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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

  • Clinical Trial Information

    Trial Contact: Harriott, Paula; Krol, David

    Trial Phone: 321.841.3867 ; 321.843.5390

  • 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

  • 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.

  • 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.