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.
Approximately 80 subjects at multiple clinical sites who have previously received a DURALOC Option implant
will be longitudinally followed after their primary total hip replacement surgery.
DePuy will provide annual reports from the DOTS registry patients and provide these reports to
the FDA in annual progress reports. DePuy will provide the following information: - Femoral Stem types - The years in which the surgeries were performed - Patient demographic summaries (age, gender, diagnosis, height, weight, BMI) - Patient listing of reasons for revisions - Revision rate - Death rate - Kaplan-Meier survival estimates - Harris Hip Score over time - Adverse Events - Radiographic results
Followup Visits and Length of Followup
The length of follow-up for this study is 5 years.