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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P150030 / PAS002 |
| Date Original Protocol Accepted |
10/17/2016
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| Date Current Protocol Accepted |
01/19/2024
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| Study Name |
Short to Mid-Term f/u of New US Patients
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| Device Name |
R3 DELTA CERAMIC HIP SYSTEM
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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 |
Historical Control
|
| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Study Objective: The primary objective is to confirm that the safety and effectiveness of the R3 Biolox delta Ceramic Acetabular System in the US population is consistent with the effectiveness and safety profile shown in the European study (PMA cohort).
Study Design: Prospective, multicenter, observational study
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| Study Population |
The study population is comprised of US patients who receive the device in the post-market environment. The comparator group is comprised of patients in the European premarket cohort. Subject must meet all of the following inclusion criteria in order to be enrolled in this study.
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| Sample Size |
Number of Subjects: 183
Assumptions for sample size estimation: The sample size calculation included assumption of an overall success rate of 86.4% at 3 years post surgery for the Biolox delta ceramic-on-ceramic (DOD) treatment group. The delta was equivalent to 8%. For a power of 80% and a one-sided type 1 error of 5%, 146 subjects are needed. The total sample size after adjustment for 20% lost to follow-up is 183 subjects. The sample size was calculated assuming use of an Exact Binomial test.
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| Key Study Endpoints |
Primary Endpoint: Overall success at 3 years postoperative, defined as:
• No component revision
• Modified Harris Hip Score (mHHS) of at least 80 points, and
• No radiographic failure defined as no radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degrees from baseline when accompanied by a “mild”, “moderate”, “marked”, or “disabled” mHHS pain score.
Secondary Endpoints: Clinical assessments of pain and function using the modified Harris Hip Score, radiographic findings and implant survivorship.
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| Follow-up Visits and Length of Follow-up |
3 years
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| Interim or Final Data Summary |
| Interim Results |
Number of study sites enrolled 10 sites
Number of subjects enrolled 189 subjects
Follow-up rate Complete follow-up of patients at 3-years is 90/161 (56%)
Summary of Interim Results
There were no reports of unanticipated adverse device effects.
Four (4) deaths occurred, One (1) failure and revision for recurrent dislocation
Strengths and Weaknesses
A strength of the study is its adequate power to detect differences in short-term device survival between the US post-market cohort and the European ore-market cohort. A weakness of the study is the absence of long-term follow-up to assess long-term device performance
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