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.
It is anticipated that up to 80 subjects from the IDE study implanted with the
36 mm device will consent to participate, and 90 more will be newly enrolled. These subjects will be seen for a clinic visit at the time of consent (approximately 5 to 7 years post-op), again at a minimum 8 year follow-up interval, and finally at a minimum 10 year follow-up interval. It is anticipated that a minimum of 58 unrevised subjects in this PAS will have a minimum 10 year post-op clinic evaluation.
A total of 170 subjects from up to five (5) sites will participate. These sites
participated in the IDE study and will continue subject follow-up.
Device survivorship will be estimated with a Kaplan-Meier survivorship analysis at 10 years post-operatively.
1. Device survivorship will also be estimated at each year post- operatively.
2. Harris Hip scores, Subject-hip outcomes, radiographic evaluation, and type and frequency of AEs will also be estimated at each year post- operatively.
Followup Visits and Length of Followup
Subjects will be seen for a clinic visit at the time of consent (approximately
to 7 years post-op), again at a minimum 8 year follow-up interval, and finally at a minimum 10 year follow-up interval. If applicable, such as for survivorship analysis purposes, IDE study data will be utilized by the Sponsor for PAS purposes.