NCT06514196

Post- Approval Hintermann Series H® Study 1

Post- Approval Study 1: Long Term Follow Up of the Hintermann Series H® Total Ankle Replacement System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 298 (estimated)
• Sponsor: DT MedTech, LLC · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The H3 TAR device received U.S. 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.

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 (e.g., 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 revision/removal 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.

Conditions

• Ankle Osteoarthritis
• Post-Traumatic Osteoarthritis of Ankle
• Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)

Interventions

Type	Name	Description
DEVICE	Hintermann Series H3 Total Ankle Replacement System	The H3 includes a metal tibial component, a polyethylene sliding insert (PE inlay), and a metal talar component.

Timeline

• Start date: 2020-06-18
• Primary completion: 2024-11-30
• Completion: 2025-01-20
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study