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ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

NCT04138017 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2025-06-19

Study results available
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Summary

To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.

Conditions

  • Ankle Deformity
  • Ankle Arthritis

Interventions

DEVICE

ViviGen

A cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells.

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Joseph Park, MD · University of Virginia

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-23
Primary Completion
2023-04-10
Completion
2023-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138017 on ClinicalTrials.gov