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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-Superion New Enrollment Study


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General
Study Status Progress Inadequate
Application Number P140004 / PAS002
Date Current Protocol Accepted 02/21/2017
Study Name OSB Lead-Superion New Enrollment Study
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 Prospective, multi-center, randomized, controlled post-approval

(Conditions of Use) new enrollment study.



The first and primary objective is to evaluate longer term (5 year) Superion® device performance in the ¿actual conditions of use¿ population relative to surgical decompression. A composite clinical success (CCS) endpoint will be used to facilitate this comparison. The second objective of this study is to confirm that Superion®

performance is not clinically inferior in the post-approval study (PAS)

population compared to the pivotal IDE trial population. The Month

24 composite clinical success (CCS) endpoint used in the IDE trial will be employed to facilitate this comparison. Patients will be enrolled

at sites that were not involved in the IDE study.

The third objective is to test the hypothesis that Superion® is non- inferior to surgical decompression in terms of Month 24 composite clinical success (CCS).

Study Population Description Subjects suffering from moderate symptoms of neurogenic claudication secondary to a confirmed diagnosis of moderate LSS at one or two contiguous levels from L1 to L5 who meet all inclusion/exclusion criteria. Subjects will be either randomized to the Vertiflex or ACDF.
Sample Size 358 patients (152 per group plus 18% to account for LTF)



Simulations were conducted to determine power and type 1 error. A sample size of N=152 per group was selected. When determining type 1 error, Month 60 CCS was assumed to be 0.125 higher for decompression compared to Superion®. With N=152 evaluable patients per group, statistical power and type 1 error for testing non- inferiority (non-inferiority margin = -0.125) were estimated to be

80% and 0.043 for the Month 60 PAS CCS.

Data Collection Primary effectiveness end point is a composite of safety and effectiveness.

Clinically significant improvement in outcomes compared to baseline, as determined by meeting the following for at least two of three domains of the Zurich Claudication Questionnaire (ZCQ):

- Improvement in physical function by ≥ 0.5 points

- Improvement in symptom severity by ≥ 0.5 points

- ¿Satisfied¿ or ¿somewhat satisfied¿ as defined by a score of < 2.5 points on the

patient satisfaction domain - No re-operations, revisions, removals, or supplemental fixation at the index level(s)

- No ≥2 injections or series of epidural steroid injections for the treated level(s)*, or nerve block procedures performed to treat spinal stenosis at the index level(s); or a single epidural steroid injection within 12 months of the 5-year endpoint.

* A series of injections is considered 2-3 injections performed between 24-hour and one week intervals designed to treat a single pain event. Secondary injections performed due to patient demand or recurrence of symptoms following the initial injection are considered separate injections and would constitute a study failure.

Secondary endpoints will be evaluated to meet Objectives 2 and 3. Secondary Endpoints:

Zurich Claudication Questionnaire (ZCQ); neurological status as determined by physical exam; radiographic information; maintenance of distraction; incidence of epidural injections regardless of the cause and spinal level injected; incidence of analgesic narcotics usage; reoperations, revisions, removals or supplemental fixation at the index levels; SF-12 Short Form Health Survey, Version 2; VertiFlex® Patient Satisfaction Survey; Visual Analog Scale (VAS); Oswestry Disability Index (ODI), return to work and to activities of daily living and rehabilitation utilization.



Safety Endpoints:

1. Documentation of Adverse Events and SAEs and implant and surgery related complications (e.g., breaking of implants). Specific AEs will be summarized according to incidence (per patient) and counts of AE over time.

2. Assessment of revisions and additional stabilizations.

3. Assessment of epidurals.

4. Assessment of analgesic narcotics usage.





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

The visits are as follows: baseline, treatment, discharge, 6- weeks, 12-months and annually thereafter



OSB Lead-Superion New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 05/19/2016 05/20/2016 Overdue/Received
two year report 05/19/2017 05/19/2017 On Time
three year report 05/19/2018    
four year report 05/19/2019    
five year report 05/18/2020    


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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