Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care
This trial is currently recruiting participants
3 locations available for registration
Brief 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
Age Range
Gender
Healthy Volunteers
Detailed Criteria
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.
Conditions
Interventions
Vivigen Cellular Bone Matrix
Allograft bone matrix
OTHERTrial Locations
3 locations currently accepting registrations. Choose a recruiting location below to register your interest.
OrlandoHealth
Orlando, Florida, United States
RWJBarnabas Health
Jersey City, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
Sentara Hospitals
Norfolk, Virginia, United States
Sponsor Information
Lead Sponsor
LifeNet Health
Type: INDUSTRY