term PAS


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General
Study Status Progress Adequate
Application Number P010014 / PAS001
Date Current Protocol Accepted 01/04/2013
Study Name OSB Lead-Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, non-randomized study to evaluate two-year post-operative complications among patients implanted with Oxford Meniscal Unicompartmental Knee System and 9-year long-term survivorship of the device.
Study Population Description This device is indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and intended to be implanted with bone cement. The study population includes patients who are 18 years or older, undergoing primary knee arthroplasty for either Osteoarthritis or Avascular necrosis of the medial compartment of the knee, and meet other inclusion/exclusion criteria will be included in this study.
Sample Size 389 knees
Data Collection For Phase 1 (0-2 years), the study endpoint is complications, which is defined as "Any untoward medical occurrence in a patient administered a medical device and which does not necessarily have to have a causal relationship with this treatment. For Phase II, the study endpoint is "removal and/or revision of any component of the device".
Follow-up Visits and Length of Follow-up In Phase 1, patients will be followed clinically at 6 weeks, 6 months, 1- year and 2- year post-operation. Information gathered includes all adverse events and survival data. In Phase II (3-9 year), only the device survival data will be gathered through patient direct mailing and/or phone call annually.


OSB Lead-Long Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year Report 04/18/2007 04/18/2007 On Time
2 year report 04/20/2008 04/29/2008 Overdue/Received
36 month report 04/20/2009 04/21/2009 Overdue/Received
5 year report 04/20/2010 05/03/2010 Overdue/Received
6 year report 06/21/2011 06/22/2011 Overdue/Received
7 year report 04/19/2012 04/19/2012 On Time
8 year report 04/19/2013 04/29/2013 Overdue/Received
9 year report 04/19/2014 04/21/2014 Overdue/Received
10 year report 04/18/2015 04/20/2015 Overdue/Received
11 year report 04/18/2016 04/19/2016 Overdue/Received
12 year report 04/18/2017 04/19/2017 Overdue/Received
13 year report 04/18/2018    


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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