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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-Extended f/u of Premarket Cohort


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General
Study Status Progress Adequate
Application Number P100006 / PAS001
Date Current Protocol Accepted 03/18/2016
Study Name ODE Lead-Extended f/u of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this study is to evaluate the long-term effectiveness and safety of AUGMENT® Bone Graft vs. autoglogous bone graft. This study is a continued follow-up of the pre-market cohort.
Study Population Description The effectiveness and safety profile for AUGMENT® Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.
Sample Size 150 projected (2:1, treatment:control) of the 414 potential prior subjects
Data Collection The primary effectiveness endpoints will consist of the following:

- Demonstration of bridging bone via CT

- Patient Function as determined by Pain on Weight Bearing (via VAS), AOFAS Score and Foot Function Index (FFI)

The primary safety endpoints will consist of the following:

- Presence of all adverse events (i.e., description, frequency, incidence, time to onset of first event, severity, duration, treatments administered, etc.)

- Presence of serious unanticipated adverse device effects (UADE)

- rhPDGF-BB antibody status

- At evaluation, subjects will be interviewed regarding significant medical conditions, including incidence of cancer

- Presence of clinically important events as defined below:

o Musculoskeletal and connective tissue disorders (severe pain, swelling and/or arthralgia in the treated foot/ankle joint(s));

o Additional surgery of the original treated joint due to non-union.

o Neoplasms benign, malignant and unspecified (including cysts and polyps) (all lower level terms associated with neoplasms)

o Complications related to bone graft harvest site
Follow-up Visits and Length of Follow-up The patients will have one study visit at >5 years post-op.

Frequency of Follow-up Assessments

The patients will have one study visit at >5 years post-op.


ODE Lead-Extended f/u of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 08/31/2016 08/31/2016 On Time
18 month report 03/01/2017 03/01/2017 On Time
two year report 08/31/2017 08/30/2017 On Time
three year report 08/31/2018    


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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