46
Participants
Start Date
March 19, 2019
Primary Completion Date
June 25, 2024
Study Completion Date
June 25, 2024
ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system
ViviGen® is manufactured by LifeNet Health. ViviGen® Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 1271.10 and will be used with the FDA approved DePuy Synthes Spinal pedicle screw system for fusion.
Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
Patient's own bone harvested during spinal surgery will be used with the FDA approved DePuy Synthes spinal pedicle screw system to create the fusion.
William Beaumont Hospital, Royal Oak
Collaborators (1)
DePuy Synthes
INDUSTRY
William Beaumont Hospitals
OTHER