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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-Coflex Actual Practice PAS


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General
Application Number P110008 / PAS002
Current Plan Approved 04/23/2013
Study Name OSB Lead-Coflex Actual Practice PAS
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Randomized clinical trial
Study Population Description The study population is comprised of patients with radiographic

confirmation of at least moderate degenerative spinal stenosis with constriction of the central spinal canal of one or two adjacent segments in the region L1 to L5.

Sample Size The sample size is 230 patients. There will be 115 patients in

each group. There will be 115 patients with decompression surgery and without Coflex, and 115 patients with decompression surgery and the Coflex.

Data Collection The primary endpoint is improvement of Oswestry Low Back

Pain Disability Index (ODI) after 24 months compared to control group.



Secondary endpoints encompass:



-Superior improvement of the Visual Analog Scale (VAS) for low back pain (on the 100

mm scale) within 24 months compared to control, group.



-Leg pain (Measurement via a 100 mm VAS)



-Zurich Claudication Questionnaire (ZCQ). This is a self rating questionnaire designed to assess symptom severity, physical functional status and patient satisfaction



-Assessment of significant migration of the implant or the complete expulsion

(significant is defined > 5 mm)



-Neurological status (assessment of the maintenance of the improvement after surgery

throughout the study duration)



- Walking distance test on a treadmill (assessment of improvement in walking distance)

Follow-up Visits and Length of Follow-up Patients will be followed for 2 years.

Patients will be evaluated pre-operatively, and at 3, 12 and 24

postoperative months.



OSB Lead-Coflex Actual Practice PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/17/2013 07/05/2013 Overdue/Received
one year report 12/01/2013 02/14/2014 Overdue/Received
18 month report 04/17/2014 06/13/2014 Overdue/Received
two year report 10/17/2014 11/28/2014 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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