ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Last updated: February 8, 2022
Sponsor: University of Virginia
Overall Status: Active - Enrolling

Phase

4

Condition

Holoprosencephaly

Birth Defects

Treatment

N/A

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 to surgery
  • 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
Study Start date:
October 23, 2018
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Site Not Available

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