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Cellular Matrix

Clinical Outcomes Associated with the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease (ViviGen Trial)

N/A

Waitlist Available

Led By Jad G Khalil, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requires decompression at intended fusion level (multi-level decompression allowed L1-S1)

≥18 years of age

Must not have

Any prior lumbar fusion surgery

Active systemic infection or infection at operative site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperative

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.

Who is the study for?

Adults over 18 who need lumbar fusion surgery for conditions like spinal stenosis or degenerative disc disease, and have not improved after at least 6 weeks of non-surgical treatment. Candidates should not be overweight (BMI >40), pregnant, have had previous lumbar fusions, cancer within the last 3 years, immune system issues due to treatments like chemotherapy or chronic steroid use, or any psychological/physical condition that could affect their participation.

What is being tested?

This study is testing if ViviGen® Cellular Bone Matrix can improve bone healing and patient outcomes compared to using one's own bone graft in spine surgery. Participants will either receive ViviGen with a DePuy Synthes Spinal Pedicle screw system or their own bone graft with the same screw system during a one- or two-level posterolateral lumbar fusion.

What are the potential side effects?

Potential side effects may include typical surgical risks such as pain at the graft site, infection risk at the operation area, inflammation around the screws used in surgery, and possible allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery to relieve pressure on my spine from L1 to S1.

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I am 18 years old or older.

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I have spinal stenosis, degenerative disc disease, or mild spondylolisthesis.

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I have significant back pain or sciatica, with a high disability score.

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I am having a specific spine surgery (L1-S1) with hardware.

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I have tried non-surgical treatments for over 6 weeks without improvement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery to fuse bones in my lower back.

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I currently have an infection in my body or at a surgery site.

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I need surgery to fuse more than two of my spine levels.

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I am currently undergoing chemotherapy, radiation, or taking immunosuppressants or steroids.

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I have a bone condition that prevents me from having spinal surgery.

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I have been cancer-free for at least 3 years.

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I have had a fracture due to weak bones.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of successful Lumbar Fusion measured radiographically

Secondary study objectives

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

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw SystemActive Control1 Intervention

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

Group II: Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw SystemPlacebo Group1 Intervention

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.

0 / 13Eligibility criteria met