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.
multi-center, open-label clinical study. Prospective and retrospective enrollment is allowed.
Study Population Description
Patients who are scheduled to undergo total hip arthroplasty with a hard bearing prosthesis should be
screened for enrollment in this post approval study. Likewise, patients who previously underwent total hip arthroplasty with the NOVATION Ceramic AHS with one of the femoral stems allowed in this protocol may be screened for enrollment. Screening of patients who previously received the device should include any patients who have subsequently undergone revision, as the events leading to the revision will provide valuable information about the safety and effectiveness of the device. Patients who meet all inclusion criteria and no exclusion criteria will be asked to participate in the study.
Up to ten (10) centers will participate in this study. 125 hips.
The objective of this study is to gather supplementary long-term information regarding the safety and efficacy
of the NOVATION Ceramic AHS.
Efficacy Endpoints - Survivorship of the NOVATION Ceramic AHS at 2, 5, and 10 years follow-up
- Patient success (defined by inclusion of all the criteria below) will be provided annually out to 5 years follow-up: o Absence of revision o Total Harris Hip Score ≥ 80 o No complete radiolucencies as determined by radiographic evaluation of 3 views: acetabular AP view (3 zones1), femoral stem AP view (7 Gruen2 zones), and femoral stem lateral view (7 Gruen zones). Complete radiolucency is defined to be present if there is any radiolucency present in all the zones comprising that view. Absence of complete radiolucency is defined to be present if none of these three views have complete radiolucency.
A non-successful patient outcome will be characterized as one or more of the following: o Revision of any device component of the NOVATION Ceramic AHS; o Total Harris Hip Score less than 80; or o Complete radiolucencies as defined above.
● Harris Hip Score, SF-12, and radiographic findings will be evaluated, as per the Study Procedures section, and reported annually until all patients have reached 5 years of follow-up.
Safety Endpoint - Complication rates, including incidence, severity, and relation to device.
Followup Visits and Length of Followup
Visit Windows Subjects shall have visits completed within the following allowable windows: Visit Visit Window Preop (baseline) Within