At a glance
ClinicalIndex Comparison RecordN/ACompleted· 15 enrolled
Drug / intervention
ViviGendevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
In Brief
An observational study evaluating ViviGen for Ankle Deformity and Ankle Arthritis. Completed, enrolled 15 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Deformity, Ankle Arthritis
CountriesUnited States
CollaboratorsDePuy Synthes
Timeline
N/ACompletedFinished
20192020202120222023202420252026
Enrollment StartOct 2018
First PostedOct 2019
Primary CompletionApr 2023
Study CompletionDec 2023
TodayJul 2026
First PostedOct 24, 2019
Enrollment StartOct 23, 2018
Primary CompletionApr 10, 2023
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 6.7 years ago
Interventions
ViviGendevice
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.