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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-Extended f/u of premarket cohort


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General
Study Status Completed
Application Number P100003 / PAS001
Date Current Protocol Accepted 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).

Interim or Final Data Summary
Actual Number of Patients Enrolled Out of 380 subjects enrolled in IDE, a total of 334 subjects: 220 SECURE-C patients (91.7%) and 114 ACDF patients (81.4%), were available at the 24-month timepoint for enrollment into the Extended Follow-Up Study.
Actual Number of Sites Enrolled Out of 18 sites from the initial IDE study, the current Extended Follow-Up Study involved a total of 16 sites.
Patient Follow-up Rate With a total of 288 subjects followed up until 84 months, the overall follow up rate at the final timepoint was 75.8%, per the initial number of IDE patients (380) and the 7-year follow-up visits: 186 Secure-c (61 nonrandomized, 125 randomized) patients and 102 ACDF patients. However, the follow-up rate at



interim visits was much lower, with the Actual in window % follow-up rates reaching only 20-25% for the most of Secure-c visits.

Final Safety Findings No evidence raising serious concerns on Secure-c safety was found. However, a continuing long-term follow-up through the on-going 10-year ESS study is considered imperative for further assessment of this device and the relatively new TDR technology in general. MDRs reporting posterior expulsion/migration suggested a particular need for the further assessment and labeling update as well

as for other possible regulatory actions (if needed) to address this particular AE that was not anticipated upon pre-market approval of the Secure-c disc. A higher rate for cardiovascular adverse events (mostly, in mild category) was observed among Secure-c versus ACDF patients. In addition, clinically-relevant Heterotopic Ossification (Grade III-IV) was found in every fifth Secure-c patient at the 60-months and in every fourth Secure-c patient at the 84 month. Based on the corresponding ROMs, the premise of maintained motion is not fulfilled after 5 years in at least 20-25% of Secure-c patients.

Final Effect Findings Overall success outcomes including the FDA-defined criteria clearly demonstrated non-inferiority of Secure-c compared to ACDF. Superiority of the investigational group to the control was established for overall success at 24, 60 and 84 months. Superiority in Patient Satisfaction in the Secure-c group compared to the control group was achieved at 24 and 84 months. The changes in NDI score from baseline were not statistically different between Secure-c and control groups, but showed greater improvement for the SECURE-C group at 84 months. The change in global ROM was statistically greater for SECURE-C than ACDF at 24, 36, and 48 months, but was not different at 60, 72, and 84 months. Mean disc height was greater for the Secure-c group at all postoperative time points. However, the lack of correlation between ROMs and overall success, NDI, and VAS pain scores suggested the need for further scrutiny over the Secure-c ability to benefit clinical outcomes via the motion preservation.
Study Strengths & Weaknesses This Extended Follow-Up study was capable of demonstrating non-inferior, and in some instances superior, performance of the investigational Secure-c device compared to ACDF as control. However, a further comparative analysis of the Secure-c disc vs. cervical fusion as the current standard of care is still warranted, particularly with regard to the premise of preserved motion and subsequent clinical benefits that are anticipated as a result of the TDR procedure.
Recommendations for Labeling Changes The current labeling is recommended to be updated based on long-term device performance (7-years).


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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