What is the mechanism of action of this treatment?

The Zimmer Trabecular Metal Total Ankle implant, like other joint replacement therapies, works by providing structural support and facilitating joint function. These implants replace damaged joint surfaces with metal and plastic components, which help to restore mobility and reduce pain. The metal components offer durability and stability, while the plastic parts mimic the cushioning effect of cartilage. This is crucial for arthritis patients as it directly addresses joint degradation, alleviates pain, and improves overall joint function, thereby enhancing the patient's quality of life.

What side effects are associated with this type of intervention?

Common treatments for arthritis, particularly surgical interventions like total ankle arthroplasty, can lead to complications such as infection, thromboembolic disease, and implant loosening. Pharmacological treatments, including methotrexate and biologic DMARDs, may cause liver toxicity, bone marrow suppression, and increased risk of infections. Newer investigational drugs like anti-NGF agents have been associated with rapidly progressive osteoarthritis and nervous system issues.

What prior FDA approvals exist?

The FDA has approved several treatments for arthritis that provide structural support and facilitate joint function. Notably, total joint arthroplasty implants, such as the Zimmer Trabecular Metal Total Ankle implant, are designed to replace damaged joints and improve mobility. Additionally, biologic agents like TNF inhibitors (e.g., infliximab, adalimumab) and JAK inhibitors (e.g., tofacitinib) have been approved to manage rheumatoid arthritis by reducing inflammation and preventing joint damage. These treatments collectively aim to enhance joint function and quality of life for arthritis patients.

What other types of research exist?

Promising alternatives to the Zimmer Trabecular Metal Total Ankle implant for arthritis patients include the use of topologically optimized models and rational inner scaffold designs. These alternatives focus on patient customization, weight reduction, and mechanical stability, which are crucial for improving clinical outcomes in total ankle arthroplasty.

← Back to Search

Orthopedic Implant

Ankle Implant for Arthritis

N/A

Waitlist Available

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient is > 18 years of age

The patient is skeletally mature

Must not have

The patient has ankle arthrodesis with malleolar exeresis, severe neurological or vascular disease, loss of musculature or neuromuscular compromise, severe instability, maltracking or misalignment of the tibia and talus uncorrectable by surgery compromising the affected limb

The patient has insufficient bone stock or bone quality to fix the components (i.e. osteoporosis, Charcot's disease)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a special ankle implant for patients needing ankle surgery. It aims to see how well the implant works in reducing pain and improving function. The implants have been developed to improve stability and longevity, with advancements in design and materials.

Who is the study for?

This trial is for adults over 18 with arthritis (degenerative, rheumatoid, or post-traumatic) who need ankle replacement surgery. They must be able to consent and follow the study's procedures. Excluded are prisoners, those mentally unable to participate, non-compliant individuals, pregnant women, patients with infections or poor bone quality, and those with severe limb issues.

What is being tested?

The Zimmer Trabecular Metal Total Ankle System is being tested in people needing ankle replacements due to arthritis. The study aims to track how well the implant works by looking at pain relief, improved function, life quality measures and checking x-rays for durability.

What are the potential side effects?

While not explicitly listed here, potential side effects may include pain at the implant site, swelling of the affected limb(s), infection risks around the new joint and possible allergic reactions if sensitive to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

My bones have stopped growing.

Select...

I am eligible for an ankle replacement due to arthritis or injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe ankle issues or nerve/blood vessel diseases affecting my leg.

Select...

My bones are too weak or damaged to support surgical implants.

Select...

I have had an infection in my joint before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Survivorship

Secondary study objectives

American Orthopaedic Foot and Ankle Society Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zimmer TM Total Ankle SystemExperimental Treatment1 Intervention

Primary or revision total ankle arthroplasty subjects that receive the Zimmer Trabecular Metal Total Ankle System

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Zimmer Trabecular Metal Total Ankle implant, like other joint replacement therapies, works by providing structural support and facilitating joint function. These implants replace damaged joint surfaces with metal and plastic components, which help to restore mobility and reduce pain. The metal components offer durability and stability, while the plastic parts mimic the cushioning effect of cartilage. This is crucial for arthritis patients as it directly addresses joint degradation, alleviates pain, and improves overall joint function, thereby enhancing the patient's quality of life.

Joint damage in rheumatoid arthritis: radiological assessments and the effects of anti-rheumatic drugs.Current evidence for a strategic approach to the management of rheumatoid arthritis with disease-modifying antirheumatic drugs: a systematic literature review informing the EULAR recommendations for the management of rheumatoid arthritis.Occupational therapy for rheumatoid arthritis.