European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Randomized Controlled Trial Comparative Study Clinical Trial
Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients.
We performed a randomised controlled study to assess the accuracy of computer-assisted pedicle screw insertion versus conventional screw placement under clinical conditions. One hundred patients scheduled for posterior thoracolumbar or lumbosacral pedicle screw instrumentation were randomised into two groups, either for conventional pedicle screw placement or computer-assisted screw application using an optoelectronic navigation system. From the computer-assisted group, nine patients were excluded: one because of an inadequate preoperative computed tomography study, seven because of problems with the specific instruments or the computer system, and one because of an intraoperative anesthesiological complication. ⋯ Pedicle perforations of more than 4 mm were found in 1.4% (4/277) of the screw insertions in the conventional group, and none in the computer-assisted group. Complications not related to pedicle screws were two L5 nerve root lesions, one end plate fracture, one major intraoperative bleeding and one postoperative death in the conventional group, and one deep infection in the computer-assisted group. In conclusion, pedicular screws were inserted more accurately with image-guided computer navigation than with conventional methods.
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Randomized Controlled Trial Comparative Study Clinical Trial
Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation.
This single-blind randomised clinical trial compared osteopathic manipulative treatment with chemonucleolysis (used as a control of known efficacy) for symptomatic lumbar disc herniation. Forty patients with sciatica due to this diagnosis (confirmed by imaging) were treated either by chemonucleolysis or manipulation. Outcomes (leg pain, back pain and self-reported disability) were measured at 2 weeks, 6 weeks and 12 months. ⋯ Crude cost analysis suggested an overall financial advantage from manipulation. Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis, it can be considered as an option for the treatment of symptomatic lumbar disc herniation, at least in the absence of clear indications for surgery. Further study into the value of manipulation at a more acute stage is warranted.
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Randomized Controlled Trial Comparative Study Clinical Trial
The value of MR imaging in differentiating between hard and soft cervical disc disease: a comparison with intraoperative findings.
The aim of this study is to assess the accuracy of MRI alone in the differentiation of soft cervical disc protrusion from osteophytic compression in cervical disc disease. In a retrospective study, the MRI scans of 41 patients with cervical disc disease, who had previously undergone surgery, were presented to three independent observers, randomly on two different occasions, to identify the accuracy of the diagnosis of the presence of hard or soft disc or both as a cause of compression. The observers (two neurosurgeons and one neuroradiologist) were not involved with the treatment of the cases at any stage and were unaware of the surgical findings. ⋯ The sensitivity of diagnosis of a hard disc was high (87%) but specificity was low (44%), due to the overestimation of the presence of hard disc. There was a significantly higher incidence of hard disc in the elderly age group (76% over the fifth decade, P = 0.0073). It is concluded that MRI alone is not a very efficient diagnostic tool in distinguishing between hard and soft disc in the cervical disc disease.
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Randomized Controlled Trial Clinical Trial
Expanded polytetrafluoroethylene membrane for the prevention of peridural fibrosis after spinal surgery: a clinical study.
Peridural fibrosis developing after laminectomy may cause pain that can necessitate reoperation. Many materials have been used as a barrier to invasion of fibrous tissue into the vertebral canal, but the ideal material has not been found. Various studies in animals have achieved favourable results with an expanded polytetrafluoroethylene (ePTFE) membrane. ⋯ Significantly more seromas occurred in the ePTFE group (P = 0.0002). There were no infections or other complications in either group. The results showed that placement of an ePTFE spinal membrane over the laminectomy defect produced by lumbar spine surgery provided a physical barrier to invasion of fibrous tissue into the vertebral canal, and patients with the membrane had less postoperative radicular pain.
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Randomized Controlled Trial Clinical Trial
Conservative treatment in patients sick-listed for acute low-back pain: a prospective randomised study with 12 months' follow-up.
We evaluated three different conservative treatment methods for acute low-back pain patients in groups following a manual therapy programme, an intensive training programme, or a general practitioner programme, the latter serving as the control group. Patients aged 19-64 years on sick leave for low-back pain with or without sciatica were included in a prospective randomised study evaluating outcomes such as impairment, pain, functional disability, socio-economic disability and satisfaction with the treatment or explanations. Evaluation by unbiased observers was performed at 1, 3 and 12 months. ⋯ All three study groups showed rapid improvement. After 1 month a significant improvement was noted in all outcome values compared with the values on entry to the study. Within the limitations discussed in our study, it is concluded that (1) patients sick listed with acute low-back pain, with or without sciatica, will be significantly improved after 1 month regardless of conservative treatment programme; (2) they will be more satisfied with the treatment if they are referred to a manual treatment programme or a training treatment programme; (3) they will be more satisfied with the explanations of the acute low-back problem if they are referred to one of the above groups, especially the manual treatment group; (4) they will not show any other differences with respect to subjective and objective variables, either at short-term or at long-term follow-ups.