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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P030022 / PAS001 |
| Date Original Protocol Accepted |
12/17/2004
|
| Date Current Protocol Accepted |
12/17/2004
|
| Study Name |
Reflection Long Term
|
| Device Name |
REFLECTION CERAMIC ACETABULAR SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center prospective follow-up study that continues to follow through their 10th post-implantation year several cohorts of subjects enrolled in the original IDE study.
|
| Study Population |
This device is indicated for use in patients requiring primary tectal hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avaseular necrosis, or traumatic arthritis. The study population consist of four cohorts: (1) Randomized Non-inflammatory Arthritis (RNIA) cohort; (2) the Randomized Inflammatory Arthritis (RIA) cohort; (3) the Revision Hip (RR) cohort , and (4) the Continued Access Cohort (CAC) cohort. The sponsor indicated that not all of the CAC hips will be followed through 5 years, only those necessary to obtain the 100 unilateral C/C hip minimum per Sample size and power calculations are not provided in protocol.
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| Sample Size |
(1) Randomized Non-inflammatory Arthritis (RNIA) cohort includes 156 ceramic-on-ceramic (C/C) hips and 117 ceramic-on-polyethylene (C/P) hips that served as a control group. (2) the Randomized Inflammatory Arthritis (RIA) cohort includes 17 ceramic-on-ceramic hips and 11 ceramic-on-polyethylene hips. (3) the Revision Hip (RR) cohort includes 4 ceramic-on-ceramic hips and 3 ceramic-on-polyethylene hips. (4) The Continued Access Cohort (CAC) cohort includes of 159 ceramic-on-ceramic hips. The sponsor indicated that not all of the CAC hips will be followed through 5 years, only those necessary to obtain the 100 unilateral C/C hip minimum per Sample size and power calculations are not provided in protocol.
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| Key Study Endpoints |
The first five years of patient follow-up include clinical and radiographic examination. Endpoints include device revision and the determination of a Harris Hip Score. The final 5 years of follow-up is limited to a brief questionnaire. Endpoints encompass patient satisfaction and the incidence of device revision.
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| Follow-up Visits and Length of Follow-up |
Patients are seen annually for clinical and radiographic examinations during the first five years of follow-up and then receive questionnaires annually during the last 5 years of follow-up.
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| Interim or Final Data Summary |
| Interim Results |
No significant differences in questionnaire responses regarding hip removal, patient satisfaction, or plans to remove the hips in the next year were observed between the ceramic-on-ceramic and ceramic-on-polyethylene groups during years 6 through 10 of patient follow-up. .
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| Actual Number of Patients Enrolled |
The study population consisted of 364 ceramic-on-ceramic hips and 144 ceramic-on- polyethylene hips.
|
| Actual Number of Sites Enrolled |
A total of 9 clinical sites enrolled study subjects.
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| Patient Follow-up Rate |
The follow-up rate in the study at 10 years was 71.1% for the ceramic-on-ceramic hip group and 47.2%
for the ceramic-on-polyethylene group.
|
| Final Safety Findings |
There was no statistically significant difference at 10 post-operative years in device survival between the ceramic-on-ceramic group, 91.1% and the control ceramic-on-polyethylene group,
90.2%, p = 0.66.
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| Final Effect Findings |
Tabulation of postcard responses at 6, 7, 8, 9 and 10 year intervals revealed that consistently more than 90% of respondents were satisfied with their hip throughout the follow-up years of the study in both treatment groups. At the 10 year interval 92.0% (206/224) of subjects in the C/C group and 93.3% (56/60) of subjects in the C/P groups reported that they were satisfied with their hip.
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| Study Strengths & Weaknesses |
An important study strength was the inclusion of a concurrent control group. A study weakness was the sub-optimal follow-up rates for both the ceramic-on-ceramic and ceramic-on-polyethylene groups. The follow-up rate at 10 years was 71.1% for the ceramic-on-ceramic group and 47.2% for the ceramic-on-polyethylene group. The low follow-up rates are a potential source of bias in the study as the device experience for the patients who were lost to follow-up may have differed from their counterparts who remained in the study.
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| Recommendations for Labeling Changes |
The labeling should be changed to reflect the data noted above.
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