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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 Study


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General
Application Number P060023 / PAS001
Current Plan Approved 05/12/2009
Study Name OSB Lead-Long-Term Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective cohort study that involves continued follow-up of the premarket cohort. The goal of this post-approval study is to assess longer-term performance of the BRYAN Cervical Disc in the treatment of patients with cervical degenerative disc disease. The primary consideration of longer-term performance will be overall success, a composite variable comprised of key safety and effectiveness parameters. The overall success rate for the BRYAN disc treatment will be compared to that of a concurrent fusion control group. Study success will be based on showing non-inferiority for the BRYAN device group overall success rate at ten years following surgery. The secondary objective of the study is to assess superiority, if non-inferiority can be established.
Study Population Description Study population is as per device indication. This device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The BRYAN device is implanted via an open anterior approach.
Sample Size Postoperative data will be collected at 5, 7, and 10 years on a minimum of 200 eligible patients (minimum of 100 patients each from control and BRYAN groups)
Data Collection The primary outcome variable, overall success, is defined below. A patient will be considered an overall success if all of the following conditions are met:
Follow-up Visits and Length of Follow-up Data will be collected at 60 months (5 years), 84 months (7 years), and 120 months (10 years) postoperative to determine the long-term safety and effectiveness of the device.
Final Study Results
Interim Safety Information As of the latest 12-month PAS interim report, 356 IDE subjects have been enrolled into PAS. Of them, 83% (160/193) Bryan Disc patients and 75% (119/159) control achieved success at 60-month follow-up.


OSB Lead-Long-Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/10/2009 11/10/2009 On Time
1 year report 05/12/2010 06/28/2010 Overdue/Received
18 month report 11/10/2010 11/10/2010 On Time
2 year report 06/10/2011 06/10/2011 On Time
3 year report 05/11/2012 05/09/2012 On Time
4 year report 05/11/2013 05/08/2013 On Time
5 year report 06/10/2014 06/10/2014 On Time
6 year report 05/11/2015 05/05/2015 On Time
Final Report 09/30/2016 09/16/2016 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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