ViviGen® Cellular Bone Matrix for Lumbar Spinal Stenosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lumbar Spinal Stenosis+5 MoreViviGen® Cellular Bone Matrix - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the success rates of two different types of surgery for treating a specific back problem. One type of surgery uses a special bone matrix mixed with allograft, while the other type of surgery uses autograft mixed with allograft. The trial will measure the success of the surgeries by looking at the rates of radiographic fusion and patient reported outcomes.

Eligible Conditions
  • Lumbar Spinal Stenosis
  • Degenerative Disc Disease
  • Degenerative Spondylolisthesis
  • Lumbar Radiculopathy
  • Lumbar Spondylolisthesis
  • Lumbar Disc Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 12 months postoperative

12 months postoperative
Change in Oswestry Disability Index for Pain and Function
Change in Short Form Health Survey-36 for Quality of Life
Count of participants developing pseudoarthrosis by month 12
Count of participants with revision surgery by month 12
Incidence of successful Lumbar Fusion measured radiographically
Neurological Deficit per Lumbar Spine Neurological Exam
Visual Analog Scale for Pain

Trial Safety

Trial Design

2 Treatment Groups

ViviGen® Cellular Bone Matrix
1 of 2
Local Bone Autograft
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: ViviGen® Cellular Bone Matrix · Has Placebo Group · N/A

Local Bone Autograft
CombinationProduct
PlaceboComparator Group · 1 Intervention: Local Bone Autograft · Intervention Types: CombinationProduct
ViviGen® Cellular Bone Matrix
CombinationProduct
ActiveComparator Group · 1 Intervention: ViviGen® Cellular Bone Matrix · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months postoperative

Who is running the clinical trial?

DePuy SynthesIndustry Sponsor
27 Previous Clinical Trials
4,691 Total Patients Enrolled
William Beaumont HospitalsLead Sponsor
141 Previous Clinical Trials
114,368 Total Patients Enrolled
Jad G Khalil, MDPrincipal InvestigatorWilliam Beaumont Hospitals
2 Previous Clinical Trials
65 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are at least 18 years old.
You have back and/or radicular lumbar symptoms with ODI score of ≥ 30 preoperatively.
References