In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Follow-up rate below 80%,
More than 10% of the primary endpoint data missing
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
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
The IDE study invovled 380/Subjects: 89 non-randomly assigned to
SECURE®-C, 151/Randomized to SECURE®-C, and 140/Randomized to
(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
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
Followup Visits and Length of Followup
Follow-up is annual (3- 7 year) (±4 months window).