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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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ODE Lead-10 Year Extended f/u of IDE Subjects


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General
Study Status Progress Adequate
Application Number P090029 S003/ PAS001
Study Name ODE Lead-10 Year Extended f/u of IDE Subjects
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 10 Year Extended Follow-up of IDE Subjects Treated with the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels is a 10-year post-approval study (PAS) to evaluate the longer term safety and effectiveness of the PRESTIGE LP™ Cervical Disc.

This study has a multi-center, prospective, randomized, controlled design. The bi-level ACD-LP treatment will be compared to the control treatment, a bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS® Cervical Plate System.

Study Population Description Patients who have been diagnosed with symptomatic cervical degenerative disc disease at two adjacent levels (from C3-C7) according to the specified inclusion/exclusion criteria as stated in the protocol (Version G).
Sample Size 397 subjects treated in the pivotal investigational device exemption (IDE) study (209 2-level PRESTIGE LP™ subjects and 188 2-level ACDF control subjects)
Data Collection The primary endpoint was (individual subject) overall success at 24 months, a composite variable which included safety and effectiveness considerations, and was defined as follows:

1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;

2. Maintenance or improvement in neurological status;

3. No serious adverse event classified as implant associated or implant/surgical procedure associated (as determined by an independent clinical adjudication committee); and

4. No additional surgical procedure classified as a “failure.

Secondary endpoints, measured in both treatment groups, included neck pain, arm pain, quality of life (SF-36 Physical Component Score [PCS] and Mental Component Score [MCS]), gait assessment (Nurick’s classification), subject satisfaction, subject perceived effect, physician perception of results, radiographic success (defined differently in the two treatment groups), range of motion, Functional Spinal Unit (FSU) height, implant condition, heterotopic ossification, and return to work.

Follow-up Visits and Length of Follow-up 120 months (+/-3 months)


ODE Lead-10 Year Extended f/u of IDE Subjects Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/05/2017 12/20/2016 On Time
one year report 07/07/2017 07/06/2017 On Time
18 month report 01/05/2018    
two year report 07/07/2018    
three year report 07/07/2019    
four year report 07/06/2020    
five year report 07/06/2021    


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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