Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial.

OBJECTIVE

To assess whether interspinous process device implantation is more effective in the short term than conventional surgical decompression for patients with intermittent neurogenic claudication due to lumbar spinal stenosis.

DESIGN

Randomized controlled trial.

SETTING

Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.

PARTICIPANTS

203 participants were referred to the Leiden-The Hague Spine Prognostic Study Group between October 2008 and September 2011; 159 participants with intermittent neurogenic claudication due to lumbar spinal stenosis at one or two levels with an indication for surgery were randomized.

INTERVENTIONS: 80 participants received an interspinous process device and 79 participants underwent spinal bony decompression.

MAIN OUTCOME MEASURES: The primary outcome at short term (eight weeks) and long term (one year) follow-up was the Zurich Claudication Questionnaire score. Repeated measurements were made to compare outcomes over time.

RESULTS

At eight weeks, the success rate according to the Zurich Claudication Questionnaire for the interspinous process device group (63%, 95% confidence interval 51% to 73%) was not superior to that for standard bony decompression (72%, 60% to 81%). No differences in disability (Zurich Claudication Questionnaire; P=0.44) or other outcomes were observed between groups during the first year. The repeat surgery rate in the interspinous implant group was substantially higher (n=21; 29%) than that in the conventional group (n=6; 8%) in the early post-surgical period (P<0.001).

CONCLUSIONS

This double blinded study could not confirm the hypothesized short term advantage of interspinous process device over conventional "simple" decompression and even showed a fairly high reoperation rate after interspinous process device implantation.

TRIAL REGISTRATION: Dutch Trial Register NTR1307.