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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
Site enrollment milestones not met,
Subject enrollment milestones not met
General Study Protocol Parameters
Study Design
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
Yes
Data Source
New Data Collection
Comparison Group
Objective Performance Criterion
Analysis Type
Analytical
Study Population
Transitional Adolescent B: 18-21 yrs,
Adult: >21
Detailed Study Protocol Parameters
Study Design Description
A prospective, non-controlled, non-randomized, multicenter study. This is a two-phased study consisting of a clinical
follow-up phase and a clinical outcomes phase.
Phase One (0-5 years): Diagnostic, demographic and operative information for each enrolled subject will be documented on case report forms developed for this study. Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
Phase Two (6 ? 10 years): A subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects on an annual basis.
Study Population Description
Males and females who are appropriate candidates for primary hip
replacement of any age, with non-inflammatory
degenerative joint disease.
Sample Size
A total of 250 Subjects will be enrolled in the investigation
? 100 subjects recruited from
IDE to PAS
? 150 new PAS subjects
US Centers. Five sites currently participating in the IDE study will continue subject follow-up and sites will be added to recruit the additional subjects needed for study sample size.
Data Collection
The primary study endpoint is device survival (90% survivorship of implanted hips at 10 years).
In the first 5 years, the overall subject success will be measured, which is a composite endpoint that incorporates clinical, radiographic, and survivorship criteria.
