Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
Start Date
6/1/2021
Completion Date
7/31/2026
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.
Detailed Description
The prospective registry study and retrospective data collection study is planned 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. Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Vivigen Cellular Bone Matrix
Conditions
Locations
OrlandoHealth
Orlando, Florida 32806
United States
RWJBarnabas Health
Jersey City, New Jersey 07302
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Sentara Hospitals
Norfolk, Virginia 23507
United States