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.
Subject enrollment milestones not met,
Follow-up rate below 80%
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
The study design is a multi-center, single arm, prospective cohort study.
Study Population Description
Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System,
a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR System is intended for patients who, due to their relatively youneger age or increased activity level may not be suitable for traditional total hip arthroplasty, due to an increased possibility of requiring future ipsilatcral hip joint revision.
The sample size is 350 patients.
Study endpoints include Harris Hip Score and device survival.
Followup Visits and Length of Followup
Patients will undergo clinical and radiographic examinations for the first five years of follow-up with
a final clinical and radiographic examination at 10 years. Subjects will receive annual questionnaire follow-up in years 6 through 9.