Post- Approval Hintermann Series H® Study 1

NCT ID: NCT06514196

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 298 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2025-01-20

Brief 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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Skeletally mature
• Primary diagnosis of osteoarthritis, post-traumatic arthritis or rheumatoid arthritis
• Primary total ankle replacement
• Unilateral or the first ankle implanted if bilateral and the surgery dates for both sides are at least 6 months apart
• Implanted with the correct device without screws (for investigational arm),
• 3rd generation Hintermann Series H3 Total Ankle Replacement;
• Poor pre-operative American Orthopaedic Foot and Ankle Society Hindfoot Score (< 60 points)
• Implanted in 2013 or earlier). Note that all subjects implanted in 2013 or earlier were included regardless of whether they were revised prior to the 2 year endpoint.
• Gave informed consent (unless IRB/Ethics Committee waived this requirement)

Exclusion Criteria

• Prior TAR or arthrodesis at the involved ankle joint

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DT MedTech, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beat Hintermann

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hosptal, Baselland

Locations

Kantonsspital Baselland

Bruderholz, , Switzerland

Countries

Switzerland

Other Identifiers

PAS 001

Identifier Type: -

Identifier Source: org_study_id