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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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Coflex Actual Practice PAS USA


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General
Study Status Progress Inadequate
Application Number P110008 / PAS003
Date Current Protocol Accepted 06/21/2018
Study Name Coflex Actual Practice PAS USA
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 Study Objective: To conduct 2 and 5 year comparative evaluation of clinical outcomes in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the Coflex® Interlaminar Technology.
Study Design: multicenter, non-randomized but concurrently enrolled, propensity score controlled clinical study (new enrollment, patient-blinded)
Study Population Description Patients suffering from a confirmed diagnosis of moderate spinal stenosis with concomitant low back pain at one or two contiguous levels from L1-L5 that require surgical decompression and who meet all of the inclusion/exclusion criteria.



Group A: decompression surgery without any further stabilization by an implant (control group)



Group B: decompression surgery with additional stabilization with the coflex® Interlaminar Technology (treatment group).

Sample Size The total enrolled will be 186 coflex® patients and 220 decompression control patients at up to 20 investigational sites (up to 10 coflex and 10 control sites). This sample size is based on 150 per group (300 total) plus 15% to account for lost to follow-up in both groups, plus 20% in the control group and 5% in the study device group to account for trimming of control patients and possible trimming of study device patients during the propensity score design.
Data Collection Primary endpoint is CCS:



At least 15 point improvement relative to pretreatment in the Oswestry Disability Index (ODI).

No reoperations, revisions, removals, or supplemental fixation at index level(s).

No greater than or equal to 2 injections or series of injections for the treated level, or nerve block procedures performed to treat spinal stenosis for the index level(s); or a single injection within 12 months of the 5 year endpoint.

As an exploratory analysis, primary hypothesis will be tested using:

At least 15 point improvement relative to pretreatment in ODI.

No reoperations, revisions, removals, or supplemental fixation at index level(s).

No epidural injections or nerve block at any level at any time.



Secondary Endpoints:

ODI change compared to baseline at 24 and 60 months.

Change in Visual Analog Scale (VAS) for low back pain after 24 and 60 months compared to baseline.

Change in leg pain using VAS after 24 and 60 months compared to baseline.

Change in worst leg pain using VAS after 24 and 60 months compared to baseline.

Change of Zurich Claudication Questionnaire (ZCQ) after 24 and 60 months compared to baseline.

Maintenance or improvement in EQ-5D compared to baseline.

Change from baseline to Month 24 and Month 60 in maximum walking time from treadmill test.

Neurological status. Radiography Endpoints:

1. Migration of the implant or the complete expulsion

2. Spinous process fracture

3. Maintenance of foraminal height

4. Adjacent level disease





Follow-up Visits and Length of Follow-up 60-months





Coflex Actual Practice PAS USA Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/05/2016 02/08/2016 Overdue/Received
one year report 09/05/2016 09/02/2016 On Time
two year report 09/05/2017 09/26/2017 Overdue/Received
three year report 09/05/2018 09/24/2018 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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