CompletedNot Applicable

ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis

United States15 participantsStarted 2018-10-23

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Union Rates

Timeframe: 12 months

Trial details

NCT IDNCT04138017

SponsorUniversity of Virginia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-10

Results submitted2025-05-21

View on ClinicalTrials.gov More Ankle Deformity trials