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
The study design is single-arm, prospective cohort. There are no formal study hypotheses. 10 year
post-marketing prospective hip study enrolling a minimum of 257 primary total hip replacements of whom a minimum of 160 will be followed out to 5 years and a minimum of 100 patients will be followed for 10 years. The first phase of the investigation will gather clinical, radiographic, and survivorship data for 5 years following implantation. The second phase, years 6 through 10, will utilize mailings to gather survivorship information. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13, 2010]. The description presented here is for the old study
Study Population Description
Patients who underwent total hip arthroplasty using a C2 a-Taper Acetabular System ceramic on ceramic
hip articulating system.
Sample Size
The sample size is 257 patients.
Data Collection
Study endpoints include device revision and Harris Hip Score during the first five years of
follow-up.
Followup Visits and Length of Followup
Patients will undergo clinical and radiographic examination for their first five years of follow-up. During
their last 5 years of follow-up patients will receive annual questionnaires regarding the status of their total hip replacements.
