- Department of Neurosurgery, University of Kansas Medical Center, Kansas City, USA
- Department of Mechanical Engineering, University of Kansas, Lawrence KS, USA
Paul M. Arnold
Department of Neurosurgery, University of Kansas Medical Center, Kansas City, USA
DOI:10.4103/2152-7806.154461Copyright: © 2015 Bohm PE. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
How to cite this article: Bohm PE, Anderson KK, Friis EA, Arnold PM. Grade 1 spondylolisthesis and interspinous device placement: removal in six patients and analysis of current data. Surg Neurol Int 02-Apr-2015;6:54
How to cite this URL: Bohm PE, Anderson KK, Friis EA, Arnold PM. Grade 1 spondylolisthesis and interspinous device placement: removal in six patients and analysis of current data. Surg Neurol Int 02-Apr-2015;6:54. Available from: http://sni.wpengine.com/surgicalint_articles/grade-1-spondylolisthesis-interspinous-device-placement-removal-six-patients-analysis-current-data/
Background:In the treatment of patients with Grade 1 spondylolisthesis, the use of interspinous devices has been controversial for nearly a decade. Several authors have suggested that Grade 1 spondylolisthesis be considered a contraindication for interspinous device placement.
Methods:We removed interspinous devices in six symptomatic Grade 1 spondylolisthesis patients and analyzed pertinent literature.
Results:All six patients reported an improvement in symptoms following device removal and subsequent instrumented fusion. One patient who had not been able to walk due to pain regained the ability to walk. Several articles were identified related to spondylolisthesis and interspinous devices.
Conclusions:Regarding patients receiving interspinous devices for symptomatic lumbar spinal stenosis, several high-quality studies have failed to demonstrate a statistical difference in outcomes between patients with or without Grade 1 spondylolisthesis. Nevertheless, surgeons should have a high degree of suspicion when considering use of interspinous devices in this patient population.
In recent years, interspinous devices such as interspinous process spacers (IPSs) have been shown to be effective in reducing symptoms of lumbar spinal stenosis (LSS) by providing constant distraction of spinous processes. Although decompressive laminectomy has been considered the gold standard for treating LSS, IPSs may alleviate symptoms by creating a local environment of spinal flexion via a minimally invasive surgical approach. The relationship between spinal decompression and IPSs has been evaluated recently in a meta-analysis and high-quality studies.[
We present a series of six patients who had Grade 1 spondylolisthesis at the time of interspinous device placement and continued to have symptoms of neurogenic intermittent claudication (NIC) after surgery, necessitating device removal and instrumented lumbar fusion.
After approval by our institutional review board, we used two methods to analyze the relationship between Grade 1 spondylolisthesis and interspinous device placement. First, we retrospectively reviewed the medical records of six patients who underwent interspinous device removal at our institution. Second, we conducted a literature search in PubMed to find articles written in English that contained data, conclusions, or commentary regarding the use of interspinous devices in the setting of spondylolisthesis. There were more than 200 articles found using the search criteria (“X-STOP device”), (“X-STOP” and spondylolisthesis), and (“interspinous spacer” and spondylolisthesis). All articles were screened for potential relevance to the research question. Information from pertinent studies was collected and analyzed, including study design, number of patients with Grade 1 spondylolisthesis, results, and the authors’ conclusions. No formal appraisal of collected studies was conducted.
Our series included six patients, all women, who were treated at our institution between 2009 and 2013. Mean age at time of interspinous device placement was 63 years (range 51-83 years), and mean time elapsed since interspinous device placement was 35.8 months (range 3-96 months). Mean age at presentation to our clinic was 66 years (range 52-84 years), and mean overall duration of symptoms was 6.3 years (range 2-13 years). Mean follow-up after device removal was 9.2 months (range 4-12 months).
Four patients had received X-STOP devices for symptoms of NIC due to LSS. The other two patients had received the Aspen® device (Lanx, Inc., Broomfield, CO) for the same symptoms following microdecompression with stabilization. All four X-STOP patients had the X-STOP device implanted at two levels (three at L3-4/L4-5, one at L4-5/L5-S1), and the two Aspen patients had the Aspen device implanted at only one level (L4-5 or L5-S1) [
Removal of the interspinous devices was performed because of persistent radicular lower back, buttock, and leg pain with movement on flexion-extension films, as well as lumbar stenosis, spondylosis, and/or spondylolisthesis. Decompression of the thecal sac and nerve roots was performed via foraminotomies, laminectomies, and/or discectomies. Removal of the device(s) was followed by instrumentation with arthrodesis using local bone graft, demineralized bone matrix, and/or crushed cancellous allograft. Mean operative time was 3.5 h (range 2 h 12 min to 4 h 30 min). Findings during surgery included dystrophic muscle, significant scar tissue (some adherent to the dura), significant stenosis, and hypertrophied ligament. In some cases, the device barely had purchase on the spinous processes. There were no intraoperative complications during device removal. One patient experienced a small area of skin breakdown without drainage that was treated with oral antibiotics. Another patient developed a postoperative hematoma at the surgery site, which was treated successfully with irrigation, debridement, and evacuation. At follow-up, all patients reported symptom improvement, with some patients reporting complete resolution of preoperative pain. The patient who could not walk prior to device removal due to pain could now walk without her walker. Follow-up imaging revealed stable alignment and intact instrumentation.
The relationship between spondylolisthesis and interspinous devices has been controversial for nearly a decade. Despite the number of interspinous devices currently available for use, there is a paucity of published results regarding their safety and efficacy in patients with LSS, let alone in patients with concomitant spondylolisthesis. Of the studies that have been published, the vast majority have involved the X-STOP device.
In 2005, the FDA approved the X-STOP for the treatment of NIC due to LSS.[
We sought to determine whether or not Grade 1 spondylolisthesis should be considered a contraindication for X-STOP placement. In our study, we report six cases of X-STOP device removal—all in patients who had Grade 1 spondylolisthesis at the time of device placement. The results of our study, in addition to the results of several other studies summarized in Tables
Generating conclusions based on case reports and small studies is difficult due to the lack of control groups, especially when technique and experience vary between surgeons and institutions.
The studies summarized in
Nevertheless, many surgeons have noted a disproportionate amount of complications requiring reoperation in patients with Grade 1 spondylolisthesis who have had the X-STOP implanted at a single or double level.[
Kim et al. reported a 52% rate of spinous process fractures in patients with Grade 1 spondylolisthesis compared with none in patients without spondylolisthesis.[
In conclusion, we report six patients who required interspinous device removal and subsequent surgical decompression, all of whom had Grade 1 spondylolisthesis at the time of device placement. Review of the literature revealed several high-quality studies that found no statistically significant difference in outcomes between patients with or without Grade 1 spondylolisthesis receiving the X-STOP implant. However, surgeons should have a high degree of suspicion of potential complications in patients with Grade 1 spondylolisthesis who received an interspinous device, as many technical aspects may not have been considered before and during placement.
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