Clinical Trial TitleA concurrently controlled study of LimiFlex™ Paraspinous Tension Band in the treatment of lumbar degenerative spondylolisthesis with spinal stenosis.
Clinical Trial Protocol Description:
The LimiFlex™ Clinical Trial is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of decompression and stabilization with the Empirical Spine LimiFlex™ Paraspinous Tension Band compared to decompression and transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) for the treatment of lumbar degenerative spondylolisthesis (Grade I per Meyerding classification) with spinal stenosis. We are currently only enrolling patients for solely TLIF/PLF subject.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have lumbar degenerative spondylolisthesis (Grade I per Meyerding classification), at one level from L1 to S1, with radiographic confirmation using X-ray.
- Grade I spondylolisthesis per Meyerding classification includes up to 25% anterior translation of a vertebra relative to the superior endplate of the subjacent vertebra at the index level. A patient is considered to have spondylolisthesis with a minimum 10% anterolisthesis at the affected level in a lateral x-ray image.
- Have lumbar spinal stenosis, at the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI.
- At the index level, lumbar spinal stenosis is at least moderate lumbar canal stenosis, defined as more than 25% reduction of the cross-sectional area compared with the next adjacent normal level, with nerve root crowding compared with the normal level, as determined by the investigator on CT Scan or MRI.
- Have neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain as evidenced by patient history.
- Have persistent symptoms despite at least 6 months of conservative treatment that may include but is not limited to physical therapy, medications, and/or epidural injections.
You will be excluded from the study if any of the following criteria apply to you:
- Have a primary and predominate diagnosis of discogenic back pain.
- Have a primary and predominate diagnosis of facet-mediated back pain.
- Have back or non-radicular leg pain of unknown etiology.
- Have significant peripheral vascular disease causing vascular claudication
This is a partial list of inclusion and exclusion criteria.