Neurochirurgie
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Review Multicenter Study
French collaborative group series on giant intracranial aneurysms: Current management.
Giant intracranial aneurysms represent a major therapeutic challenge for each surgical team. The aim of our study was to extensively review the French contemporary experience in treating giant intracranial aneurysms in order to assess the current management. ⋯ The overall favorable outcome rate concerned 57% of patients at 6 months despite 53.8% of poor initial clinical status in cases of rupture. The predictive factors for favorable outcome were good clinical status, endovascular treatment and the absence of postoperative neurological deterioration. Endovascular treatment should be integrated into the therapeutic armenmatarium against giant cerebral aneurysms but the durability of exclusion should be taken into account during the multidisciplinary discussion by the neurovascular team.
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Randomized Controlled Trial Multicenter Study
Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).
Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. ⋯ FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption.
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Randomized Controlled Trial Multicenter Study
"MAST" prospective study: value of minimal access spine technologies technique for multicolumn spinal cord stimulation surgical lead implantation in the context of a French multicentre randomized controlled trial (ESTIMET study).
Spinal cord stimulation (SCS) has been demonstrated to be an effective treatment for postoperative persistent leg pain after spine surgery, but treatment of the back pain component remains much more difficult, as it comprises mixed neuropathic and mechanical pain mechanisms. Moreover, these patients could present damaged tissues at the site of SCS lead implantation as a result of previous spine surgery. It can therefore be logically assumed that minimizing the surgical invasiveness of SCS implantation would be beneficial for these patients. Several studies have demonstrated the value of Minimal Access Spine Technologies (MAST) in spine surgery, but only a few case reports have been published concerning the use of MAST techniques for SCS. Therefore, we were prompted to conduct a second ESTIMET ancillary study to prospectively analyse the potential impact and benefits of MAST technique during SCS lead implantation versus an open surgical approach. ⋯ This is a multicentre, comparative, ancillary study conducted in 61 patients among the 115 enrolled patients ESTIMET study. One arm comprises patients undergoing multicolumn lead implantation via a Conventional Open Approach (COA) and the other arm comprises patients implanted by a MAST approach. Patients will be followed for 12 months after lead implantation. The following data will be collected: elevation of muscle enzymes (serum CPK), scar size, blood loss, infection rate, operating time and global, leg, back and scar NPRS.
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One of the main consequences of chronic pain syndrome is major impairment of the quality of sleep. Chronic pain and insomnia are independently linked to significant reductions in quality of life and psychiatric morbidity. Recent studies have suggested the efficacy of spinal cord stimulation (SCS) for the treatment of the back pain component in failed back surgery syndrome (FBSS) patients using a multicolumn lead. The main aim of this pilot study is to assess the influence and potential benefits of SCS on sleep quality in refractory FBSS patients implanted with multicolumn SCS and enrolled in the French multicentre ESTIMET study. ⋯ This is a single-centre, comparative, exploratory, pilot study. Sixteen FBSS patients enrolled in the ESTIMET study and implanted with multicolumn SCS will be monitored for 6months after implantation. Sleep parameters will be recorded by polysomnography, Psychomotor Vigilance Test and Osler tests, actigraphy, sleepiness scales, and sleep quality testing. Sleep will be evaluated before (at the inclusion visit) and after SCS implantation (at the 6-month visit). Secondary objectives will also assess the impact of SCS lead programming (mono vs. multicolumn SCS) and the influence of position-adaptive stimulation at night on sleep quality.
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Multicenter Study
[Cost-benefit evaluation of spinal cord stimulation treatment for failed-back surgery syndrome patients].
Spinal cord stimulation is a well-known treatment of rigorously selected failed-back surgery syndrome patients. Efficacy levels over 50% of pain relief have been reported in long-term studies. The objective of this multicenter prospective evaluation was to analyze the cost to benefit ratio of spinal cord stimulation treatment for failed back surgery syndrome patients. ⋯ This study confirms a clear analgesic effect on neuropathic sciatalgia, and moderate attenuation of low-back pain. One particular interest of this study is the medico-economic prospective evaluation showing that the initial cost of the implanted device is compensated by a significant, early, and stable reduction in the cost of associated pain therapies.