Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Di… (NCT03733626) | Clinical Trial Compass
CompletedNot Applicable
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
United States46 participantsStarted 2019-03-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
✓. 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
What they're measuring
1
Incidence of Successful Lumbar Fusion Measured Radiographically