Ankle Replacement for Osteoarthritis

Recruiting at 9 trial locations

Overseen By In House Clinical Research Associate

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DT MedTech, LLC

Must not be taking: Immunosuppressants

Disqualifiers: Skeletal immaturity, Poor bone quality, Neuromuscular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate post-operative period

232 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of the Hintermann Series H3 Total Ankle Replacement System for individuals with ankle osteoarthritis. It targets those with arthritis types, such as primary, post-traumatic, or inflammatory-related, that make walking difficult due to worn-out ankle joints. Participants must be willing to attend follow-up visits and allow the sharing of their health data. Those with severe bone issues, infections, or previous ankle surgeries may not be suitable for this trial. The researchers aim to ensure the ankle replacement system functions well and remains safe for future patients. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative treatments for ankle arthritis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy, you may not be eligible to participate.

What prior data suggests that the H3 TAR Prosthesis is safe for ankle replacement?

Research has shown that the FDA has approved the Hintermann Series H3 Total Ankle Replacement System, indicating it has passed certain safety checks. However, the FDA has noted a higher than expected risk of device malfunction over time. While many patients may not experience issues, there is a chance the device could fail.

The system is designed to replace painful arthritic ankle joints but is not suitable for everyone. Certain health conditions may make it inappropriate, so discussing its suitability with a healthcare provider is important.

In summary, the treatment is approved and generally considered safe, but potential risks should be considered before participating in any related clinical study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hintermann Series H3 Total Ankle Replacement System is unique because it offers a more anatomically accurate replication of the ankle joint compared to traditional ankle fusion and older replacement models. This system is designed to preserve natural movement and provide better stability and function for individuals with osteoarthritis. Researchers are excited about this treatment because it aims to improve patient outcomes by reducing pain and enhancing mobility without the limitations commonly associated with fusion procedures.

What evidence suggests that the Hintermann Series H3 Total Ankle Replacement System is effective for osteoarthritis?

Research shows that the Hintermann Series H3 Total Ankle Replacement system works well for people with painful arthritic ankle joints. The FDA has approved it, indicating its safety and effectiveness. Studies have found that this system improves joint function and reduces pain from osteoarthritis, a common type of ankle arthritis. Patients who have undergone this ankle replacement report satisfaction and long-term success. These findings suggest that the Hintermann Series H3 is a dependable choice for treating ankle arthritis. ^{1 3 4 5 6}

Who Is on the Research Team?

Melanie Tuznik

Principal Investigator

DT MedTech

Are You a Good Fit for This Trial?

This trial is for adults with ankle arthritis, including osteoarthritis or arthritis from injury or inflammatory disease. Candidates must be suitable for mobile bearing total ankle replacement (TAR) and willing to follow study procedures and visits. Excluded are those with immature skeletons, poor bone quality, certain circulatory issues, high-impact sports activities, metal allergies, significant risk factors as assessed by a physician, severe limb misalignment or deformity, inadequate ligament support that can't be fixed surgically, neuromuscular diseases affecting the ankle function, prior deep infections in the area or previous ankle surgeries like fusion.

Inclusion Criteria

Written informed consent, including authorization to release collected health data

Willingness to participate in the study and follow-up visits

I have arthritis suitable for total ankle replacement as decided by my doctor.

Exclusion Criteria

The skin and tissue around my surgery area are in poor condition.

My legs have poor blood flow as shown by a Doppler test.

My bones are too weak to support a medical device due to severe osteoporosis or similar conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Hintermann Series H3 Total Ankle Replacement System

Surgery and immediate post-operative period

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Hintermann Series H3 Total Ankle Replacement System

Trial Overview

The Hintermann Series H3 Total Ankle Replacement System is being evaluated post-FDA approval to ensure ongoing safety and effectiveness. This involves collecting data on how well it works in patients who have received this implant as part of their treatment for various types of ankle arthritis.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

All subjects who meet eligibility, consented, and enrolled into the study will receive treatment.

Hintermann Series H3 Total Ankle Replacement System is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Hintermann Series H3 for:

• Primary osteoarthritis
• Post-traumatic osteoarthritis
• Arthritis secondary to inflammatory disease

Approved in European Union as Hintermann Series H3 for:

• Primary osteoarthritis
• Post-traumatic osteoarthritis
• Arthritis secondary to inflammatory disease

Approved in Canada as Hintermann Series H3 for:

• Primary osteoarthritis
• Post-traumatic osteoarthritis
• Arthritis secondary to inflammatory disease

Who Is Running the Clinical Trial?

DT MedTech, LLC

Lead Sponsor

Trials

2

Recruited

530+

Published Research Related to This Trial

In a study of 70 patients who received the Hintegra total ankle replacement (TAR) with an average follow-up of 76 months, the implant survivorship rate was found to be 81.7%, indicating a reasonable long-term success rate for this procedure.

The study also revealed a high incidence of periprosthetic cysts (40% of patients), which led to reoperations in some cases, suggesting the need for ongoing monitoring of patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Hintegra total ankle replacement: survivorship, failure modes and patient reported outcomes in seventy consecutive cases with a minimum five year follow-up. Clifton, LJ., Kingman, A., Rushton, PRP., et al.[2021]

Total ankle replacement (TAR) using the HINTEGRA prosthesis showed similar short-term clinical outcomes to arthroscopic ankle arthrodesis (AAA) and open ankle arthrodesis (OAA) in patients with end-stage ankle arthritis, with significant improvements in pain and disability scores for TAR and AAA compared to OAA.

However, TAR had a higher rate of reoperations compared to AAA and OAA, indicating that while TAR can be effective, patients should be informed about the potential for more additional procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Total Ankle Replacement, Arthroscopic Ankle Arthrodesis, and Open Ankle Arthrodesis for Isolated Non-Deformed End-Stage Ankle Arthritis. Veljkovic, AN., Daniels, TR., Glazebrook, MA., et al.[2020]

In a study comparing 32 HINTEGRA total ankle replacements (TARs) and 35 Mobility TARs, both groups showed similar outcomes in terms of pain, function, and range of motion after a minimum follow-up of two years, indicating comparable efficacy of the two implant types.

Heterotopic ossification (HO) was more common in the HINTEGRA group, with 40.6% of patients affected compared to 20.0% in the Mobility group, suggesting a potential safety concern, although this difference was not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the HINTEGRA and Mobility total ankle replacements. Short- to intermediate-term outcomes. Choi, GW., Kim, HJ., Yeo, ED., et al.[2016]

In a study of 50 patients who underwent total ankle replacement (TAR) with the HINTEGRA system, significant improvements were observed in clinical outcomes, with the AOFAS Ankle-Hindfoot Scale score rising from 43.5 to 83.8 post-surgery over a mean follow-up of 45 months.

Despite satisfactory clinical results, the study found a high incidence of asymptomatic periprosthetic osteolytic lesions in 24 ankles, and a 10% failure rate requiring major revision surgery within 4 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-term Results of Mobile-bearing Total Ankle Replacement. Deleu, PA., Devos Bevernage, B., Gombault, V., et al.[2016]

The HINTEGRA total ankle replacement (TAR) system is designed to mimic natural ankle biomechanics, offering improved stability and mobility for patients with end-stage ankle osteoarthritis.

This prosthesis features anatomically contoured metal components and a polyethylene insert, allowing for axial rotation and physiologic flexion-extension, making it suitable for complex hindfoot reconstructions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total ankle replacement using HINTEGRA, an unconstrained, three-component system: surgical technique and pitfalls. Barg, A., Knupp, M., Henninger, HB., et al.[2022]

Citations

1.

fda.gov

fda.gov/medical-devices/safety-communications/hintermann-series-h3-total-ankle-replacement-has-higher-expected-risk-device-failure-fda-safety

Hintermann Series H3 Total Ankle Replacement ... - FDA

The FDA is providing an update on post-approval study data for the Hintermann Series H3 Total Ankle Replacement (TAR) system.

2.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160036d.pdf

Hintermann Series H3™ Total Ankle Replacement System

The Hintermann Series H3™ TAR is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post- ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04770870?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22DT%20MedTech,%20LLC%22))&rank=2

Post Approval Study2: Hintermann Series H3 Total Ankle ...

The H3 TAR Prosthesis was approved by FDA (P160036) on June 4, 2019. Continued approval of the premarket approval application (PMA) is contingent upon the ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40078627/

Hintegra® total ankle replacement. Five and 10 year ...

Our results show that the Hintegra® TAR prosthesis leads to good medium to long term survivorship and acceptable patient satisfaction rates.

5.

assets.hpra.ie

assets.hpra.ie/data/docs/default-source/product-updates/fsn/field-safety-notices/april-2025/hintermann-series-h3-total-ankle-replacement-(tar)-system_dt-medtech-_advice-regarding-the-use-of-the-device.pdf?sfvrsn=f78b209a_1

Hintermann Series H3 TAR system

Total Ankle Replacement System clinical data and published clinical literature for clinical experiences within the same patient population.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160036b.pdf

summary of safety and effectiveness data (ssed)

The Hintermann Series H3™ Total Ankle Replacement prosthesis should not be implanted in patients with the following conditions:.