X-STOP is the first interspinous process decompression device that was shown to be superior to nonoperative therapy in patients with neurogenic intermittent claudication secondary to spinal stenosis in the multicenter randomized study at 1 and 2 years. We present 4-year follow-up data on the X-STOP patients. Patient records were screened to identify potentially eligible subjects who underwent X-STOP implantation as part of the FDA clinical trial. The inclusion criteria for the trial were age of at least 50 years, leg, buttock, or groin pain with or without back pain relieved during flexion, being able to walk at least 50 feet and sit for at least 50 minutes. The exclusion criteria were fixed motor deficit, cauda equina syndrome, previous lumbar surgery or spondylolisthesis greater than grade I at the affected level. Eighteen X-STOP subjects participated in the study. The average follow-up was 51 months and the average age was 67 years. Twelve patients had the X-STOP implanted at either L3-4 or L4-5 levels. Six patients had the X-STOP implanted at both L3-4 and L4-5 levels. Six patients had a grade I spondylolisthesis. The mean preoperative Oswestry score was 45. The mean postoperative Oswestry score was 15. The mean improvement score was 29. Using a 15-point improvement from baseline Oswestry Disability Index score as a success criterion, 14 out of 18 patients (78%) had successful outcomes. Our results have demonstrated that the success rate in the X-STOP interspinous process decompression group was 78% at an average of 4.2 years postoperatively and are consistent with 2-year results reported by Zucherman et al previously and those reported by Lee et al. Our results suggest that intermediate-term outcomes of X-STOP surgery are stable over time as measured by the Oswestry Disability Index.

OBJECTIVEBilateral symptoms have been reported in 8%–35% of patients with sacroiliac (SI) joint dysfunction. Stabilization of a single SI joint may significantly alter the stresses on the contralateral SI joint. If the contralateral SI joint stresses are significantly increased, degeneration may occur; alternatively, if the stresses are significantly reduced, bilateral stabilization may be unnecessary for patients with bilateral symptoms. The biomechanical effects of 1) unilateral stabilization on the contralateral SI joint and 2) bilateral stabilization on both SI joints are currently unknown. The objectives of this study were to characterize bilateral SI joint range of motion (ROM) and evaluate and compare the biomechanical effects of unilateral and bilateral implant placement for SI joint fusion.METHODSA lumbopelvic model (L5–pelvis) was used to test the ROM of both SI joints in 8 cadavers. A single-leg stance setup was used to load the lumbar spine and measure the ROM of each SI joint in flexion-extension, lateral bending, and axial rotation. Both joints were tested 1) while intact, 2) after unilateral stabilization, and 3) after bilateral stabilization. Stabilization consisted of lateral transiliac placement of 3 triangular titanium plasma-sprayed (TPS) implants.RESULTSIntact testing showed that during single-leg stance the contralateral SI joint had less ROM in flexion-extension (27%), lateral bending (32%), and axial rotation (69%) than the loaded joint. Unilateral stabilization resulted in significant reduction of flexion-extension ROM (46%) on the treated side; no significant ROM changes were observed for the nontreated side. Bilateral stabilization resulted in significant reduction of flexion-extension ROM of the primary (45%) and secondary (75%) SI joints.CONCLUSIONSThis study demonstrated that during single-leg loading the ROMs for the stance (loaded) and swing (unloaded) SI joints are significantly different. Unilateral stabilization for SI joint dysfunction significantly reduces the ROM of the treated side, but does not significantly reduce the ROM of the nontreated contralateral SI joint. Bilateral stabilization is necessary to significantly reduce the ROM for both SI joints.

Pedicle subtraction osteotomy (PSO) is a powerful technique to correct flat back deformity in the lumbar spine. Because corrections as great as 30–40 degrees can be achieved with this technique, contouring of the fusion rods can be quite extreme in PSO constructs. Rod failure (Figure 1) during the late post-operative period (<1 year) has been reported clinically and is commonly associated with pseudoarthrosis. In fact, instrumentation failure following PSO occurs frequently enough that several studies have reported and investigated revision strategies.

Study Design:Cadaver study.Objective:To determine the bone density of lumbar vertebral anatomic subregions. Bone mineral density (BMD) is a major factor in osseous fixation construct strength. The standard region for implant fixation of the spine is the pedicle; however, other regions may be more viable options with higher bone quality.Methods:Using computed tomography images, the spine was digitally isolated by applying a filter for adult bone. The spine model was separated into 5 lumbar vertebrae, followed by segmentation of each vertebra into 7 regions and determination of average Hounsfield units (HU). HU was converted to BMD with calibration phantoms of known BMD.Results:Overall mean BMD in vertebral regions ranged from 172 to 393 mg/cm3 with the highest and lowest BMD in the lamina and vertebral body, respectively. Vertebral regions formed 3 distinct groups (P < .03). The vertebral body and transverse processes represent one group with significantly lower BMD than other regions. Spinous process, pedicles, and superior articular processes represent a second group with moderate BMD. Finally, inferior articular process (IAP) and lamina represent a third group with significantly higher BMD than other regions.Conclusions:Standard lumbar fusion currently uses the vertebral body and pedicles as primary locations for fixation despite their relatively low BMD. Utilization of posterior elements, especially the lamina and IAP, may be advantageous as a supplement to modern constructs or the primary site for fixation, possibly mitigating construct failures due to loosening or pullout.

Results suggest that in the setting of PSO, the fatigue life of posterior spinal fixation rods depends largely on the severity of the rod angle used to maintain the vertebral angle created by the PSO and is significantly lowered by rod contouring.

This first reported technique of posterior element vertebroplasty may increase the indications and success for patients with decreased BMD who seek an interspinous implant such as the X STOP. A possible role may exist in increasing the effectiveness of such devices. However, clinical trials have yet been performed. These results demonstrate that PMMA injection in the spinous processes is effective in increasing resistance to compressive forces in an X STOP model.

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Study Design Retrospective reliability and validity study. Objective To validate a recently translated Russian language version of the Oswestry Disability Index (R-ODI) using standardized methods detailed from previous validations in other languages. Methods We included all subjects who were seen in our spine surgery clinic, over the age of 18, and fluent in the Russian language. R-ODI was translated by six bilingual people and combined into a consensus version. R-ODI and visual analog scale (VAS) questionnaires for leg and back pain were distributed to subjects during both their initial and follow-up visits. Test validity, stability, and internal consistency were measured using standardized psychometric methods. Results Ninety-seven subjects participated in the study. No change in the meaning of the questions on R-ODI was noted with translation from English to Russian. There was a significant positive correlation between R-ODI and VAS scores for both the leg and back during both the initial and follow-up visits (p < 0.01 for all). The instrument was shown to have high internal consistency (Cronbach α = 0.82) and moderate test–retest stability (interclass correlation coefficient = 0.70). Conclusions The R-ODI is both valid and reliable for use among the Russian-speaking population in the United States.