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General |
Study Status |
Completed |
Application Number / Requirement Number |
P070026 S004/ PAS002 |
Date Original Protocol Accepted |
04/02/2013
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Date Current Protocol Accepted |
06/26/2020
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Study Name |
Short-Mid-Term F/u of New COC36 patients
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Device Name |
DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM
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Clinical Trial Number(s) |
NCT00953719
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
New Data Collection
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Comparison Group |
No Control
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Analysis Type |
Descriptive
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Detailed Study Protocol Parameters |
Study Objectives |
A prospective, non-controlled, non-randomized, multicenter study. A minimum of 170 subjects will be prospectively enrolled into the study. Study sites will be comprised of both IDE study sites, as well as newly recruited sites. Subjects will be seen for a preoperative (pre-op) clinic visit at the time of consent, and then at 6-weeks, 1-year, 2-years, 3-years, 4-years and a minimum of 5-years postoperatively (post-op). If Subjects are not willing or able to return for a clinical and radiographic follow-up in the 3- and/or 4-year interval, then a telephone interview may be utilized for the purpose of determining device survivorship/patient satisfaction and case report form (CRF) 4b will be used. It is anticipated that a minimum of 136 unrevised subjects in this PAS will have a minimum 5-year post-op clinic evaluation. Up to fifteen (15) sites will participate, consisting of up to 5 sites who participated in the IDE study and the remainder being newly recruited sites.
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Study Population |
Newly enrolled subjects at participating sites who meet the inclusion/exclusion criteria for this study.
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Sample Size |
170 patients
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Key Study Endpoints |
Primary endpoint: Device survivorship, which will be estimated with a Kaplan-Meier survivorship analysis at 5-years post-operatively.
Secondary endpoints: Device survivorship will also be estimated at each year post- operatively. Harris Hip scores, Subject-hip outcomes, radiographic evaluation, and type and frequency of AEs will also be estimated at each year post-operatively.
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Follow-up Visits and Length of Follow-up |
Study Duration: The anticipated duration of this investigation is approximately seven years from the time of study initiation given that It may take up to a minimum of 2-years from the time of study initiation to enroll new subjects. Each subject will be followed until they have completed their minimum 5-year follow-up. The study will be closed when all subjects are at 5-years post-operatively.
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
172 hip procedures in 170 subjects (Female: 70, Male: 100)
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Actual Number of Sites Enrolled |
16 sites (US & Canada)
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Patient Follow-up Rate |
The 5-year follow-up rate for subjects with all primary and secondary endpoints data is 66% (107/163)
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Final Safety Findings |
A total of 134 hips (77.9%) had systemic adverse events (AE) and 105 hips (61.0%) had surgical site AEs data at 5 years of follow up. There were 2 deaths (1.2%) unrelated to the device or procedure and 8 revisions (4.7%) to femoral head, acetabular liner and/or acetabular cup and most revisions occurred within the first two (2) years of implantation. At 5 years of follow-up, there were: • 46 device related AEs at the surgical site in 19.2% (33/172) of hips. There were no unanticipated adverse device events. • 11 systemic procedure related AEs in 5.8% (10/172) of hips and 83 surgical site procedure related AEs in 32.0% (55/172) of hips. • The most frequently reported AEs were joint crepitation/noise/squeaking/grinding/vibration.
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Final Effect Findings |
Survivorship: At 5-years post-surgery, Kaplan-Meier implant survivorship is estimated as 94.9% (95% confidence interval: 90.0%- 97.4%). Functional Outcomes: At 5-years of follow up, 88% (96/109) of patients were reported to have ‘Excellent’ or ‘Good’ modified Harris Hip Score (mHHS) (score >80) and 4.6% (5/109) were reported to have ‘Poor’ mHHS (score <70). Radiographic Outcomes at 5 years: • For Acetabular Component, there were no cases of migration noted, 99.1% (108/109) had no radiolucency, 99.1% (108/109) had no osteolysis, 97.2% (106/109) with no sclerotic lines, and 97.2% (106/109) with no heterotopic ossification greater than grade III. • For Femoral Component, there were no cases of subsidence, osteolysis or radiolucency, 96.3% (105/109) with no heterotopic ossification greater than grade III, 92.7% (101/109) had no sclerotic lines, and 97.2% (106/109) had no calcar resorption
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Study Strengths & Weaknesses |
Strengths: The US and Canadian study was able to demonstrate device safety and effectiveness through 5 years post-surgery. Overall study success was determinable for 139 subjects. Weaknesses: High loss to follow-up or missing data (e.g., radiographic, mHHS) for 34.4% (56/163) of subjects at 5 years. Caution is advised in generalization of these results to broader US patients or practice. Of note, there were 14 (8.2% of 170) subjects that received one or more non-PMA device component(s) (i.e., femoral stem, femoral head, or acetabular cup), which may have influenced safety and effectiveness findings, which may have influenced safety and effectiveness findings.
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Recommendations for Labeling Changes |
Yes, a labeling change is recommended to update the device labeling with the final study results.
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