LimiFlex Clinical Trial for the Treatment of Degenerative Spondylolisthesis With Spinal Stenosis

Inclusion criteria

• ✓. Lumbar degenerative spondylolisthesis (Grade I per Meyerding classification), at one level from L1 to S1, with radiographic confirmation using X-ray;
• ✓. Lumbar spinal stenosis requiring decompression at up to two contiguous levels from L1 to S1, inclusive of the level diagnosed with degenerative spondylolisthesis, and confirmed radiographically using CT or MRI;
• ✓. Neurogenic claudication or radiculopathy symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain as evidenced by patient history;
• ✓. Persistent symptoms despite at least 3 months of conservative treatment that may include but is not limited to physical therapy, medications, and/or epidural injections;
• ✓. A pre-operative Visual Analog Scale (VAS) leg pain score of ≥50 on a 100 mm scale;
• ✓. A pre-operative Oswestry Disability Index (ODI) score ≥35 points on a 100-point scale;
• ✓. Candidate for surgical decompression at a single level or two contiguous levels, with stabilization at only one level between L1-S1;
• ✓. Posterior element anatomy is appropriate for interspinous fixation including prediction of presence of spinous processes of segment to be instrumented following decompression (investigational AND control groups) and a prediction of \>50% of facet joints present following decompression (investigational group only);