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Clinical evaluation of a lumbar interspinous dynamic stabilization device (the Wallis system) with a 13-year mean follow-up

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Abstract

The authors determined current health status of patients who had been included in a long-term survivorship analysis of a lumbar dynamic stabilizer. Among 133 living patients, 107 (average age at surgery, 44.2 ± 9.9 years) completed health questionnaires. All patients had initially been scheduled for decompression and fusion for canal stenosis, herniated disc, or both. In 20 patients, the implant was removed, and fusion was performed. The other 87 still had the dynamic stabilizer. Satisfaction, Oswestry disability index, visual analog scales for back and leg pain, short-form (SF-36) quality-of-life physical composite score, physical function, and social function were significantly better (p ≤ 0.05) in the patients who still had the dynamic stabilization device. SF-36 scores of the fused subgroup were no worse than those reported elsewhere in patients who had primary pedicle-screw enhanced lumbar fusion. This anatomy-sparing device provided a good 13-year clinical outcome and obviated arthrodesis in 80% of patients.

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Authors and Affiliations

  1. Centre Aquitain du Dos, Clinique Saint Martin, Pessac, France

    Jacques Sénégas & Paolo Mangione

  2. Unité de Pathologie Rachidienne, Centre Hospitalier Pellegrin, 7eme étage, Place Amélie Raba Léon, 33076, Bordeaux Cedex, France

    Jean-Marc Vital & Vincent Pointillart

Authors
  1. Jacques Sénégas
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  2. Jean-Marc Vital
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  3. Vincent Pointillart
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  4. Paolo Mangione
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Corresponding author

Correspondence to Jean-Marc Vital.

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Comments

Luciano Mastronardi, Roma, Italy

This is a very interesting article on a large series of patients with various type of lumbar instabilities treated with the interspinous device Wallis. I think any spine surgeon would find the data analysis complete, the follow-up adequate, and the results promising.

Even if I am not completely convinced that the interspinous device Wallis, which I use time by time, can avoid a lumbar fusion in a very high percentage of cases, I think that the readers will enjoy this experience. A multicenter, randomized study comparing the results of standard fixation and interspinous techniques would be very useful for the future.

Hatem Sabry, Jack Jallo, Philadelphia, USA

The authors of this article have conducted a retrospective study aimed at evaluating the health status of the patients who underwent a lumbar dynamic stabilization procedure. This is a well-written article covering a relatively large number of patients treated with the Wallis dynamic stabilizer and with a long-term follow-up of 13 years.

The authors concluded that the patients had excellent clinical results in terms of pain, disability, and quality of life. The question that comes to mind of course after reading this article is how these patients would compare to others managed conservatively. The answer to this would ideally be provided by a randomized, controlled study.

Yet, we cannot ignore that this study brings to light an important, less invasive, and somewhat underestimated alternative to traditional decompression and fusion of the spinal canal.

Li-Yang Dai, Shanghai, China

Senegas et al. provided a relatively large series of patients treated with interspinous process spacers for degenerative disorders of the lumbar spine. Their results of long-term follow-up are interesting and show success in the patients with implants survived. This clinical report suggests that satisfactory long-term results could be achieved when these devices are applied in appropriately selected patients. I congratulate the authors on adding to our knowledge in lumbar spine surgery.

As the authors pointed out, this study might be limited in its retrospective nature. It is difficult to determine whether the improvement of the clinical symptoms is the result of decompression or dynamic stabilization, or both of them. Therefore, a randomized, controlled study should be required for comparing the results between interspinous device insertion and fusion, although the authors found that better clinical outcome was noted at follow-up in the patients who still had the dynamic stabilizer than the patients who received subsequent fusion.

Another limitation of this study might be the heterogeneity of enrolled patients with regard to surgical indications. As generally believed, the interspinous process spacers are indicated for the patients with neurogenic claudication resulting from lumbar spinal stenosis. Our previous study showed that the capacity of the spinal canal is influenced by flexion-extension motion of the lumbar spine with a significant increase from extension to flexion (1). The advantage of using interspinous process spacers may lie in the enlargement of the spinal canal and decrease in painful motion by restricting the extension or increasing the flexion of lumbar spine. So far, as we know, there are no studies showing that interspinous process spacer insertion would be more advantageous than simple discectomy in the treatment of disc herniation. In fact, recurrence of disc herniation after the use of interspinous process devices in the primary discectomy has been reported (2). Concern remains regarding the role of the interspinous process spacers in the treatment of disc herniation.

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1. Dai LY, Xu YK, Zhang WM, Zhou ZH (1989) The effect of flexion-extension motion of the lumbar spine on the capacity of the spinal canal: an experimental study. Spine 14:523–525

2. Floman Y, Millgram MA, Smorgick Y, Rand N, Ashkenazi E (2007) Failure of the Wallis interspinous implant to lower the incidence of recurrent lumbar disc herniations in patients undergoing primary disc excision. J Spinal Disord Tech 20:337–341

All index operations were performed in the Unité de Pathologie Rachidienne, Centre Hospitalier Pellegrin, Bordeaux.

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Sénégas, J., Vital, JM., Pointillart, V. et al. Clinical evaluation of a lumbar interspinous dynamic stabilization device (the Wallis system) with a 13-year mean follow-up. Neurosurg Rev 32, 335–342 (2009). https://doi.org/10.1007/s10143-009-0199-z

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  • DOI: https://doi.org/10.1007/s10143-009-0199-z

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