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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Ceramax PAS


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General
Study Status Completed
Application Number P070026 / PAS001
Date Current Protocol Accepted 03/18/2015
Study Name Ceramax PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is prospective.
Study Population Description Males and females who are appropriate candidates for primary hip
replacement with non-inflammatory degenerative joint disease.
Sample Size A total of 250 Subjects will be enrolled in the investigation
100 subjects recruited from IDE to PAS
150 new PAS subjects
There will be 5 sites enrolling IDE patients and 10 sites enrolling newly enrolled patients.
Data Collection The main study endpoint is device revision. Secondary endpoints include Harris Hip Score and radiographic findings.
Follow-up Visits and Length of Follow-up Follow-up to 10 years.
Interim or Final Data Summary
Actual Number of Patients Enrolled 179 subjects/181 hips (including 2 bilateral).
Actual Number of Sites Enrolled 13 sites with IRB approvals including 11 activated/ participating sites.
Patient Follow-up Rate Throughout the study, follow-up rates decreased from 64% at 6 weeks in New PAS subjects and 92% at 7 years in IDE Rollover subjects to levels below 50% at the final study time points in both groups. Considering the decision on close-out of 28mm Ceramax Hip System study, no new follow-up measures were implemented; however, the loss-to-follow-up was considered in the assessment of long-term device survival and overall study findings.
Final Safety Findings A total of 8 cumulative revisions for any component and any reason were reported throughout the study among IDE Rollover and New PAS subjects. Due to no change in the number of revisions since Year 3, device survival estimates in the 28mm Ceramax Hip System PAS remained at the level of 96.7% (95% CI: 93.4, 98.3) from Year 3 to Year 10. However, the numbers of Hips Remaining at the same time points decreased from 199 to 51, respectively. To enhance the reliability of safety assessment in this PAS, the 10-year survival assessment was complemented by evaluating Ceramax device performance captured within the National Joint Registry of England, Whales, Northern Ireland and the Isle of Man (NJR). The NJR registry-based 10-year cumulative revision rate for 28mm Ceramax bearing was estimated as 4.08% (95% CI: 3.54, 4.69) in 5,724 patients.
Final Effect Findings Harris Hip Success at 5-years was achieved in 96.2% (76/79) of subjects in the entire 28mm Ceramax hip dataset, with the same number of subjects (96.2%) having total Harris Hip Score >80. However, there were a total of 43 subjects with <80 scores and only 87.7% (64/73) satisfied the criteria for Overall Composite Clinical Success. With the low long-term follow-up affecting subgroup analyses, the Overall Composite Clinical Success rates were much lower in the New PAS subjects (77.8% and 50.0% in IDE Rollover and New PAS subjects, respectively). The 10-year estimates for total Harris Hip Score, Pain Score, and Function and Activity Score were reported as 96.0%, 42.5%, and 44.3%, respectively.
Study Strengths & Weaknesses The 28mm Ceramax Hip System PAS provided safety and effectiveness data for ceramic hips with smaller size heads as well as identified potential treatment modifying effects (e.g., due to surgical approach). However, due to the low long-term follow-up rates, there was a need for complementary evidence from orthopedic registries to substantiate the assessment of long-term device survival. The NJR 28mm cumulative revision rates should be interpreted with caution because the cases within NJR are from non-US population which includes mostly Non-PMA approved systems (i.e., hip systems with different stems and acetabular cups compared to those approved for use with the Ceramax system in the US). Less than 1% of data points in NJR are representative of the US approved construct. Additionally, evidence from published literature was used to complement the assessment of other safety aspects of ceramic hips such as ceramic fracture and its possible consequences (e.g., third body wear) in subsequent total hip replacements.
Recommendations for Labeling Changes Post-approval study findings should be part of the device labeling. Additional clarifications on risks and outcomes as identified in the literature review should also be added to the labeling. Labeling update may need to include some results on possible modifying effects as well as warnings regarding the low long-term follow-up and lack of radiographic assessment affecting the assessment of acoustic phenomena (joint crepitation) and other safety and effectiveness outcomes.


Ceramax PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/23/2011 06/23/2011 On Time
18 month report 07/22/2012 07/24/2012 Overdue/Received
two year report 12/22/2012 12/26/2012 Overdue/Received
three year report 12/22/2013 12/20/2013 On Time
four year report 12/22/2014 12/17/2014 On Time
five year report 12/22/2015 12/21/2015 On Time
six year report 12/21/2016 12/14/2016 On Time
seven year report 12/21/2017 12/20/2017 On Time
eight year report 12/21/2018 07/17/2018 On Time
status report 01/17/2019 01/17/2019 On Time
final report 07/23/2020 06/30/2020 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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