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 is a multi-center, non-randomized, cohort study, which includes the extended follow-up of the
Study Population Description
Study population is as per device indication.
The sample size is up to 448 patients.
Data collection includes patient demographic data and medical history. A functional evaluation will be performed
including a Harris Hip Score. Radiographic examination will encompass anteroposterior (AP) and lateral plain film studies.
Followup Visits and Length of Followup
Patients will receive clinical and radiographic examination at 3, 4, 5, 8 and 10 postoperative
years. In addition, patients will receive brief questionnaires at 6, 7, and 9 postoperative years. For both primary efficacy endpoints (freedom from revision and composite clinical success) , the primary objective will be met by way of estimation using 95% exact binomial confidence intervals. Device survival will be illustrated by life tables and the plotting of a Kaplan-Meier curve.