The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Abstract. Background. Decompressive laminotomy is the standard surgical procedure in the treatment of patients with canal stenosis related intermittent neurogenic claudication. New techniques, such as interspinous process implants, claim a shorter hospital stay, less post-operative pain and equal long-term functional outcome. A comparative (cost-) effectiveness study has not been performed yet. This protocol describes the design of a randomized controlled trial (RCT) on (cost-) effectiveness of the use of interspinous process implants versus conventi

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

Item does not contain fulltextINTRODUCTION: Despite 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. METHODS: Data 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. RESULTS: Eleven 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%. CONCLUSION: As the evidence is relatively low and the costs are high, more thorough (cost-) effectiveness studies should be performed before worldwide implementation is introduced

Interspinous spacers in the treatment of degenerative lumbar spinal disease: our experience with DIAM and Aperius devices

Insertion of an interspinous devices has became a common procedure for the treatment of different clinical picture of degenerative spinal disease. We present our experience in 1,575 patients with the use of two different interspinous spacers: Device for Intervertebral Assisted Motion (DIAM) and Aperius PercLID system. From 2000 through 2008, 1,315 consecutive patients underwent DIAM implantation and 260 had an Aperius PercLID procedure. The main surgical indications included: degenerative disc disease (478 patients), canal and/or foraminal stenosis (347 patients), disc herniation (283 patients), black disc and facet syndrome (143) and topping-off (64 patients). 1,100 patients underwent a single level implant and 475 had a multiple level implant. Mean operating time was 35 min for DIAM and 7 min for Aperius. Complications were detected in 20 patients (10 cases of infections, 10 fractures of the posterior spinous processes). 40 patients were subsequently treated with posterior arthrodesis (n = 30) or total disc replacement (n = 10). Patient’s postoperative clinical status was rated according to the modified Macnab criteria: symptoms resolution or improvement was achieved in 1,505 patients; and unchanged or unsatisfactory results in 70. Both techniques are safe, simple and less technically demanding. These approaches appear to be an effective alternative in selected cases, although conventional posterior lumbar decompression and fusion still may be required

Effect of a novel interspinous implant on lumbar spinal range of motion

Interspinous devices have been introduced to provide a minimally invasive surgical alternative for patients with lumbar spinal stenosis or foraminal stenosis. Little is known however, of the effect of interspinous devices on intersegmental range of motion (ROM). The aim of this in vivo study was to investigate the effect of a novel minimally invasive interspinous implant, InSwing®, on sagittal plane ROM of the lumbar spine using an ovine model. Ten adolescent Merino lambs underwent a destabilization procedure at the L1–L2 level simulating a stenotic degenerative spondylolisthesis (as described in our earlier work; Spine 15:571–576, 1990). All animals were placed in a side-lying posture and lateral radiographs were taken in full flexion and extension of the trunk in a standardized manner. Radiographs were repeated following the insertion of an 8-mm InSwing® interspinous device at L1–L2, and again with the implant secured by means of a tension band tightened to 1 N/m around the L1 and L2 spinous processes. ROM was assessed in each of the three conditions and compared using Cobb’s method. A paired t-test compared ROM for each of the experimental conditions (P < 0.05). After instrumentation with the InSwing® interspinous implant, the mean total sagittal ROM (from full extension to full flexion) was reduced by 16% from 6.3° to 5.3 ± 2.7°. The addition of the tension band resulted in a 43% reduction in total sagittal ROM to 3.6 ± 1.9° which approached significance. When looking at flexion only, the addition of the interspinous implant without the tension band did not significantly reduce lumbar flexion, however, a statistically significant 15% reduction in lumbar flexion was observed with the addition of the tension band (P = 0.01). To our knowledge, this is the first in vivo study radiographically showing the advantage of using an interspinous device to stabilize the spine in flexion. These results are important findings particularly for patients with clinical symptoms related to instable degenerative spondylolisthesis