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| General |
| Study Status |
Ongoing |
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
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| 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 |
| Actual Number of Patients Enrolled |
189 hips (Female: 110, Male: 79)
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| Actual Number of Sites Enrolled |
10 sites (US)
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| Patient Follow-up Rate |
The 3-year follow-up rate for subjects with all primary and secondary endpoints data is 65.8% (121/184) (all patients who completed the study within and beyond the follow-up window were considered).
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| Final Safety Findings |
A total of 123 (65%) hips had adverse event data by 3 years of follow-up. There were 4 deaths (2.1%) unrelated to the device or procedure. There were 7 device-related adverse events (AEs) in 5.7% (7/123) of hips. There were no unanticipated adverse device effects. The most frequently reported device-related AEs were hip squeaking/clicking/popping/snapping or other noise. There were 24 procedure-related adverse events (AEs) in 19.5% (24/123) of hips, and one (1) hip revision (0.5%) due to recurrent dislocation related to procedure but not related to device. The most frequently reported procedure-related AEs were bursitis, and muscular/connective tissue.
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| Final Effect Findings |
Survivorship: At 3-years post-surgery, Kaplan-Meier implant survivorship is estimated as 99.4% (95% confidence interval: 96.1%- 99.9%). Functional Outcomes: At 3-years of follow up, 91.9% (114/124) of patients were reported to have ‘Excellent’ or ‘Good’ modified Harris Hip Score (mHHS) (score >80) and 4.8% (6/124) were reported to have ‘Poor’ mHHS (score 60-69). Radiographic Outcomes: At 3-years post-surgery, • Absence of radiolucencies greater than 2 mm in 50% or more of the cup or stem zones (100% for a total of 119 hips) • Absence of migration or subsidence of the cup or stem greater than or equal to 5 mm (100% for a total of 119 hips) • Absence of cup inclination changes greater than 4 degrees from baseline when accompanied by a “Mild”, “Moderate”, “Marked” or “Disabled” mHHS pain score (98.1% for a total of 108 hips)
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| Study Strengths & Weaknesses |
Strengths: The US study was able to demonstrate short- to mid-term device safety and effectiveness through 3 years post-surgery. Overall study success was determinable for 113 subjects. 88.5% (100/113) of these subjects met clinical success at 3 years with a 95% confidence interval from 81.1 to 93.7%. Weaknesses: High loss to follow-up or missing study success data (e.g., radiographic, mHHS, and AEs) for 40.2% (76/189) of subjects at 3 years. Caution is advised in generalization of these results to broader US patients or practice.
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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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