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| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P160036 / PAS001 |
| Date Original Protocol Accepted |
11/29/2019
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| Date Current Protocol Accepted |
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| Study Name |
Hintermann Series H3 TAR Long Term 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 Cohort Study
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| Data Source |
Other Data Source
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this single-center, single arm study is to determine the 10-year survivorship and effectiveness of total ankle arthroplasty using the H3 TAR System in comparison to historical literature controls for a legally marketed mobile bearing ankle.
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| Study Population |
Primary Safety and Effectiveness Cohort from the PMA
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| Sample Size |
All living subjects (n=298) from the Updated PSE cohort that were included in the PMA will continue to be followed until they reach the 10-year postoperative interval.
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| Key Study Endpoints |
The primary effectiveness measurement for this study is a composite of the following parameters:
AOFAS Score
Survivorship (absence of removal/revisions to include polyethylene revision),
Percentage of subjects with a serious device-related adverse event other than a revision or removal.
The primary safety endpoint for this study is the evaluation of reoperations, revisions, or removals of the H3 device occurring within 10 years of surgery.
Additional study endpoints are:
Incidence, occurrence, and types of serious device-related adverse events.
Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event.
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| Follow-up Visits and Length of Follow-up |
10 years
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| Interim or Final Data Summary |
| Interim Results |
There are no planned interim analyses intended to test hypotheses or modify the study. The following information is based on analysis of interim results from the most recent annual study report.
A total of 298 subjects were originally enrolled in the study. As of the date of the report (June 2, 2023), 249 subjects had at least 5 years of follow-up (out of an expected 277 subjects), which represents a 90% follow-up rate. FDA’s analysis of the data showed a revision rate of at least 16.1% (48/298) which included removals or revision of metal components, and a revision rate of at least 28.5% (85/298) when all types of revisions are included (including revisions of metal or Ultra High Molecular Weight Polyethylene (UHMWPE) component).
Limitations: Results summarized are interim data only. The study is a continued follow-up of the premarket cohort with the intent to follow subjects for 10 years post implantation, but only a minimum of 5 years of follow-up data is currently available. All subjects were enrolled at a single center located outside the US with approximately 80% of implantations performed by the same surgeon, which limits the generalizability of the study results to US patients and US clinical practice. Additional analyses are planned in the final report to assess the risk of revision.
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