Interspinous Spacer versus Traditional Decompressive Surgery for Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis

Abstract

BackgroundDynamic interspinous spacers, such as X-stop, Coflex, DIAM, and Aperius, are widely used for the treatment of lumbar spinal stenosis. However, controversy remains as to whether dynamic interspinous spacer use is superior to traditional decompressive surgery.MethodsMedline, Embase, Cochrane Library, and the Cochrane Controlled Trials Register were searched during August 2013. A track search was performed on February 27, 2014. Study was included in this review if it was: (1) a randomized controlled trial (RCT) or non-randomized prospective comparison study, (2) comparing the clinical outcomes for interspinous spacer use versus traditional decompressive surgery, (3) in a minimum of 30 patients, (4) with a follow-up duration of at least 12 months.ResultsTwo RCTs and three non-randomized prospective studies were included, with 204 patients in the interspinous spacer (IS) group and 217 patients in the traditional decompressive surgery (TDS) group. Pooled analysis showed no significant difference between the IS and TDS groups for low back pain (WMD: 1.2; 95% CI: −10.12, 12.53; P = 0.03; I2 = 66%), leg pain (WMD: 7.12; 95% CI: −3.88, 18.12; P = 0.02; I2 = 70%), ODI (WMD: 6.88; 95% CI: −14.92, 28.68; P = 0.03; I2 = 79%), RDQ (WMD: −1.30, 95% CI: −3.07, 0.47; P = 0.00; I2 = 0%), or complications (RR: 1.39; 95% CI: 0.61, 3.14; P = 0.23; I2 = 28%). The TDS group had a significantly lower incidence of reoperation (RR: 3.34; 95% CI: 1.77, 6.31; P = 0.60; I2 = 0%).ConclusionAlthough patients may obtain some benefits from interspinous spacers implanted through a minimally invasive technique, interspinous spacer use is associated with a higher incidence of reoperation and higher cost. The indications, risks, and benefits of using an interspinous process device should be carefully considered before surgery.

Superior outcomes of decompression with an interlaminar dynamic device versus decompression alone in patients with lumbar spinal stenosis and back pain: a cross registry study

“…Within the meta-analysis of Wu et al the pooled VAS back and leg pain relief comparing interspinous spacers versus decompression alone did not find any significant differences [28]. In three of these investigations, however, the devices were inserted without decompression: X-Stop Ò (Medtronic Inc., Minneapolis, MN) [29], Aperius Ò (Medtronic, Switzerland) [30], and coflex Ò without decompression [25].…”

“…The investigations of Richter et al [22] and Kumar et al [24] did not find significantly different complication and revision rates of coflex Ò as adjunct to decompression compared to decompression alone. In the Moojen investigation, the complication and reoperation rate was reported to be higher for additional coflex Ò implantation compared to decompression alone and the possible reason was mentioned before [25,28]. The low complication rate might lead to the assumption of a general underreporting of complications and reoperations within the unmonitored registries.…”

Perspective of Lumbar Segmental Instability for Surgical Evalua tion of Lumbar Disc Herniation

“…The meta -analyses showed no significant difference on clinical outcomes in comparison with decompressive surgery. Additionally ISD has higher incidence of long -term reoperation and might lead to burden of cost [20,21]. Furthermore biomechanical changes such as decrease in ROM, and increase of interdiscal pressure and facet load at the adjacent segment following implantation of ISD are reported in both finite element and in vitro biomechanical studies [22,23].…”

Interspinous implants: are the new implants better than the last generation? A review

“…Meta-analyses comparing standard decompression to IPDs have shown that IPDs are not as efficacious. Al-Min Wu et al conducted a retrospective study of IPD and laminectomy patients and found no significant difference between VAS and ODI improvements between the two groups but encountered a higher risk for reoperation in the IPD group during the 12-to 24-month follow-up period [28]. Patil et al compared IPD using X-STOP to laminectomy patients and found an increased risk of reoperation (12.6 vs. 5.8%, RR = 2.07) in the IPD cohort [29•].…”