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

NCT03733626 | Completed Results FDA Device

• 1 other identifier: 2018-158
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Successful Lumbar Fusion Measured Radiographically

  Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level

  12 months postoperative

Secondary Outcomes (6)

• Visual Analog Scale for Pain

  12 months postoperative

• Change in Oswestry Disability Index for Pain and Function

  12 months postoperative

• Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary

  12 months postoperative

• Neurological Deficit Per Lumbar Spine Neurological Exam

  12 months postoperative

• Count of Participants With Revision Surgery by Month 12

  12 months postoperative

Study Arms (2)

ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System

ACTIVE COMPARATOR

20 subjects undergoing one or two-level instrumented posterolateral lumbar fusion surgery using ViviGen Cellular Bone Matrix mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system

Combination Product: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system

Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System

PLACEBO COMPARATOR

20 subjects undergoing open, one or two-level posterolateral lumbar fusion surgery using local autograft mixed with cortical/cancellous allograft and DePuy Synthes pedicle screw system.

Combination Product: Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system

Interventions

ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system COMBINATION_PRODUCT

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.

Also known as: ViviGen® Cellular Bone Matrix

ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System

Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system COMBINATION_PRODUCT

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.

Also known as: Local Bone Autologous Bone Graft

Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Able to provide consent
• Is undergoing standard of care one or two-level instrumented posterolateral fusion at the level between L1-S1
• Has diagnosis of spinal stenosis, degenerative disc disease and/or up to Grade 1 spondylolisthesis
• Requires decompression at intended fusion level (multi-level decompression allowed L1-S1)
• Has failed 6-weeks or more of conservative, non-operative treatment
• Has back and/or radicular lumbar symptoms with ODI score of ≥ 30 preoperatively.

You may not qualify if:

• Any prior lumbar fusion surgery
• Requires fusion of more than two levels
• Requires an interbody fusion based on relevant diagnoses and factors (such as foraminal stenosis, degree of spondylolisthesis, spinal deformity, disc space collapse, and subject's age) as determined by investigator
• BMI \> 40
• Active systemic infection or infection at operative site
• History of an osteoporotic fracture and/or vertebral body fracture
• Is currently being treated with chemotherapy, radiation, immunosuppression or chronic steroid therapy
• History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery
• Psychological or physical condition in the opinion of the investigator that would interfere with subject self-assessments
• History of neurological condition in the opinion of the investigator that may affect lumbar function and pain assessments
• Subjects with a history of cancer must be disease free for at least 3 years
• Pregnant, or plans on becoming pregnant

Sponsors & Collaborators

• Corewell Health East: lead
• DePuy Synthes: collaborator

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (8)

• Boden SD. Overview of the biology of lumbar spine fusion and principles for selecting a bone graft substitute. Spine (Phila Pa 1976). 2002 Aug 15;27(16 Suppl 1):S26-31. doi: 10.1097/00007632-200208151-00007.

  PMID: 12205416 BACKGROUND

• Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.

  PMID: 19540168 BACKGROUND

• Betz RR. Limitations of autograft and allograft: new synthetic solutions. Orthopedics. 2002 May;25(5 Suppl):s561-70. doi: 10.3928/0147-7447-20020502-04.

  PMID: 12038843 BACKGROUND

• Gazdag AR, Lane JM, Glaser D, Forster RA. Alternatives to Autogenous Bone Graft: Efficacy and Indications. J Am Acad Orthop Surg. 1995 Jan;3(1):1-8. doi: 10.5435/00124635-199501000-00001.

  PMID: 10790647 BACKGROUND

• DeCoster TA, Gehlert RJ, Mikola EA, Pirela-Cruz MA. Management of posttraumatic segmental bone defects. J Am Acad Orthop Surg. 2004 Jan-Feb;12(1):28-38. doi: 10.5435/00124635-200401000-00005.

  PMID: 14753795 BACKGROUND

• DePuy Synthes. https://www.depuysynthes.com/hcp/spine/products/qs/vivigen-cellular-bone-matrix. Copyright DePuy Synthes 2014-2017. DePuy Synthes Biomaterials Division 1302 Wrights Lane East, West Chester, Pennsylvania 19380.

  BACKGROUND

• Vaccaro AR, Stubbs HA, Block JE. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Orthopedics. 2007 Jul;30(7):567-70. doi: 10.3928/01477447-20070701-06.

  PMID: 17672157 BACKGROUND

• Kang J, An H, Hilibrand A, Yoon ST, Kavanagh E, Boden S. Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions. Spine (Phila Pa 1976). 2012 May 20;37(12):1083-91. doi: 10.1097/BRS.0b013e31823ed817.

  PMID: 22076647 BACKGROUND

MeSH Terms

Conditions

Spondylolisthesis; Intervertebral Disc Degeneration; Radiculopathy; Spinal Stenosis; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Jad Khalil, MD
• Organization: William Beaumont Hospitals

jad.khalil@corewellhealth.org

(248) 663-1900

Study Officials

• Jad G Khalil, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the randomization group and which bone graft is used during surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician and Assistant Professor of Orthopaedic Surgery

Model Details: Subjects will be randomized to either: 1) treatment arm where the investigator will use an FDA approved/cleared DePuy Synthes spinal pedicle screw system with ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft or the 2) control arm where the investigator use the same DePuy Synthes spinal pedicle screw system with local autologous bone graft mixed with cortical/cancellous allograft. Randomization is 1:1

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 7, 2018
• Study Start: March 19, 2019
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)