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 post-approval study is a prospective, multi-center, uncontrolled cohort study of subjects in whom the
device was implanted after FDA approval.
The purpose of the post-approval study is to evaluate the safety and effectiveness of the Trilogy AB Acetabular System through long-term follow-up of 10 years. 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
Study population is as per device indication and it includes: age from 21 to 80
years, body mass index less than 30, willing and able to provide informed consent. The device is indicated for either cemented or noncemented use in skeletally mature individuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
Endpoints not mentioned
Followup Visits and Length of Followup
During the first five years of the study clinical, radiographic, and subject self assessment information
will be collected for each subject. Data will be collected pre-operatively, immediately post-operatively, at three months and annually up to five years. An independent radiographic review will be conducted at five years. For the sixth through the tenth postoperative years, patients will be asked to return an outcomes questionnaire designed to determine the status of their hip replacement. In addition, you have agreed to record and report each adverse event regarding full details of the nature of the complication, treatment and outcome on the appropriate Case Report Form. You will send in Interim Study Status Reports to the FDA every six months for the first two years of the study and annually thereafter until a Final Study Report has been submitted. The results of this long-term data must be reflected in the product labeling (via supplement) when the post-approval study is completed.