Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514196
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-20
Brief Title:
Post- Approval Hintermann Series H Study 1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Post- Approval Study 1 Long Term Follow Up of the Hintermann Series H Total Ankle Replacement System
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The H3 TAR device received US Food and Drug Administration FDA Premarket Approval PMA on June 4 2019 and as a condition of that approval this study is being conducted to provide long-term safety and effectiveness of the H3 TAR System among patients included in the Primary Safety and Effectiveness PSE Cohort P1600361
This will be a Prospective single-center single arm study
This will be a Prospective single-center single arm study
Detailed Description:
The Hintermann Series H3 H3 prosthesis is a mobile bearing total ankle replacement TAR indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis post-traumatic osteoarthritis or arthritis secondary to inflammatory disease eg rheumatoid arthritis hemochromatosis etc
This will be a Prospective single-center single arm study All living subjects who participated in the PSE cohort regardless of whether or not the subject has had a revisionremoval followed through the 10-year post-operation visit 298 subjects were originally included in the PSE cohort
Through 10 years follow up Based on the last surgery date it is projected the study will be completed with the final 10-year follow-up visit to occur in December 2024
Patients will undergo clinical and radiographic evaluation at 5 and 10 years - 90 days post-operation
Performance Goals PGs will be constructed for the 10-year endpoint As with the PGs used in the PMA study these will be based on a prospectively defined systematic meta-analysis of available published literature and registry data for the control a legally marketed mobile bearing ankle The details of the meta-analysis will be pre-specified in a protocol for this purpose Both the protocol and the meta-analysis will be completed prior to the completion of the study
This will be a Prospective single-center single arm study All living subjects who participated in the PSE cohort regardless of whether or not the subject has had a revisionremoval followed through the 10-year post-operation visit 298 subjects were originally included in the PSE cohort
Through 10 years follow up Based on the last surgery date it is projected the study will be completed with the final 10-year follow-up visit to occur in December 2024
Patients will undergo clinical and radiographic evaluation at 5 and 10 years - 90 days post-operation
Performance Goals PGs will be constructed for the 10-year endpoint As with the PGs used in the PMA study these will be based on a prospectively defined systematic meta-analysis of available published literature and registry data for the control a legally marketed mobile bearing ankle The details of the meta-analysis will be pre-specified in a protocol for this purpose Both the protocol and the meta-analysis will be completed prior to the completion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None