Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
LifeNet Health
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.
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
- Age range
- Not specified
- Sex
- All
- 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 dementi…
Interventions
- OtherVivigen Cellular Bone Matrix
Allograft bone matrix
Locations (4)
- OrlandoHealthOrlando, Florida
- RWJBarnabas HealthJersey City, New Jersey
- Duke University Medical CenterDurham, North Carolina
- Sentara HospitalsNorfolk, Virginia