Dataset Information

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.

SUBMITTER: Moojen WA

PROVIDER: S-EPMC3898636 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Moojen Wouter A WA Arts Mark P MP Jacobs Wilco C H WC van Zwet Erik W EW van den Akker-van Marle M Elske ME Koes Bart W BW Vleggeert-Lankamp Carmen L A M CL Peul Wilco C WC

BMJ (Clinical research ed.) 20131114

<h4>Objective</h4>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.<h4>Design</h4>Randomized controlled trial.<h4>Setting</h4>Five neurosurgical centers (including one academic and four secondary level care centers) in the Netherlands.<h4>Participants</h4>203 participants were referred to the Leiden-The Hague Spine Prognostic ...[more]

PMID: 24231273

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Project description:STUDY DESIGN: Systematic review using a modified network analysis. OBJECTIVES: To compare the effectiveness and morbidity of interspinous-device placement versus surgical decompression for the treatment of lumbar spinal stenosis. SUMMARY: Traditionally, the most effective treatment for degenerative lumbar spinal stenosis is through surgical decompression. Recently, interspinous devices have been used in lieu of standard laminectomy. METHODS: A review of the English-language literature was undertaken for articles published between 1970 and March 2010. Electronic databases and reference lists of key articles were searched to identify studies comparing surgical decompression with interspinous-device placement for the treatment of lumbar spinal stenosis. First, studies making the direct comparison (cohort or randomized trials) were searched. Second, randomized controlled trials (RCTs) comparing each treatment to conservative management were searched to allow for an indirect comparison through a modified network analysis approach. Comparison studies involving simultaneous decompression with placement of an interspinous device were not included. Studies that did not have a comparison group were not included since a treatment effect could not be calculated. Two independent reviewers assessed the strength of evidence using the GRADE criteria assessing quality, quantity, and consistency of results. The strengths of evidence for indirect comparisons were downgraded. Disagreements were resolved by consensus. RESULTS: We identified five studies meeting our inclusion criteria. No RCTs or cohort studies were identified that made the direct comparison of interspinous-device placement with surgical decompression. For the indirect comparison, three RCTs compared surgical decompression to conservative management and two RCTs compared interspinous-device placement to conservative management. There was low evidence supporting greater treatment effects for interspinous-device placement compared to decompression for disability and pain outcomes at 12 months. There was low evidence demonstrating little to no difference in treatment effects between the groups for walking distance and complication rates. CONCLUSION: The indirect treatment effect for disability and pain favors the interspinous device compared to decompression. The low evidence suggests that any further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate. No significant treatment effect differences were observed for postoperative walking distance improvement or complication rates; however, findings should be considered with caution because of indirect comparisons and short follow-up periods.

Project description:BackgroundThere is limited literature regarding radiological outcomes in the use of interlaminar devices as an adjunct to decompression compared to decompression alone (DA) for symptomatic lumbar spinal stenosis (LSS). This study aims to assess and compare 5-year radiological outcomes following spinal decompression and decompression with ILD (D + ILD).MethodsWe conducted a retrospective review of prospectively collected data of 94 patients who underwent spinal decompression with or without ILD insertion between 2007-2015. Patients with symptomatic LSS who met the study criteria were offered spinal decompression with or without ILD insertion. Those patients who accepted ILD insertion were placed in the D + ILD group (n=39); while those opting for DA, were placed in the DA group (n=55). Radiological indices were assessed preoperatively, immediate post-operative, 2 years and 5 years postoperatively.ResultsThere were a total of 94 patients with 55 in the DA group and 39 in the D + ILD group. In both groups, there was no significant change post-operatively in the sagittal balance parameters namely, the mean pelvic incidence, pelvic tilt, sacral slope and pelvic incidence minus lumbar lordosis (PI - LL) during the 5-year follow-up. Comparing between the groups, there was no significant difference in sagittal balance parameters. Comparing between DA versus D + ILD, there was no significant difference in overall lordosis, but the D + ILD had a significant reduction in sagittal angle (at the index level) of 2.3° compared to the DA group (P=0.01). In the control group, there was no significant difference in the anterior disc, posterior disc and foraminal height post-operatively. In the D + ILD group, there was a significant mean increase of 1.3 mm in anterior disc height, 1.8 mm in posterior disc height and 4.7 mm in foraminal height compared to the control group. In both groups, there was significant improvement in all clinical outcomes namely 36-item short form survey physical component summary (SF36 PCS), 36-item short form survey mental component summary (SF36 MCS) and visual analogue scale (VAS). Comparing the groups, there was significant improvement in the D + ILD group in SF36 MCS (P=0.01) but no difference in SF36 PCS or VAS. Reoperation rates were equivalent.ConclusionsOur study found that in the management of lumbar stenosis, the use of an ILD as an adjunct device compared to DA had significant improvement in anterior disc, posterior disc and foraminal height with expected focal kyphosis at the level of intervention without change in the lumbar lordosis and sagittal balance at 5 years.

Dataset Information

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

Objective

Design

Setting

Participants

Interventions

Main outcome measures

Results

Conclusions

Trial registration

Publications

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

Similar Datasets

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