Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
Completed · Not applicable
Conditions studied: Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy, Lumbar Spinal Stenosis, Lumbar Disc Disease
In brief
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.
Key facts
- Study ID
- NCT03733626
- Run by
- Corewell Health East
- People needed
- 46
- Starts
- 2019-03-19
- Expected to finish
- 2024-06-25
- Last updated by the study team
- 2025-06-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- ≥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.
You may not qualify if…
- 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
Where it is running
- William Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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