|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P070026 S004/ PAS001 |
Date Original Protocol Accepted |
04/02/2013
|
Date Current Protocol Accepted |
03/10/2015
|
Study Name |
Long-Term F/U of IDE COC36 patients
|
Device Name |
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Detailed Study Protocol Parameters |
Study Objectives |
Multi-center, cohort study
|
Study Population |
Patients will be enrolled from the IDE study
|
Sample Size |
It is anticipated that up to 80 subjects from the IDE study implanted with the 36 mm device will consent to participate.
|
Key Study Endpoints |
Device revision is the primary endpoint; secondary endpoints include Harris Hip Scores and radiographic findings.
|
Follow-up Visits and Length of Follow-up |
Patients will be followed for 10 post-operative years, These subjects will be evaluated at the time of consent (approximately 5 to 7 years post-op), again at a minimum 8 year follow-up interval, and finally at a minimum 10 year follow-up interval.
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
81 Subjects from among COC36 IDE study subjects.
|
Actual Number of Sites Enrolled |
57 sites were enrolled for the post-approval study.
|
Patient Follow-up Rate |
92% had follow-up with complete datasets at year 8 of follow-up. 81% had follow-up with complete datasets at year 10 of follow-up.
|
Final Safety Findings |
No significant differences were noted in the Harris Hip outcomes (total or any sub-score) as well as the acetabular and femoral radiographic summaries. Those who received all approved components (PMA cohort) had a slightly higher percent with any complication compared to subjects who received at least one non-PMA approved component (non-PMA cohort): 88.2% vs. 66.7% (p-value = 0.0237). The percent of subjects with systemic adverse events was slightly higher among the PMA cohort vs. the non-PMA cohort: 76.5% of Subjects vs. 56.7% of Subjects, respectively (p-value = 0.0825). The percentages of Subjects with Surgical Site adverse events was not significantly different for the PMA cohort vs. the non-PMA cohort: 29.4% vs. 26.7%, respectively (p-value = 1.000).
|
Final Effect Findings |
The 10-year device survivorship estimate is 96.6%, with a lower 95% confidence limit of 89.7% for those who received all approved components (PMA cohort). The 10-year device survivorship estimate is 96.7%, with a lower 95% confidence limit of 87.3% for those who received one or more non-PMA components.
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Study Strengths & Weaknesses |
Results provided further evidence of the clinical utility and safety of this device.
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Recommendations for Labeling Changes |
Post-approval study findings should be part of the device labeling.
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