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Cellular Matrix

ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System for Lumbar Spinal Stenosis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months postoperative

Awards & highlights

ViviGen Trial 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.Check my eligibility

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.See study design

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.

ViviGen Trial 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.

ViviGen Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of successful Lumbar Fusion measured radiographically

Secondary outcome measures

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

ViviGen 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 / 6Eligibility criteria met

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Who is running the clinical trial?

DePuy SynthesIndustry Sponsor

30 Previous Clinical Trials

4,878 Total Patients Enrolled

William Beaumont HospitalsLead Sponsor

149 Previous Clinical Trials

112,812 Total Patients Enrolled

Jad G Khalil, MDPrincipal InvestigatorWilliam Beaumont Hospitals

2 Previous Clinical Trials

63 Total Patients Enrolled

Media Library

ViviGen® Cellular Bone Matrix (Cellular Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT03733626 — N/A

Lumbar Spinal Stenosis Research Study Groups: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle Screw System, Local Bone Autograft with DePuy Synthes Spinal Pedicle Screw System

Lumbar Spinal Stenosis Clinical Trial 2023: ViviGen® Cellular Bone Matrix Highlights & Side Effects. Trial Name: NCT03733626 — N/A

ViviGen® Cellular Bone Matrix (Cellular Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03733626 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have elected to partake in this trial?

"Affirmative. The details featured on clinicaltrials.gov signpost to the fact this medical trial, which was first shared on March 19th 2019 is actively looking for participants. About 40 patients are being sought from one particular site."

Answered by AI

Are any new participants being recruited to this experiment?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial is currently enlisting subjects, having been initially posted on March 19th 2019 and lastly modified on November 10th 2022. 40 patients are being sought after at a single medical centre."

Answered by AI