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 cohort. This 10-year postapproval study would be conducted to
evaluate the longer-term safety and effectiveness of the Stelkast Surpass Acetabular System. The recruitment of patients, physicians and health care facilities in the post-approval study for this device has been inadequate.Due to enrollment problems. in a letter dated, July 14, 2009, FDA requested a revised post-approval study. The new protocol is not approved yet [Aug 13,2010]. The description presented here is for the old study
Study Population Description
Patients who have been implanted with Stelkast Surpass Acetabular System is a ceramic/ceramic acetabular bearing
couple for a total hip prosthesis.
300 subjects enrolled
Study endpoints include device revision and Harris Hip Score during the first five years of
Followup Visits and Length of Followup
Patients will undergo clinical and radiographic examination for their first five ears of follow-up. During
their last 5 years of follow-up patients will receive questionnaires regarding the status of their total hip replacements.