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.
This is a prospective, multi-center, open label clinical study. Up to ten (10) centers around
the United States will participate in this study. 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
The study population is comprised of patients implanted in the United States and potentially outside
the United States in Greece and/or France. Sample size and power calculations are not provided in the protocol. Patients who receive the Novation Ceramic Articulation System for Non-inflammatory Degenerative Joint Disease
prospective and retrospective cohort, active surveillance, up to 10 clinical sites in prospective and retrospective
cohort, and 7 sites in active surveillance
The first phase of the study extending through 5 years of patient follow-up, will consist
of clinical examination, including the determination of a Harris Hip Score, radiographic examination and the collection of subject self-assessment data. These data will be obtained pre-operatively, immediately post-operatively, at three months, and annually up to five years. An independent radiographic review will be conducted at five years
In the second phase, during postoperative years 6-10, an outcomes questionnaire will be mailed to subjects to determine the status of their hip replacement. No clinical and/or radiographic examinations are proposed for this time period.
The study endpoints are as follows:
Efficacy Endpoints 1) Survivorship of the Novation Ceramic AHS system at 2, 5, and 10 years. 2) Patient success defined as: - Absence of revision - Harris Hip Score greater than or equal to 70 - No complete radiolucencies
The following endpoints will also be evaluated at the 2-year follow-up: - Harris Hip Score - Radiographic assessment - SF-12
Safety endpoints will encompass complication rates, including incidence, severity and the relationship to the device.
Followup Visits and Length of Followup
The length of patient follow-up is 10 years. Follow-up visits will occur pre-operatively, immediately post-operatively,
at six weeks, six months, and annually up to five years. Study subjects will receive annual questionnaires from postoperative years 6 through 10.