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

BMJ. 2013 Nov 14;347:f6415. doi: 10.1136/bmj.f6415.

Abstract

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Decompression, Surgical / instrumentation
  • Decompression, Surgical / methods*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Intermittent Claudication / etiology
  • Intermittent Claudication / surgery*
  • Lumbar Vertebrae / surgery*
  • Male
  • Middle Aged
  • Netherlands
  • Prospective Studies
  • Prostheses and Implants
  • Spinal Stenosis / complications
  • Spinal Stenosis / surgery*
  • Surveys and Questionnaires
  • Treatment Outcome