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 study design is a prospective, multi-center cohort study
Study Population Description
The study population is comprised of patients implanted with the Pinnacle CoMplete Acetabular System.
The sample size is 250 patients.
The primary endpoint is device survivorship. The secondary objective is to evaluate five year cobalt
and chromium median metal ion levels along with renal function indicators to include BUN levels and creatinine levels.
Followup Visits and Length of Followup
Patients will receive clinical examination postoperatively at 4 weeks, 3 months, and 1, 2,
3,4, 5, 8, and 10 years. Patients will undergo radiographic examination at 4 weeks, and 1, 2, 3, 4, 5, 8, and 10 postoperative years. For patients in the metal ion study, metal ion testing and renal function testing will occur preoperatively and postoperatively at 1, 2, 5, 8, and 10 postoperative years.