Fractures, BoneNonunion of FractureFractures, OpenFractures, UnunitedFracture, TibialFracture of FemurFracture Arm
Investigational drug(s) / intervention(s)
Vivigen Cellular Bone Matrix
Vivigen Cellular Bone Matrix: Allograft bone matrix
Study summary
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Prospective Cohort Inclusion Criteria:
* 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.
Retrospective Cohort Inclusion Criteria:
\- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.
Prospective Cohort Exclusion Criteria:
1. Patients unable to understand either an English or Spanish consent will be excluded.
2. Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
Primary outcome measure(s)
Reintervention Rate — 24 months the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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