Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care A Multi-Center Prospective Registry and Retrospective Data Collection Study
Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care A Multi-Center Prospective Registry and Retrospective Data Collection Study
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Clinical Trial Information
Trial Contact: Krol, David; Williamson, Alice R; Rodriguez Saavedra, Carlis M; Simoni, Christine; Clouser, Nicolette E
Trial Phone: 321.527.7315 ; 321-842-9415 ; 321.841.3631 ; 321.841.7293 ; 321-843-5687
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IRB No: 20.021.03
Protocol Abbrev: VIVIGEN
Principal Investigator: Mohamed K. Shaath, MD
Age Group: Adult
Secondary Protocol No: CR-20-002
Therapies Involved: Surgery
ClinicalTrials.gov ID: 04299022
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Objective
The objective of Study CR-20-002 is 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.
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Key Eligibility
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.
