Post- Approval Hintermann Series H® Study 1

NCT06514196 | Active Not Recruiting FDA Device

• 1 other identifier: PAS 001
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Hintermann Series H3 Total Ankle Replacement System DEVICE

The H3 includes a metal tibial component, a polyethylene sliding insert (PE inlay), and a metal talar component.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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),
• rd 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)

You may not qualify if:

• Prior TAR or arthrodesis at the involved ankle joint

Sponsors & Collaborators

• DT MedTech, LLC: lead

Study Sites (1)

Kantonsspital Baselland

Bruderholz, CH-4101, Switzerland

Location

Study Officials

• Beat Hintermann

  Cantonal Hosptal, Baselland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 23, 2024
• Study Start: June 18, 2020
• Primary Completion: November 30, 2024
• Study Completion: January 20, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CH (1)