N/A N=15

ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

Ankle Deformity · Ankle Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT04138017 ↗

Enrolled (actual)

Serious AEs

6.7%

Results posted

Jun 2025

Primary outcome: Primary: Union Rates — 23 joints fused

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: ViviGen (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Virginia
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Union Rates	23	—
SECONDARY Failure of Hardware or Obvious Non-union	7	—
SECONDARY Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale	53.52; 61.09; 73.30; 80.69	—
SECONDARY Vitamin D Levels	48.17; 55.86	—
SECONDARY American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score	48.93; 64.71; 69.43; 79.85	—

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 Criteria

Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
Age 18-80
Willing to complete all follow up evaluations

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04138017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.