N/A
N=44
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
Lumbar Spondylolisthesis · Degenerative Disc Disease · Degenerative Spondylolisthesis · Lumbar Radiculopathy · Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT03733626 ↗Enrolled (actual)
44
Serious AEs
2.8%
Results posted
Jun 2025
Primary outcome: Primary: Incidence of Successful Lumbar Fusion Measured Radiographically — 13; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system (Combination_product); Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Corewell Health East
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Successful Lumbar Fusion Measured Radiographically |
13; 11 | — |
| SECONDARY Visual Analog Scale for Pain |
13; 12 | — |
| SECONDARY Change in Oswestry Disability Index for Pain and Function |
13; 11 | — |
| SECONDARY Change in Short Form Health Survey-36 for Quality of Life: Physical Component Summary |
12; 9 | — |
| SECONDARY Neurological Deficit Per Lumbar Spine Neurological Exam |
2; 2 | — |
| SECONDARY Count of Participants With Revision Surgery by Month 12 |
0; 0 | — |
| SECONDARY Count of Participants Developing Pseudoarthrosis by Month 12 |
0; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- ≥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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03733626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.