Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis

Abstract

IntroductionDespite an increasing implantation rate of interspinous process distraction (IPD) devices in the treatment of intermittent neurogenic claudication (INC), definitive evidence on the clinical effectiveness of implants is lacking. The main objective of this review was to perform a meta-analysis of all systematic reviews, randomized clinical trials and prospective cohort series to quantify the effectiveness of IPDs and to evaluate the potential side-effects.MethodsData from all studies prospectively describing clinical results based on validated outcome scales and reporting complications of treatment of patients with INC with IPD placement. We searched MEDLINE, EMBASE, Web of Science, Cochrane (CENTRAL), CINAHL, Academic Search Premier, Science Direct up to July 2010. Studies describing patients with INC caused by lumbar stenosis, reporting complication rate and reporting based on validated outcome scores, were eligible. Studies with only instrumented IPD results were excluded.ResultsEleven studies eligible studies were identified. Two independently RCTs and eight prospective cohorts were available. In total 563 patients were treated with IPDs. All studies showed improvement in validated outcome scores after 6 weeks and 1 year. Pooled data based on the Zurich Claudication Questionnaire of the RCTs were more in favor of IPD treatment compared with conservative treatment (pooled estimate 23.2, SD 18.5–27.8). Statistical heterogeneity after pooled data was low (I-squared 0.0, p = 0.930). Overall complication rate was 7%.ConclusionAs the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced.

Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS® in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication

“…The incidence of device removal during this time was higher than in some other studies [14,15] but lower than in others [17,18]. In a recently published systematic review of the effectiveness of interspinous implant surgery in a total of 563 patients with NIC, 6 % of devices were found to have required replacement or reoperation [19]. Although it cannot be performed percutaneously, removal of the IPD is straightforward with minimal risk, and leaves other treatment options open (including open decompression surgery, with or without fusion), as fibrotic scar tissue in the spinal canal is not formed following the percutaneous approach.…”

Motion characteristics of the lumbar spinous processes with degenerative disc disease and degenerative spondylolisthesis

“…Recently, the LSP has attracted much attention as the sites for implantation of the interspinous process devices (ISPD) [1][2][3][4][5]. The minimally invasive surgery has been reported for the treatment of the patients with degenerative disc disease (DDD) [5] or symptomatic lumbar spinal stenosis caused by degenerative lumbar spondylolisthesis (DLS) [2].…”

Minimally invasive surgery for lumbar spinal stenosis

“…However, most of these studies did not compare the results with other interventions, and most did not have prospective study designs [17]. It took 30 years (from 1984 until 2013) until two prospective studies were published that compared IPD treatment with conventional (surgical) care [5,18,19].…”