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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P050016 / PAS002 |
| Date Original Protocol Accepted |
07/03/2007
|
| Date Current Protocol Accepted |
11/04/2008
|
| Study Name |
New Enrollment
|
| Device Name |
CORMET HIP RESURFACING SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a multi-center, prospective cohort study. The first null hypothesis of the study is that the 24 month cumulative revision rate is more than 0.126. The second null hypothesis is that the 24 month composite clinical success rate is less than 0.81.
|
| Study Population |
Study population is as per device indication.
|
| Sample Size |
The sample size is 160 procedures.
|
| Key Study Endpoints |
For both primary efficacy endpoints (freedom from revision and composite clinical success), the primary objective will be met by way of estimation using 95% exact binomial confidence intervals. Device survival will be illustrated by life tables and the plotting of a Kaplan-Meier curve.
|
| Follow-up Visits and Length of Follow-up |
Patients will be evaluated preoperatively, and at 6 weeks, 6 months, 12 months and 24 months postoperatively. The length of patient follow-up is two years.
|
| Interim or Final Data Summary |
| Interim Results |
Good-excellent Harris Hip Scores were obtained by 95.2% of study participants at 6 post-opertaive months and 97.4% at 12 post-operative months. Two cases of femoral neck fracture were reported.
|
| Actual Number of Patients Enrolled |
A total of 147 patients and 160 hips were enrolled in the study.
|
| Actual Number of Sites Enrolled |
A total of six study sites enrolled patients into the study.
|
| Patient Follow-up Rate |
Follow-up in the study was 81.8% at 24+months.
|
| Final Safety Findings |
The percentage of study subjects who achieved Composite Clinical Success (CCS), 92.5%, in the unilateral analysis groups for the Post-Approval (PAS) study was higher than that for the Pre-Market study,
90.6%.
|
| Final Effect Findings |
A pronounced increased in Harris Hip Scores, a measure of device effectiveness, was observed post- operatively. The mean Harris Hip Score pre-operatively was 53.9 for unilateral patients and 60.2 for bilateral patients. The mean Harris Hip Score at 24+ post-operative months was 96.1 for unilateral patients and 93.5 for bilateral patients.
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| Study Strengths & Weaknesses |
A strength of the study was that it was appropriately powered for the study endpoints. An additional strength of the study was the fact that a broad cross-section of clinical sites participated in the study. A study weakness was the absence of a concurrent control group.
|
| Recommendations for Labeling Changes |
Labeling changes are recommended. The sponsor should be instructed to submit a labeling change supplement for the post-approval study that encompasses the findings regarding the post-approval study that are delineated above.
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