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Post- Approval Hintermann Series H® Study 1

NCT06514196 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 298

Last updated 2024-07-23

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • DT MedTech, LLC

    lead INDUSTRY

Principal Investigators

  • Beat Hintermann · Cantonal Hosptal, Baselland

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2024-11-30
Completion
2025-01-20
FDA Device
Yes

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06514196 on ClinicalTrials.gov