Status:
COMPLETED
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
DePuy Synthes
Conditions:
Ankle Deformity
Ankle Arthritis
Eligibility:
All Genders
18-80 years
Brief 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 alter...
Eligibility Criteria
Inclusion
- Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
- Age 18-80
- Willing to complete all follow up evaluations
Exclusion
- 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
Key Trial Info
Start Date :
October 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04138017
Start Date
October 23 2018
End Date
December 1 2023
Last Update
June 19 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22908