NCT02814825

An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix

A Multi-Center, Prospective, Single-Arm Study of Patients Undergoing a Two or Three Level ACDF Using ViviGen Cellular Bone Matrix in Conjunction With Cervical Allograft Spacers and DePuy Synthes Spine Anterior Cervical Plate Systems

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: DePuy Spine · Industry
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market study is to collect data on ViviGen and how its use affects fusion rates in the cervical spine when used as additional grafting material to fill the cervical spacer. The patient population of interest is patients who have already elected to undergo a 2-3 level ACDF surgical procedure using ViviGen, per standard of care.

Conditions

• Cervical Spondylosis
• Degenerative Intervertebral Discs
• Herniated Disc

Interventions

Type	Name	Description
OTHER	ViviGen	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 127 1.3(d).

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-02-22
• Completion: 2021-04-15
• First posted: 2016-06-28
• Last updated: 2026-02-17