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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 P070001 / PAS001
Current Plan Approved 08/12/2008
Study Name OSB Lead-Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective cohort to continue follow-up of the subjects who participated in (1) the IDE premarket study and (2) the continued access study.

Study Population Description The study population is as per device indication. The study includes IDE and CAS subjects. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
Sample Size 239 ProDiscTM -C (103 Randomized and 136 Continued Access) and 106 ACDF patients for a total of 345 patients
Data Collection A patient will be considered an overall success if all of the following conditions are met:

The patient's NDI score improves by at least 20% over preoperative baseline value;

The patient's neurologic parameters, i.e. motor sensory, and reflexes are maintained or improved as compared to preoperative baseline value

No removals, revisions, re-operations or additional fixation were required to modify any implant

No adverse events occur which are related to the treatment.



Follow-up Visits and Length of Follow-up Data will be collected at 36, 48, 60, 72 and 84 months postoperative
Final Study Results
Interim Safety Information So far, since the approval of the device (December 17, 2007), a total of 86 Adverse Events (AEs) from 40 ProDisc-C patients (39% of 103) and 98 AEs from 47 ACDF control patients (44% of 106) have been reported in the post-approval period follow-up of the IDE cohort as of November 23, 2009. During the same period, 188 AEs from 74 ProDisc-C patients (54% of 136) reported in the CAS cohort. For implant-related AEs, the CAS cohort had 2 cases (1 upper extremity pain and one index level surgery); and ACDF patients in the IDE cohort had 1 implant-related surgery.


OSB Lead-Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Long term study 6 month report 06/16/2008 06/18/2008 Overdue/Received
1 year report 12/16/2008 12/17/2008 Overdue/Received
18 month report 06/16/2009 06/18/2009 Overdue/Received
2 year report 12/16/2009 12/22/2009 Overdue/Received
3 year report 12/24/2010 12/23/2010 On Time
4 year report 12/16/2011 12/19/2011 Overdue/Received
5 year report 12/15/2012 12/17/2012 Overdue/Received
6 year report 12/15/2013 12/13/2013 On Time
7 year report 12/15/2014 12/15/2014 On Time
audit report 10/16/2015 10/15/2015 On Time
audit update report 01/16/2016 01/15/2016 On Time
final report 08/31/2016 08/31/2016 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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