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NCT04138017 · ClinicalTrials.gov registry record
ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis
A clinical trial, sponsored by University of Virginia.
- Completed
- Registry status
- 15
- Enrollment target
NCT04138017: Completed study, sponsored by University of Virginia.
NCT04138017 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04138017 has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- 15 participants
- Enrollment target
Study 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.
Primary Outcome
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by \>50%. Results are for total number of joints fused which exceeds the number of participants due to some subjects having multiple joints fused.
Interventions
- DEVICE ViviGen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-10-23 |
| Est. Completion | 2023-12-01 |
What the finished NCT04138017 record still lists
NCT04138017 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which ViviGen is the first listed.
NCT04138017 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04138017 about?
NCT04138017 is a clinical study titled "ViviGen Cellular Bone Matrix for Hindfoot or Ankle Arthrodesis". 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.
What is the current status of trial NCT04138017?
This trial is currently completed. The enrollment target is 15 participants. The study started on 2018-10-23. Estimated completion is 2023-12-01.
What interventions are being tested in trial NCT04138017?
The interventions under investigation include: ViviGen (DEVICE).
Who is sponsoring clinical trial NCT04138017?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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