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 Prospective Post-Approval Study is a single-arm observational study
Approximately 100 qualified subjects, at up to 10 centers, previously enrolled in the original prospective
post-approval study will be longitudinally followed after their primary total hip replacement surgery.
Clinical data (hip function), radiographic evaluations, an outcomes questionnaire, and subject self-assessment information was/will be
collected for each subject. Key endpoints include device survival, Harris Hip Score, and radiographic assessment.
Followup Visits and Length of Followup
The length of follow-up for this study is 5 years. A quality of life survey
(SF-12) was/will be completed by the subject for all post-operative visits up to the 5-year follow-up interval. The Subject Outcomes Questionnaire was/will be completed by the subject at the one year follow-up interval and annually after that up to the 5-year follow-up interval. The (modified Harris) Hip Function Evaluation was/will be used to clinically assess each subject pre-operatively, and at 6 weeks, 6 months, and annually for five years postoperatively. High quality anteroposterior pelvis (AP-pelvis) and lateral radiographs of the operative hip were/will be obtained during the same postoperative follow-up intervals as for the clinical evaluations.