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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective cohort to continue follow-up of the subjects who participated in (1)
the IDE premarket study and (2) the continued access study.
Study Population Description
The study population is as per device indication. The study includes IDE and CAS subjects.
This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
Sample Size
239 ProDiscTM -C (103 Randomized and 136 Continued Access) and 106 ACDF patients for a
total of 345 patients
Data Collection
A patient will be considered an overall success if all of the following conditions are
met:
The patient's NDI score improves by at least 20% over preoperative baseline value;
The patient's neurologic parameters, i.e. motor sensory, and reflexes are maintained or improved as compared to preoperative baseline value
No removals, revisions, re-operations or additional fixation were required to modify any implant
No adverse events occur which are related to the treatment.
Followup Visits and Length of Followup
Data will be collected at 36, 48, 60, 72 and 84 months postoperative
