High failure rate of the interspinous distraction device (X-Stop) for the treatment of lumbar spinal stenosis caused by degenerative spondylolisthesis

Abstract

The X-Stop interspinous distraction device has shown to be an attractive alternative to conventional surgical procedures in the treatment of symptomatic degenerative lumbar spinal stenosis. However, the effectiveness of the X-Stop in symptomatic degenerative lumbar spinal stenosis caused by degenerative spondylolisthesis is not known. A cohort of 12 consecutive patients with symptomatic lumbar spinal stenosis caused by degenerative spondylolisthesis were treated with the X-Stop interspinous distraction device. All patients had low back pain, neurogenic claudication and radiculopathy. Pre-operative radiographs revealed an average slip of 19.6%. MRI of the lumbosacral spine showed a severe stenosis. In ten patients, the X-Stop was placed at the L4–5 level, whereas two patients were treated at both, L3–4 and L4–5 level. The mean follow-up was 30.3 months. In eight patients a complete relief of symptoms was observed post-operatively, whereas the remaining 4 patients experienced no relief of symptoms. Recurrence of pain, neurogenic claudication, and worsening of neurological symptoms was observed in three patients within 24 months. Post-operative radiographs and MRI did not show any changes in the percentage of slip or spinal dimensions. Finally, secondary surgical treatment by decompression with posterolateral fusion was performed in seven patients (58%) within 24 months. In conclusion, the X-Stop interspinous distraction device showed an extremely high failure rate, defined as surgical re-intervention, after short term follow-up in patients with spinal stenosis caused by degenerative spondylolisthesis. We do not recommend the X-Stop for the treatment of spinal stenosis complicating degenerative spondylolisthesis.

Motion characteristics of the lumbar spinous processes with degenerative disc disease and degenerative spondylolisthesis

“…Because the role of the LSP in pathogenesis of low back pain remains unclear, the findings of our study may have valuable clinical implications. Recently, ISPD have been used as an alternative solution to the conventional decompressive surgery for DDD, lumbar spinal stenosis caused by degenerative lumbar spondylolisthesis (DLS) [27,28]. Promising clinical outcomes have been reported.…”

“…Promising clinical outcomes have been reported. However, there are also studies reporting that the interspinous implants may result in complications, including implant migration and spinous process fracture [4,27,28]. Kim et al [27,29] indicated that degenerative lumbar spondylolisthesis appears strongly associated with the occurrence of spinous process fracture after interspinous process spacer (IPS) surgery.…”

Market approval processes for new types of spinal devices: challenges and recommendations for improvement

“…Finally, the most recent RCT by Stromquist et al reported no statistically significant difference between decompressive surgery (50 patients) and implantation of the X-Stop Ò (50 patients) after 2-year follow-up [22]. However, they found a significantly higher re-operation rate compared to non-instrumented surgery, as was, among others, also reported by Verhoof in 2008 [29] and Deyo in 2013 [30].…”

Interspinous implants: are the new implants better than the last generation? A review

“…Mean surgery time for MID and X-STOP was 113 and 47 min, respectively. Reoperation rates due to recurrent symptoms were significantly higher for X-STOP than MID, however [11].…”