Post- Approval Hintermann Series H® Study 1

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ankle Osteoarthritis; Post-Traumatic Osteoarthritis of Ankle; Osteoarthritis of Ankle Secondary to Inflammatory Arthritis (Disorder)
• Intervention / Treatment: Device: Hintermann Series H3 Total Ankle Replacement System

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.

• Study Type: Observational
• Enrollment (Estimated): 298

Contacts and Locations

Study Locations

• Switzerland
  • Bruderholz, Switzerland, CH-4101
    • Kantonsspital Baselland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of all living subjects who participated in the PSE cohort, regardless of whether or not the subject has had a removal/revision followed through the 10-year post-operation visit.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AOFAS Score Measurement	The American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Score is among will be used for measuring the outcome of treatment in patients who sustained a complex ankle or hindfoot injury. It will be measured at a minimum 10 years post-operation	10 Years
Survivorship Measurement	Survivorship (absence of removal/revisions to include polyethylene revision) will be recorded at 10 years from surgery	10 Years
Serious device-related adverse event Measurement	Percentage of subjects with a serious device-related adverse event, other than a revision or removal will be calculated at 10 years from surgery	10 Years
Reoperation, revisions or removals Measurement	Safety Reporting of the reoperation, revisions or removals of the Hintermann Ankle device will be reviewed and analyzed	10 Years
Serious Device-Related Adverse Events Measurement	Incidence, occurrence, and types of serious device-related adverse events will be reviewed and analyzed for subjects Nature, onset, duration, severity, relationship to the device, and relationship to the operative procedure and outcome of any adverse event will be measured.	10 Years
Device Explant Analysis Measurement	Any explanted devices / device components will be returned and handled for analysis as described in Attachment G: Explant and Revision Protocol, to be examined for wear and damage.	Through Study Completion an Average of 10 years

Collaborators and Investigators

• Sponsor: DT MedTech, LLC
• Investigators: Principal Investigator: Beat Hintermann, Cantonal Hosptal, Baselland

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2020
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): January 20, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: PAS 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes