Overview
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
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:
- Patients unable to understand either an English or Spanish consent will be excluded.
- Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.