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.
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.
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.
Prospective data will be collected for up to 250 subjects across up to 7 academic medical centers that will receive Vivigen Cellular Bone Matrix for treatment of a fracture. Retrospective data will be collected for up to an additional 250 subjects that received a bone graft adjunct for treatment of a fracture.
Cohort
Prospective
Vivigen Cellular Bone Matrix
Other interventionAllograft bone matrix
Reintervention Rate
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Fusion Rate
Acute fracture, delayed union or nonunion rate as assessed with radiographs at 6 weeks, 3 months, 6 months, 12 months and 24 months
Patient Reported Outcome Measurement Information System (PROMIS) Scores
Patient reported outcome measures will be measured via PROMIS scoring tool (mental and physical). The PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). Thus a score of 60 is one standard deviation above the average referenced population.
Click on the lead sponsor to view all of their trials.
