Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

March 19, 2019

Primary Completion Date

June 25, 2024

Study Completion Date

June 25, 2024

Conditions
Lumbar SpondylolisthesisDegenerative Disc DiseaseDegenerative SpondylolisthesisLumbar RadiculopathyLumbar Spinal StenosisLumbar Disc Disease
Interventions
COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

Trial Locations (1)

48073

William Beaumont Hospital, Royal Oak

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

DePuy Synthes

INDUSTRY

lead

William Beaumont Hospitals

OTHER

NCT03733626 - Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease | Biotech Hunter | Biotech Hunter