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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Extended f/u of premarket cohort


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General
Application Number P100003 / PAS001
Current Plan Approved 07/16/2014
Study Name OSB 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 This study includes investigational and control patients from the US IDE pivotal study (G050075), which was a multi-center, prospective,

randomized clinical study conducted to compare the safety and effectiveness of SECURE®-C Cervical Artificial Disc to control Anterior Cervical fusion surgery. The first subjects enrolled at each center were nonrandomized subjects receiving the SECURE®-C device.

Study Population Description Secure C patients and ACDF patients from IDE investigation

Sample Size The IDE study invovled 380/Subjects: 89 non-randomly assigned to

SECURE®-C, 151/Randomized to SECURE®-C, and 140/Randomized to

ACDF (control). Of these, 220/SECURE®-C patients (91.7%) and

114/ACDF patients (81.4%) yielded 24 month primary outcomes. As a result, the observed rate of missingness was (380 ¿ 220 ¿ 114) 380 =

12.1%. The IDE study was originally designed to randomize

280/Subjects with 80% study power in a 1:1/Ratio of treatment to control. For power calculation purposes, it was assumed that these

220 + 114/Subjects will constitute the beginning sample size for the

PAS1.

Data Collection Primary Endpoints

This study is required to evaluate overall success (protocol- specified primary endpoint) for each patient. The definition of success for an individual patient is based on meeting the following primary outcome measures of safety and effectiveness:

Pain Disability Improvement of at least 25% in the Neck Disability Index (NDI) at 5 years and 7 years compared with the score at baseline.

No device failures (at the index level) requiring revision, re-

operation, removal, or supplemental fixation.

Absence of major complications defined as major vessel injury, neurological damage, or nerve injury; and

For control fusion patients only, radiographic fusion, as defined by the presence of bridging trabecular bone, without evidence of pseudoarthrosis.

The FDA has also required the evaluation of overall success in which an individual patient is considered a success if the following primary (FDA-specified) outcomes measures of safety and effectiveness are met:

Pain Disability Improvement of at least 15 points in the Neck Disability Index (NDI) at 5 years and 7 years compared with the score at baseline

No secondary surgery at the index level, including revision,

removal, reoperation, and supplemental fixation

No potentially device-related adverse events

Maintenance or improvement in all components of neurologic status

No SECURE®-C intraoperative changes in treatment

Overall study success criteria are based on a comparison of individual patient success rates, such that the patient success rate for the SECURE®-C investigational group is no worse than that of the ACDF cervical fusion control group, using a delta of

10%.

Follow-up Visits and Length of Follow-up 7 years



Follow-up is annual (3- 7 year) (±4 months window).



OSB Lead-Extended f/u of premarket cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 03/29/2013 03/28/2013 On Time
one year report 10/28/2013 10/29/2013 Overdue/Received
18 month report 03/29/2014 03/28/2014 On Time
two year report 09/28/2014 09/26/2014 On Time
Final Report 10/31/2015 09/29/2015 On Time


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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