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 post-approval study is a prospective, uncontrolled multi-center study that is designed to evaluate the
long-term safety and effectiveness of the Duraloc Option Ceramic Hip. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13, 2010]. The description presented here is for the old study
Study Population Description
Study population as per device indication. This device is indicated for non-cemented use in primary
total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and post-traumatic arthritis.
A total of 250 patients 10 clinical centers
Key endpoints include device survival, Harris Hip Score, and radiographic assessment. During the final 5
years of patient follow-up, patients will only complete a mailed outcomes questionnaire that will inquire regarding device survival and patient satisfaction.
Followup Visits and Length of Followup
Each patient will be followed for 10 years. During the first 5 years of patient
follow-up, patients will undergo clinical and radiographic examination as well as complete an outcomes questionnaire.