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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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Encore Keramos PDP Study


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General
Study Status Completed
Application Number /
Requirement Number		 N980003 / PAS001
Date Original Protocol Accepted 11/26/2003
Date Current Protocol Accepted  
Study Name Encore Keramos PDP Study
Device Name KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Interim or Final Data Summary
Actual Number of Patients Enrolled 873 subjects with 975 implants
Actual Number of Sites Enrolled There were 3 clinical sites in the study.
Patient Follow-up Rate For implants, 79% for at least one follow-up visit
For subjects, 85.7% with at least one follow-up
Final Effect Findings Keramos Control
Are You Satisfied with How Your
Implant Is Functioning? Yes (n) No (n) Yes (n) No (n)
Year 13 59 6 56 1
Year 14 60 5 52 1
Year 15 18 1 19 2
Study Strengths & Weaknesses A strength of the study is its substantial sample size, with 873 study subjects and 975 total hip implants. A weakness of the study is the absence of clinical and radiographic examination in the final 5 years of follow-up.
Recommendations for Labeling Changes The longer term revision rates were comparable between the Keramos and Control implants. There were a total of 64 revisions reported in the postcard follow-up with an average of 9.8 years after implantation. The proportion of intact implants in the Keramos subject at the end of the 2013 postcard follow-up was 92.3% vs. 89.8% in the Control subjects. In the time-to-event analysis, the survival curves for freedom from revision for the Study implants and the Control implants were completely overlapping. The unadjusted hazard ratio for revision comparing the Study implants to the Control implants was 0.99. After adjusting for age, gender, BMI and primary diagnosis, the hazard ratio was 0.88 favoring the Study implants (not statistically significant). There was also no subgroup difference in revision rates. Significant predictors for revisions include BMI (the higher the BMI, the higher the risk of revision) and primary diagnosis at baseline (OA diagnosis was associated with a lower risk of revision compared to other diagnosis).


Encore Keramos PDP Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Annual Report - Final 01/14/2014 01/14/2014 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

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