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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P160036 / PAS002 |
| Date Original Protocol Accepted |
11/29/2019
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| Date Current Protocol Accepted |
09/20/2024
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| Study Name |
Hintermann Series H3 TAR Performance Study
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| Device Name |
Hintermann Series H3 Total Ankle Replacement System
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
External Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: The purpose of this multi-center post-approval study is to meet the conditions of the PMA approval for the H3 TAR, to evaluate the trends in performance among implant sizes, and to assess the outcomes of the primary surgeon of the premarket study that supported PMA approval, compared to other surgeons that are less familiar with the device. Design: Prospective multicenter single arm post approval study with data supplementation from the UK National Joint Registry (UK NJR).
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| Study Population |
Patients who have discussed options for management of a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis, or arthritis secondary to inflammatory disease (e.g., rheumatoid arthritis, hemochromatosis, etc.), and who have decided to undergo total ankle replacement, are candidates for this study.
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| Sample Size |
US Population: 94 subjects/ 10 Clinical Sites
UK Population: 407 subjects / 45 Clinical Sites
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| Key Study Endpoints |
Primary Endpoints for US population:
• Survivorship (absence of revision to metal components only)
• Survivorship (absence of revision to metal and polyethylene components)
Additional Endpoints for US population:
• American Orthopaedic Foot and Ankle Society (AOFAS) score at 2 years or more
• Percentage of subjects with a serious device related adverse event, other than a revision or removal within 2 years
• Incidence, occurrence, and types of serious device related adverse events
• Nature, onset, duration, severity, relationship to the device, relationship to the operative procedure, and outcome of any adverse event
• Visual Analog Scale (VAS) score
• Subjects Satisfaction Surverys
• SF-36
• Radiographs (loosening, osteolysis, implant migration, other findings)
• Explant analysis
UK population:
• Survivorship (absence of revision to metal components only)
• Survivorship (absence of revision to metal and polyethylene components)
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
US data: Twenty-six (26) operative site events representing 29.2% (26/89), and eight (8) systemic events representing 9% (8/89) were reported. There have been three (3) revisions and five (5) removals. No deaths have occurred since the study started.
UK Registry data: There have been twenty-eight (28) reported revision surgeries in this cohort.
Effectiveness Results:
US data: AOFAS Alignment Score patients rated fair/good: at baseline 70.7% (58/82), 6-week 95.2% (60/63), 24-week 100% (45/45), 1-year 100% (12/12), and 2-year 100% (2/2).
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| Actual Number of Patients Enrolled |
101 US subjects/ 407 UK subjects
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| Actual Number of Sites Enrolled |
13 US subjects / 45 UK sites
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| Patient Follow-up Rate |
US data: Follow-up rate (All data available per protocol) is 56.8% (50/88) at 6 weeks, 48.6% (36/74) at 24 weeks, 18.6% (8/43) at 1-year, and 50% (1/2) at 2-year.
UK Registry data: The Kaplan-Meier estimate of survivorship at 5 years is 94.5% with a 95% confidence interval of (91.5%, 96.5%). At 10 years, the Kaplan-Meier estimate of survivorship is 91.3% with a 95% confidence interval of (87.4%, 94.0%).
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