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.
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.
Study Type
OBSERVATIONAL
Enrollment
250
Allograft bone matrix
OrlandoHealth
Orlando, Florida, United States
RECRUITINGRWJBarnabas Health
Jersey City, New Jersey, United States
NOT_YET_RECRUITINGDuke University Medical Center
Durham, North Carolina, United States
RECRUITINGSentara Hospitals
Norfolk, Virginia, United States
RECRUITINGReintervention Rate
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
Time frame: 24 months
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
Time frame: 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.
Time frame: 24 months
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