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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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