The spine journal : official journal of the North American Spine Society
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Randomized Controlled Trial Multicenter Study
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.
The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. ⋯ The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.
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Lumbar zygapophyseal joint (Z-joint) synovial cysts can cause low back pain (LBP), spinal stenosis, and lower extremity radiculopathy. In the literature, there are several minimally invasive techniques described with mixed results. Typical recommended treatment is surgical resection of the cyst. Currently, there is little information available concerning the efficacy and outcome with treatment of Z-joint synovial cyst by percutaneous, fluoroscopic, contrast-enhanced distention, and rupture. ⋯ Fluoroscopic percutaneous Z-joint cyst rupture appears to be a safe and effective minimally invasive treatment option. This procedure should be considered before surgical intervention.
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The use of nonsteroidal anti-inflammatory drugs (NSAIDs) had been implicated as a risk factor for nonunion in spinal fusion. Even with a number of animal and human studies suggesting NSAIDs either delay or inhibit spinal fusion rates, these drugs continue to be used because of demonstrated benefits. Diclofenac sodium is no exception. It is very popular as a first-line treatment for acute pain, even perioperatively for spine fusion patients. Review of published literature reveals no studies done on the effect of diclofenac sodium on spine fusion rates. ⋯ Diclofenac sodium showed a dose-dependent inhibitory effect toward spine fusion especially when used during the immediate postoperative period. No significant correlation was seen between age, sex, L5-S1 versus other levels fused and smoking history when compared with spine nonunion. Two-level lumbar fusions also showed a significant negative correlation to spine fusion compared with single-level fusions.
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Achieving solid implant fixation to osteoporotic bone presents a clinical challenge. New techniques and devices are being designed to increase screw-bone purchase of pedicle screws in the lumbar spine via a novel cortical bone trajectory that may improve holding screw strength and minimize loosening. Preliminary clinical evidence suggests that this new trajectory provides screw interference that is equivalent to the more traditionally directed trajectory for lumbar pedicle screws. However, a biomechanical study has not been performed to substantiate the early clinical results. ⋯ The current study demonstrated that the new cortical trajectory and screw design have equivalent pullout and toggle characteristics compared with the traditional trajectory pedicle screw, thus confirming preliminary clinical evidence. The 30% increase in failure load of the cortical trajectory screw in uniaxial pullout and its juxtaposition to higher quality bone justify its use in patients with poor trabecular bone quality.
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Hemangioblastomas in the central nervous system are highly vascular lesions, but have low risk of hemorrhage. In spinal lesions, there are a few rare cases of intramedullary hemorrhages associated with hemangioblastoma, and their prognoses were very severe. ⋯ We present this rare case, and emphasize hemangioblastoma as the differential diagnosis in hemorrhagic spinal lesion.