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.
The study population is comprised of patients who received the device during the IDE or
controls that underwent ACDF during the IDE.
The sample size is comprised of 142 PCM cervical disc patients and 110 controls that underwent
The primary endpoint will be individual subject success at the 7 year visit. -Success- is
Improvement of at least 20% on the Neck Disability Index (NDI) at 7 years compared to baseline; No device failures (at the index level) requiring revision, re-operation, removal, or supplemental fixation; No major complications such as vascular or neurological injury; Radiographic success
Secondary endpoints include neurological assessment, Neck and Arm Pain Visual Analog Scale, and Short-Form-36 Health Survey Questionnaire.
Followup Visits and Length of Followup
7 years. Patients will undergo follow-up assessments at 5, 6, and 7 post-operative years..