Actively Recruiting
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Led by LifeNet Health · Updated on 2025-04-02
250
Participants Needed
4
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
CONDITIONS
Official Title
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union, or fusion setting will be eligible for inclusion.
- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union, or fusion setting will be eligible for inclusion.
You will not qualify if you...
- Patients unable to understand either an English or Spanish consent will be excluded.
- Patients unable to consent secondary to dementia and/or other mental or psychiatric diagnoses will be excluded.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
OrlandoHealth
Orlando, Florida, United States, 32806
Actively Recruiting
2
RWJBarnabas Health
Jersey City, New Jersey, United States, 07302
Not Yet Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
4
Sentara Hospitals
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
B
Barry Saxton, P.A.-C.
CONTACT
A
Alyce Jones, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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