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

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.

• Authors: Wouter A Moojen, Mark P Arts, Wilco C H Jacobs, Erik W van Zwet, M Elske van den Akker-van Marle, Bart W Koes, Carmen L A M Vleggeert-Lankamp, Wilco C Peul, Leiden-The Hague Spine Intervention Prognostic Study Group
• Journal: BMJ (Clinical research ed.) (BMJ) Vol. 347 Pg. f6415 (Nov 14 2013) ISSN: 1756-1833 [Electronic] England
• PMID: 24231273 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Topics

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