Trials / Completed
CompletedNCT04138017
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- University of Virginia · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ViviGen | A cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells. |
Timeline
- Start date
- 2018-10-23
- Primary completion
- 2023-04-10
- Completion
- 2023-12-01
- First posted
- 2019-10-24
- Last updated
- 2025-06-19
- Results posted
- 2025-06-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04138017. Inclusion in this directory is not an endorsement.