|
General |
Study Status |
Completed |
Application Number / Requirement Number |
N980003 / PAS001 |
Date Original Protocol Accepted |
11/26/2003
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Date Current Protocol Accepted |
 
|
Study Name |
Encore Keramos PDP Study
|
Device Name |
KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM
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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
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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.
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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).
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