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NCT04299022Recruiting

Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care

LifeNet Health

Start Date

6/1/2021

Completion Date

7/31/2026

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.

Detailed 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 Criteria

Age Range: No minimum to No maximum

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.

Interventions

OTHER

Vivigen Cellular Bone Matrix

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Conditions

Fractures, BoneNonunion of FractureFractures, OpenFractures, UnunitedFracture, TibialFracture of FemurFracture Arm

Locations

OrlandoHealth

Orlando, Florida 32806

United States

RWJBarnabas Health

Jersey City, New Jersey 07302

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

Sentara Hospitals

Norfolk, Virginia 23507

United States