Interspinous Spacer Implant in Patients with Lumbar Spinal Stenosis: Preliminary Results of a Multicenter, Randomized, Controlled Trial

A prospective, randomized, controlled trial was conducted to compare clinical outcomes in patients treated with an investigational interspinous spacer (Superion) versus those treated with an FDA-approved spacer (X-STOP). One hundred sixty-six patients with moderate lumbar spinal stenosis (LSS) unresponsive to conservative care were treated randomly with the Superion (n = 80) or X-STOP (n = 86) interspinous spacer. Study subjects were followed through 6 months posttreatment. Zurich Claudication Questionnaire (ZCQ) symptom severity scores improved 30% with Superion and 25% with X-STOP (both P < 0.001). Similar changes were noted in ZCQ physical function with improvements of 32% with Superion and 27% with X-STOP (both P < 0.001). Mean ZCQ patient satisfaction score ranged from 1.7 to 2.0 in both groups at all follow-up visits. The proportion of subjects that achieved at least two of three ZCQ clinical success criteria at 6 months was 75% with Superion and 67% with X-STOP. Axial pain decreased from 55 ± 27 mm at pretreatment to 22 ± 26 mm at 6 months in the Superion group (P < 0.001) and from 54 ± 29 mm to 32 ± 31 mm with X-STOP (P < 0.001). Extremity pain decreased from 61 ± 26 mm at pretreatment to 18 ± 27 mm at 6 months in the Superion group (P < 0.001) and from 64 ± 26 mm to 22 ± 30 mm with X-STOP (P < 0.001). Back function improved from 38 ± 13% to 21 ± 19% with Superion (P < 0.001) and from 40 ± 13% to 25 ± 16% with X-STOP (P < 0.001). Preliminary results suggest that the Superion interspinous spacer and the X-STOP each effectively alleviate pain and improve back function in patients with moderate LSS who are unresponsive to conservative care

Kontra Horowitza: U korist prava na reparacije za ropstvo crncima

Horowitz rejects reparations for African Americans. We demonstrate that their heirs are entitled to the property illegitimately obtained by the slave owners. When we operate under the libertarian homesteading principle, the land should be redistributed back to the people who worked and tilled it first. That is, the black slaves. Horowitz’s claims against reparations serve as a poor refutation towards the reparations argument. African Americans are entitled to the “40 acres and a mule” that was promised, yet never fulfilled. We rely upon libertarian theory to clearly understand the case for reparations.Horowitz ne prihvaća pravo na reparacije za ropstvo Afroamerikancima. Mi pokazujemo da njihovi nasljednici imaju pravo na imovinu koju su nelegitimno stekli robovlasnici. Prema libertarijanskom načelu homesteadinga, zemlju treba preraspodijeliti unatrag, ljudima koji su je prvi i obrađivali, odnosno crnim robovima. Horowitzove tvrdnje protiv reparacija jedva da su pokušaj pobijanja argumenata u korist reparacija. Afroamerikanci imaju pravo na tih “40 jutara i mazgu”, kako je obećano, ali nikada ispunjeno. Oslanjamo se na libertarijansku teoriju kako bismo jasno razumjeli problem prava na reparacije

Facet-sparing lumbar decompression with a minimally invasive flexible MicroBlade Shaver® versus traditional decompression: quantitative radiographic assessment.

BackgroundLaminectomy/laminotomy and foraminotomy are well established surgical techniques for treatment of symptomatic lumbar spinal stenosis. However, these procedures have significant limitations, including limited access to lateral and foraminal compression and postoperative instability. The purpose of this cadaver study was to compare bone, ligament, and soft tissue morphology following lumbar decompression using a minimally invasive MicroBlade Shaver® instrument versus hemilaminotomy with foraminotomy (HL).MethodsThe iO-Flex® system utilizes a flexible over-the-wire MicroBlade Shaver instrument designed for facet-sparing, minimally invasive "inside-out" decompression of the lumbar spine. Unilateral decompression was performed at 36 levels in nine human cadaver specimens, six with age-appropriate degenerative changes and three with radiographically confirmed multilevel stenosis. The iO-Flex system was utilized on alternating sides from L2/3 to L5/S1, and HL was performed on the opposite side at each level by the same investigator. Spinal canal, facet joint, lateral recess, and foraminal morphology were assessed using computed tomography.ResultsSimilar increases in soft tissue canal area and decreases in ligamentum flavum area were noted in nondiseased specimens, although HL required removal of 83% more laminar area (P &lt; 0.01) and 95% more bone resection, including the pars interarticularis and facet joints (P &lt; 0.001), compared with the iO-Flex system. Similar increases in lateral recess diameter were noted in nondiseased specimens using each procedure. In stenotic specimens, the increase in lateral recess diameter was significantly (P = 0.02) greater following use of the iO-Flex system (43%) versus HL (7%). The iO-Flex system resulted in greater facet joint preservation in nondiseased and stenotic specimens. In stenotic specimens, the iO-Flex system resulted in a significantly greater increase in foraminal width compared with HL (24% versus 4%, P = 0.01), with facet joint preservation.ConclusionThe iO-Flex system resulted in significantly better decompression of the lateral recess and foraminal areas compared with HL, while preserving posterior spinal elements, including the facet joint

Clinical utility of ultrasound guidance for intra-articular knee injections: a review

Intra-articular corticosteroid and hyaluronic acid injections provide short-term symptom amelioration for arthritic conditions involving structural damage or degenerative changes in the knee. Conventional palpation-guided anatomical injections frequently result in inaccurate needle placement into extra-articular tissue and adjacent structures. The purpose of this review was to determine the effect of ultrasound guidance on the accuracy of needle placement, clinical outcomes, and cost-effectiveness in comparison with anatomical landmark-guided intra-articular large joint injections, with particular emphasis on the knee. A total of 13 relevant studies were identified; five studied the knee, seven studied the shoulder, one used both the knee and shoulder, and none studied the hip. Ultrasound was used in seven studies; the remaining studies utilized air arthrography, fluoroscopy, magnetic resonance arthrography, or magnetic resonance imaging. Across all studies (using all imaging modalities and all joints), needle placement accuracy ranged from 63% to 100% with ultrasound and from 39% to 100% with conventional anatomical guidance. Imaging guidance improved the accuracy of intra-articular injections of the knee (96.7% versus 81.0%, P < 0.001) and shoulder (97.3% versus 65.4%, P < 0.001). In particular, ultrasound guidance of knee injections resulted in better accuracy than anatomical guidance (95.8% versus 77.8%, P < 0.001), yielding an odds ratio of 6.4 (95% confidence interval 2.9–14). Ultrasound guidance notably improves injection accuracy in the target intra-articular joint space of large joints including the knee. The enhanced injection accuracy achieved with ultrasound needle guidance directly improves patient-reported clinical outcomes and cost-effectiveness

Percutaneous pedicle screw reduction and axial presacral lumbar interbody fusion for treatment of lumbosacral spondylolisthesis: A case series

<p>Abstract</p> <p>Introduction</p> <p>Traditional surgical management of lumbosacral spondylolisthesis is technically challenging and is associated with significant complications. The advent of minimally invasive surgical techniques offers patients treatment alternatives with lower operative morbidity risk. The combination of percutaneous pedicle screw reduction and an axial presacral approach for lumbosacral discectomy and fusion offers an alternative procedure for the surgical management of low-grade lumbosacral spondylolisthesis.</p> <p>Case presentation</p> <p>Three patients who had L5-S1 grade 2 spondylolisthesis and who presented with axial pain and lumbar radiculopathy were treated with a minimally invasive surgical technique. The patients-a 51-year-old woman and two men (ages 46 and 50)-were Caucasian. Under fluoroscopic guidance, spondylolisthesis was reduced with a percutaneous pedicle screw system, resulting in interspace distraction. Then, an axial presacral approach with the AxiaLIF System (TranS1, Inc., Wilmington, NC, USA) was used to perform the discectomy and anterior fixation. Once the axial rod was engaged in the L5 vertebral body, further distraction of the spinal interspace was made possible by partially loosening the pedicle screw caps, advancing the AxiaLIF rod to its final position in the vertebrae, and retightening the screw caps. The operative time ranged from 173 to 323 minutes, and blood loss was minimal (50 mL). Indirect foraminal decompression and adequate fixation were achieved in all cases. All patients were ambulatory after surgery and reported relief from pain and resolution of radicular symptoms. No perioperative complications were reported, and patients were discharged in two to three days. Fusion was demonstrated radiographically in all patients at one-year follow-up.</p> <p>Conclusions</p> <p>Percutaneous pedicle screw reduction combined with axial presacral lumbar interbody fusion offers a promising and minimally invasive alternative for the management of lumbosacral spondylolisthesis.</p

Utilization of CT scanning associated with complex spine surgery.

BackgroundDue to the risk associated with exposure to ionizing radiation, there is an urgent need to identify areas of CT scanning overutilization. While increased use of diagnostic spinal imaging has been documented, no previous research has estimated the magnitude of follow-up imaging used to evaluate the postoperative spine.MethodsThis retrospective cohort study quantifies the association between spinal surgery and CT utilization. An insurance database (Humana, Inc.) with ≈ 19 million enrollees was employed, representing 8 consecutive years (2007-2014). Surgical and imaging procedures were captured by anatomic-specific CPT codes. Complex surgeries included all cervical, thoracic and lumbar instrumented spine fusions. Simple surgeries included discectomy and laminectomy. Imaging was restricted to CT and MRI. Postoperative imaging frequency extended to 5-years post-surgery.ResultsThere were 140,660 complex spinal procedures and 39,943 discectomies and 49,889 laminectomies. MRI was the predominate preoperative imaging modality for all surgical procedures (median: 80%; range: 73-82%). Postoperatively, CT prevalence following complex procedures increased more than two-fold from 6 months (18%) to 5 years (≥40%), and patients having a postoperative CT averaged two scans. For simple procedures, the prevalence of postoperative CT scanning never exceeded 30%.ConclusionsCT scanning is used frequently for follow-up imaging evaluation following complex spine surgery. There is emerging evidence of an increased cancer risk due to ionizing radiation exposure with CT. In the setting of complex spine surgery, actions to mitigate this risk should be considered and include reducing nonessential scans, using the lowest possible radiation dose protocols, exerting greater selectivity in monitoring the developing fusion construct, and adopting non-ferromagnetic implant biomaterials that facilitate MRI postoperatively

Hybrid Biosynthetic Autograft Extender for Use in Posterior Lumbar Interbody Fusion: Safety and Clinical Effectiveness

Autologous iliac crest bone graft is the preferred option for spinal fusion, but the morbidity associated with bone harvest and the need for graft augmentation in more demanding cases necessitates combining local bone with bone substitutes. The purpose of this study was to document the clinical effectiveness and safety of a novel hybrid biosynthetic scaffold material consisting of poly(D,L-lactide-co-glycolide) (PLGA, 75:25) combined by lyophilization with unmodified high molecular weight hyaluronic acid (10-12% wt:wt) as an extender for a broad range of spinal fusion procedures. We retrospectively evaluated all patients undergoing single- and multi-level posterior lumbar interbody fusion at an academic medical center over a 3-year period. A total of 108 patients underwent 109 procedures (245 individual vertebral levels). Patient-related outcomes included pain measured on a Visual Analog Scale. Radiographic outcomes were assessed at 6 weeks, 3-6 months, and 1 year postoperatively. Radiographic fusion or progression of fusion was documented in 221 of 236 index levels (93.6%) at a mean (±SD) time to fusion of 10.2+4.1 months. Single and multi-level fusions were not associated with significantly different success rates. Mean pain scores (+SD) for all patients improved from 6.8+2.5 at baseline to 3.6+2.9 at approximately 12 months. Improvements in VAS were greatest in patients undergoing one- or two-level fusion, with patients undergoing multi-level fusion demonstrating lesser but still statistically significant improvements. Overall, stable fusion was observed in 64.8% of vertebral levels; partial fusion was demonstrated in 28.8% of vertebral levels. Only 15 of 236 levels (6.4%) were non-fused at final follow-up

Minimally invasive presacral approach for revision of an Axial Lumbar Interbody Fusion rod due to fall-related lumbosacral instability: a case report

<p>Abstract</p> <p>Introduction</p> <p>The purpose of this study was to describe procedural details of a minimally invasive presacral approach for revision of an L5-S1 Axial Lumbar Interbody Fusion rod.</p> <p>Case presentation</p> <p>A 70-year-old Caucasian man presented to our facility with marked thoracolumbar scoliosis, osteoarthritic changes characterized by high-grade osteophytes, and significant intervertebral disc collapse and calcification. Our patient required crutches during ambulation and reported intractable axial and radicular pain. Multi-level reconstruction of L1-4 was accomplished with extreme lateral interbody fusion, although focal lumbosacral symptoms persisted due to disc space collapse at L5-S1.</p> <p>Lumbosacral interbody distraction and stabilization was achieved four weeks later with the Axial Lumbar Interbody Fusion System (TranS1 Inc., Wilmington, NC, USA) and rod implantation via an axial presacral approach.</p> <p>Despite symptom resolution following this procedure, our patient suffered a fall six weeks postoperatively with direct sacral impaction resulting in symptom recurrence and loss of L5-S1 distraction. Following seven months of unsuccessful conservative care, a revision of the Axial Lumbar Interbody Fusion rod was performed that utilized the same presacral approach and used a larger diameter implant. Minimal adhesions were encountered upon presacral re-entry. A precise operative trajectory to the base of the previously implanted rod was achieved using fluoroscopic guidance. Surgical removal of the implant was successful with minimal bone resection required. A larger diameter Axial Lumbar Interbody Fusion rod was then implanted and joint distraction was re-established. The radicular symptoms resolved following revision surgery and our patient was ambulating without assistance on post-operative day one. No adverse events were reported.</p> <p>Conclusions</p> <p>The Axial Lumbar Interbody Fusion distraction rod may be revised and replaced with a larger diameter rod using the same presacral approach.</p

A New Obesity Model Reveals the Hypophagic Properties of PACAP Involve the Regulation of Homeostatic Feeding in the Ventromedial Hypothalamic Nucleus and Hedonic Feeding in the Nucleus Accumbens

Binge eating in humans is a complex disorder that often involves discrete, compulsive feeding sessions of highly palatable foods even in the absence of a deprivation state or hunger. Binging can be effectively modeled in rodents by providing subjects with limited access to a palatable food source (Western Diet; WD) as an adjunct to ad lib access to normal chow (Standard Chow; SC). Although this design recapitulates several fundamental characteristics observed in binge eating disorder, the binge eating observed in this paradigm is likely a product of both hedonic and homeostatic drives with the need to balance energy stores still present. To isolate these feeding drives, we have developed a novel feeding regimen that modifies the classic limited access binge model to effectively delineate and separate homeostatic feeding from motivational feeding. This is achieved by entraining male Sprague-Dawley rats to a restricted feeding schedule (two hours per day) of SC followed by a short 15 minute limited access meal of either SC or WD (Restrict Fed-Limited Access; RFLA). The RFLA paradigm allows for the examination of pituitary adenylate-cyclase activating polypeptide (PACAP) on palatable food consumption in a fully satiated subject. PACAP has previously been shown to suppress feeding behavior when injected into the hypothalamus. In the current study, PACAP injected into the ventromedial hypothalamic nuclei (VMN) suppressed the two hour homeostatic SC meal, but not the subsequent 15 minute limited access meal of WD. By contrast, PACAP bilaterally administered into the nucleus accumbens (NAc) produced the opposite effect with PACAP suppressing the consumption of WD but not SC. Thus, PACAP mediated signaling in the VMN appears to be involved in homeostatic regulation of energy stores, whereas PACAP signaling in the NAc regulates feeding driven by palatability or hedonic qualities