What is the mechanism of action of this treatment?

Common treatments for ankle arthritis, especially those involving bone fusion, include the use of cellular bone matrices like ViviGen. These treatments work by providing a scaffold that supports new bone growth, incorporating osteogenic (bone-forming) cells, and osteoinductive (bone-stimulating) factors. This is crucial for patients with ankle arthritis as it promotes the fusion of bones in the affected joint, reducing pain and improving stability and function. By enhancing the body's natural bone healing processes, these treatments can lead to better outcomes and faster recovery times compared to traditional bone grafts.

What side effects are associated with this type of intervention?

Common treatments for ankle arthritis, particularly those involving bone fusion, include surgical procedures like arthrodesis and the use of bone grafts such as cellular bone matrices. Known side effects of these treatments can include infection, nonunion (failure of the bone to heal), and complications related to the surgical procedure itself, such as nerve damage or blood clots. Additionally, patients may experience pain and swelling at the graft site. While specific side effects for ViviGen are not detailed, these general risks are associated with similar bone fusion treatments.

What prior FDA approvals exist?

FDA-approved treatments for ankle arthritis, particularly those involving bone fusion, include various bone graft substitutes and cellular bone matrices. These treatments aim to promote bone healing and fusion in arthrodesis procedures. ViviGen Cellular Bone Matrix is one such product, approved for use in hindfoot or ankle arthrodesis as an alternative to autografts. Other similar treatments may include synthetic bone grafts and demineralized bone matrices, which are designed to support bone regeneration and provide a scaffold for new bone growth.

What other types of research exist?

Promising novel alternatives to ViviGen for ankle arthritis patients include: 1) MSC-derived extracellular vesicles (EVs) which are gaining ground for their potential in articular tissue regeneration, 2) Hyaluronic Acid (HA) injections, which have shown efficacy in treating orthopedic conditions like osteochondral lesions and tendinopathies, and 3) Mini implants made of polylactide, which are being explored as alternatives to total joint replacement or joint fusion for severe osteochondral defects.

← Back to Search

Cellular Bone Matrix

ViviGen for Ankle Arthritis (ViviGen Trial)

Phase 4

Waitlist Available

Led By Joseph Park, MD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing how well the ViviGen graft, a special bone graft with living cells, helps patients who need their hindfoot bones to fuse together. ViviGen is used instead of taking bone from another part of the body.

Who is the study for?

This trial is for adults aged 18-80 who need a hindfoot ankle arthrodesis procedure and can follow up with evaluations. It's not for those with high blood sugar levels, large bone defects, weak bones, previous foot fusion or infection at the surgery site, inability to stay off the foot after surgery, vitamin D deficiency, recent tobacco use, or a BMI over 40.

What is being tested?

The study tests ViviGen Cellular Bone Matrix in patients undergoing hindfoot or ankle fusion surgery. The goal is to see if ViviGen helps bones fuse together as an alternative to using the patient's own bone tissue (autograft).

What are the potential side effects?

While specific side effects of ViviGen are not listed here, similar treatments may cause local reactions at the graft site like pain or swelling and could potentially lead to complications in bone healing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fusion

Secondary study objectives

American Orthopaedic Foot and Ankle Society(AOFAS) hindfoot score

Failure of hardware or obvious non-union

Ankle

+4 more

Awards & Highlights

No Placebo-Only Group

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ViviGen Cellular Bone MatrixExperimental Treatment1 Intervention

Patients will receive the vivigen cellular bone matrix

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ViviGen

2016

N/A

~100

Do I qualify?Apply below to find out

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

Common treatments for ankle arthritis, especially those involving bone fusion, include the use of cellular bone matrices like ViviGen. These treatments work by providing a scaffold that supports new bone growth, incorporating osteogenic (bone-forming) cells, and osteoinductive (bone-stimulating) factors. This is crucial for patients with ankle arthritis as it promotes the fusion of bones in the affected joint, reducing pain and improving stability and function. By enhancing the body's natural bone healing processes, these treatments can lead to better outcomes and faster recovery times compared to traditional bone grafts.

Common Transcriptomic Effects of Abatacept and Other DMARDs on Rheumatoid Arthritis Synovial Tissue.Anti-TNF effects on destructive fibroblasts depend on mechanical stress.Visualization and in situ analysis of leukocyte trafficking into the ankle joint in a systemic murine model of rheumatoid arthritis.