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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03733626
Recruitment Status : Active, not recruiting
First Posted : November 7, 2018
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
DePuy Synthes
Information provided by (Responsible Party):
Jad Khalil MD, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Lumbar Spondylolisthesis Degenerative Disc Disease Degenerative Spondylolisthesis Lumbar Radiculopathy Lumbar Spinal Stenosis Lumbar Disc Disease Combination Product: ViviGen® Cellular Bone Matrix Combination Product: Local Bone Autograft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: Single (Participant)
Masking Description: Participants will be blinded to the randomization group and which bone graft is used during surgery
Primary Purpose: Treatment
Official Title: Clinical Outcomes Associated With the Use of ViviGen® in Conjunction With Posterolateral Fusion for the Treatment of Lumbar Degenerative Disc Disease
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ViviGen® Cellular Bone Matrix
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
ViviGen® is manufactured by DePuy Synthes, Inc. (West Chester, Pennsylvania). ViviGen® Cellular Bone Matrix is comprised of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen® Cellular Bone Matrix 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 1271.3 and will be used with the DePuy Synthes pedicle screw system for fusion.

Placebo Comparator: Local Bone Autograft
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 Autograft
Patient's own bone harvested during spinal surgery will be used with the DePuy Synthes pedicle screw system to create the fusion.




Primary Outcome Measures :
  1. Incidence of successful Lumbar Fusion measured radiographically [ Time Frame: 12 months postoperative ]
    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


Secondary Outcome Measures :
  1. Visual Analog Scale for Pain [ Time Frame: 12 months postoperative ]
    Equal to or greater than a 2-point decrease in patient reported outcomes as measured by Visual Analog Scale for pain (0-10 point scale, 0 = no pain and 10 = severe amount of pain) from baseline to 12-months.

  2. Change in Oswestry Disability Index for Pain and Function [ Time Frame: 12 months postoperative ]
    Equal to or greater than 15-point decrease in patient reported outcomes as measured by Oswestry Disability Index (0-100 point scale, 0 = least amount of disability, 100 = most severe disability) from baseline to 12-months.

  3. Change in Short Form Health Survey-36 for Quality of Life [ Time Frame: 12 months postoperative ]
    Equal to or greater than 15-point increase in patient reported outcomes as measured by SF-36 (0-100 point scale, 0 = low favorable health state and 100 = most favorable health state) from baseline to 12-months.

  4. Neurological Deficit per Lumbar Spine Neurological Exam [ Time Frame: 12 months postoperative ]
    Count of participants with new or worsening neurological (lumbar motor and sensory) deficit as evaluated by lumbar spine neurological exam from baseline through 12 months.

  5. Count of participants with revision surgery by month 12 [ Time Frame: 12 months postoperative ]
    Count of participants with revision surgery by month 12

  6. Count of participants developing pseudoarthrosis by month 12 [ Time Frame: 12 months postoperative ]
    Count of participants developing pseudoarthrosis by month 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any prior lumbar fusion surgery
  2. Requires fusion of more than two levels
  3. 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
  4. BMI > 40
  5. Active systemic infection or infection at operative site
  6. History of an osteoporotic fracture and/or vertebral body fracture
  7. Is currently being treated with chemotherapy, radiation, immunosuppression or chronic steroid therapy
  8. History of osteoporosis, osteopenia, or osteomalacia that would contraindicate spinal surgery
  9. Psychological or physical condition in the opinion of the investigator that would interfere with subject self-assessments
  10. History of neurological condition in the opinion of the investigator that may affect lumbar function and pain assessments
  11. Subjects with a history of cancer must be disease free for at least 3 years
  12. Pregnant, or plans on becoming pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733626


Locations
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United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
DePuy Synthes
Investigators
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Principal Investigator: Jad G Khalil, MD William Beaumont Hospitals
Publications:
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.

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Responsible Party: Jad Khalil MD, Staff physician and Assistant Professor of Orthopaedic Surgery, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT03733626    
Other Study ID Numbers: 2018-158
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Spinal Stenosis
Spinal Diseases
Intervertebral Disc Degeneration
Spondylolisthesis
Radiculopathy
Bone Diseases
Musculoskeletal Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spondylolysis
Spondylosis