Journal of neurosurgery. Spine
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Randomized Controlled Trial Multicenter Study
Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site.
The authors report on a prospective randomized controlled multicenter trial in which they compared the clinical outcomes obtained in patients who underwent the placement of a Bryan Cervical Disc System with those obtained in patients who underwent anterior cervical discectomy and fusion (ACDF). In the present study, they evaluated the safety and effectiveness of the artificial disc based on data obtained at a single investigational site. ⋯ The preliminary results documented at this investigational site are encouraging. Evaluation of data acquired in the Bryan disc treatment group showed that improvements in the clinical parameters were similar to those in the fusion group. Additionally in the artificial disc-treated group, there was radiographic evidence that motion was maintained. It is theorized that motion preservation may potentially reduce the rate of adjacent-level cervical disc disease that has been documented in patients who undergo ACDF.
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Randomized Controlled Trial
Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy.
Recently, limited decompression procedures have been proposed in the treatment of lumbar stenosis. The authors undertook a prospective study to compare the safety and outcome of unilateral and bilateral laminotomy with laminectomy. ⋯ Bilateral and unilateral laminotomy allowed adequate and safe decompression of lumbar stenosis, resulted in a highly significant reduction of symptoms and disability, and improved health-related quality of life. Outcome after unilateral laminotomy was comparable with that after laminectomy. In most outcome parameters, bilateral laminotomy was associated with a significant benefit and thus constitutes a promising treatment alternative.
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Randomized Controlled Trial Clinical Trial
New treatment of lumbar disc herniation involving 5-hydroxytryptamine2A receptor inhibitor: a randomized controlled trial.
Serotonin or 5-hydroxytryptamine (5-HT) is a chemical mediator associated with nucleus pulposus-induced radiculopathy. Inhibition of 5-HT receptors may potentially alleviate symptoms in patients with lumbar disc herniation. This prospective randomized controlled study was performed to evaluate the efficacy of the 5-HT2A receptor inhibitor in the treatment of symptomatic lumbar disc herniation. ⋯ The current study provided evidence that the efficacy of the 5-HT2A inhibitor was comparable with that of NSAID therapy for lumbar disc herniation. The 5-HT2A inhibitor has the potential to alleviate symptoms in patients with lumbar disc herniation.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Neurological complications of lumbar artificial disc replacement and comparison of clinical results with those related to lumbar arthrodesis in the literature: results of a multicenter, prospective, randomized investigational device exemption study of Charité intervertebral disc. Invited submission from the Joint Section Meeting on Disorders of the Spine and Peripheral Nerves, March 2004.
Arthrodesis is the gold standard for surgical treatment of lumbar degenerative disc disease (DDD). Solid fusion, however, can cause stress and increased motion in the segments adjacent to the fused level. This may initiate and/or accelerate the adjacent-segment disease process. Artificial discs are designed to restore and maintain normal motion of the lumbar intervertebral segment. Restoring and maintaining normal motion of the segment reduces stresses and loads on adjacent level segments. A US Food and Drug Administration Investigational Device Exemptions multicentered study of the Charité artificial disc was completed. The control group consisted of individuals who underwent anterior lumbar interbody fusion involving BAK cages and iliac crest bone graft. This is the first report of Class I data in which a lumbar artificial disc is compared with lumbar fusion. ⋯ The Charité artificial disc is safe and effective for the treatment of single-level lumbar DDD, resulting in no higher incidence of neurological complications compared with BAK-assisted fusion and leading to equivalent or better outcomes compared with those obtained in the control group and those reported in the lumbar fusion literature.