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

Trial Summary

What is the purpose of this trial?

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 submission of periodic reports (Annual Report), required under 21 CFR 814.84. In order to provide continued reasonable assurance of the safety and effectiveness of the PMA device, data from this post-approval study must be submitted to FDA in a PMA Post-Approval Study Report per the requirements set forth in the approval.

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 data supports the effectiveness of the Hintermann Series H3 Total Ankle Replacement System treatment?

Research shows that the HINTEGRA total ankle replacement, which is similar to the Hintermann Series H3, has been used successfully for end-stage ankle arthritis, providing good functional outcomes and implant survivorship over several years. Studies indicate that it offers stability and natural movement, making it a valuable option for patients with severe ankle arthritis. ^{1 2 3 4 5}

Is the HINTEGRA total ankle replacement system safe for humans?

The HINTEGRA total ankle replacement system has been used worldwide since 2000, with studies showing varied outcomes. Some studies report issues like periprosthetic cyst formation and reoperation rates, but overall, it has been widely used for ankle arthroplasty with a focus on improving ankle function and stability. ^{1 2 3 4 5}

How does the Hintermann Series H3 Total Ankle Replacement System differ from other treatments for ankle osteoarthritis?

The Hintermann Series H3 Total Ankle Replacement System is unique because it is an unconstrained, three-component system that allows for more natural ankle movement, including inversion-eversion stability and axial rotation, which can lead to better functional outcomes compared to other treatments like ankle fusion. ^{1 2 3 4 5}

Research Team

Melanie Tuznik

Principal Investigator

DT MedTech

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of the HINTEGRA and Mobility total ankle replacements. Short- to intermediate-term outcomes. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Intermediate-term Results of Mobile-bearing Total Ankle Replacement. [2016]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Total ankle replacement using HINTEGRA, an unconstrained, three-component system: surgical technique and pitfalls. [2022]

5. Germany 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. [2021]