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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
The primary objective of the study is to evaluate the overall long-term success rate (see
primary end-points for the definitions) of the investigational device as compared to the control in subjects enrolled in the pivotal IDE study of the Mobi-C (1-levels) device (IDE Number G050212).
Design-Prospective Cohort (extended follow-up of IDE patients)
Study Population Description
All eligible Mobi-C patients treated at one level. All eligible fusion patients treated at one
level under the LDR-001 Pivotal Study (IDE G050212)
245 subjects are still enrolled in the study (at the time of the Primary Endpoint
24 month analysis) and eligible for long term follow-up in the post-approval study. This includes 155 randomized investigational subjects, 75 randomized control subjects, and 15 non-randomized training case (investigational) subjects.
The primary endpoint of the study is individual patient success which is defined using the
two measures of composite study success. 1. When assessing the composite endpoint, all components need to be successful for the endpoint to be considered a success. However, only 1 component needs to be a failure for the endpoint to be considered a failure.
2. Note: the data will be also analyzed for the primary
outcome based on the 2nd definition for the success. See approval condition #1 and page 18 for the current submission.