|
|
| 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.
|
| Study Strengths & Weaknesses |
Results provided further evidence of the clinical utility and safety of this device.
|
| Recommendations for Labeling Changes |
Post-approval study findings should be part of the device labeling.
|
