ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Last updated: June 17, 2025
Sponsor: University of Virginia
Overall Status: Completed

Phase

N/A

Condition

Joint Injuries

Birth Defects

Holoprosencephaly

Treatment

ViviGen

Clinical Study ID

NCT04138017
20532
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with prescribed standard of care unilateral hindfoot ankle arthrodesisprocedure

  • Age 18-80

  • Willing to complete all follow up evaluations

Exclusion

Exclusion Criteria:

  • Prior infection at site of planned arthrodesis

  • Prior arthrodesis procedure

  • Inability to maintain non-weight bearing status

  • Bone defect requiring more than 10 cc of bone graft material

  • Known Vitamin D deficiency with a Vitamin D level of <30ng/ml 1 week prior tosurgery

  • Inadequate bone stock to allow for rigid internal fixation

  • Hemoglobin A1c greater than 8.0%

  • Tobacco or Nicotine use 6 weeks prior to surgery

  • BMI greater than 40

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: ViviGen
Phase:
Study Start date:
October 23, 2018
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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