MedTrace Logo

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

NCT03733626 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-06-26

Study results available
· View outcomes & findings →

Summary

The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.

Conditions

  • Lumbar Spondylolisthesis
  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Lumbar Radiculopathy
  • Lumbar Spinal Stenosis
  • Lumbar 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.

Sponsors & Collaborators

  • DePuy Synthes

    collaborator INDUSTRY

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Jad G Khalil, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2024-06-25
Completion
2024-06-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03733626 on ClinicalTrials.gov