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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-Post-Approval Study


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General
Study Status Progress Adequate
Application Number P140019 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Post-Approval 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 The study is designed to assess the long-term (out to 6 years post-op) performance of i-FACTOR compared to local autograft by continued follow-up of available subjects from the approved IDE study. NO new subjects will be enrolled. Subjects, radiologists and neuro evaluators will remain blinded. Subjects will be informed of their treatment after the last evaluation.
Study Population Description study group: allograft ring filled with i-FACTOR and stabilized with metallic anterior plate system

control group: allograft ring filled with local autograft bone and stabilized with metallic anterior plate system
Sample Size 218 subjects from the IDE study (106 investigational and 112 control) provided informed consent for long-term follow-up. The sponsor estimates attrition of 10 subjects per year due to lost-to-follow-up or withdrawal with a follow-up rate of at least 70% for each assessment period. Table 6 of the submission provides detailed power estimates for each primary endpoint, however each endpoint will have a minimum of 80% at each timepoint.
Data Collection primary endpoints:

radiographic assessment of fusion

Neck Disability Index (NDI) for function

neuro evaluations

rate and type of AEs

lack of secondary surgical interventions at the treated spinal level

secondary endpoints:

neck and arm/shoulder pain using VAS

SF36v2 quality of life

modified Odom¿s criteria for surgical success
Follow-up Visits and Length of Follow-up Each subject will be followed for total of 6 years post-op.


ODE Lead-Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 05/03/2016 04/29/2016 On Time
one year report 11/02/2016 11/02/2016 On Time
18 month report 05/03/2017 05/02/2017 On Time
two year report 11/02/2017 11/02/2017 On Time
three year report 11/02/2018    
four year report 11/02/2019    
five year report 11/01/2020    


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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