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	<title>Neurosurgery Blog &#187; RCT</title>
	<atom:link href="http://www.neurosurgery-blog.com/archives/category/rct/feed" rel="self" type="application/rss+xml" />
	<link>http://www.neurosurgery-blog.com</link>
	<description>Daily bibliographic and video review of the Neurosurgery Department. La Fe University Hospital. Valencia, Spain</description>
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		<title>Assessment of adjacent-segment mobility after cervical disc replacement versus fusion: RCT with 1 year’s results</title>
		<link>http://www.neurosurgery-blog.com/archives/2805</link>
		<comments>http://www.neurosurgery-blog.com/archives/2805#comments</comments>
		<pubDate>Thu, 23 Jun 2011 22:00:07 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Randomized clinical trial]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Adjacent disc disease]]></category>
		<category><![CDATA[Arthroplasty]]></category>
		<category><![CDATA[motion]]></category>
		<category><![CDATA[RSA]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=2805</guid>
		<description><![CDATA[Eur Spine J (2011) 20:934–941. DOI 10.1007/s00586-010-1588-2
Disc prostheses have been designed to restore and maintain cervical segmental motion and reduce the accelerated degeneration of the adjacent level. There is no knowledge about the reaction of the neighboured asymptomatic segments after implantation of prostheses or fusion. The effects of these procedures to segmental movement of the [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2011/06/Assessment-of-adjacent-segment-mobility-after-cervical-disc.tiff"><img class="alignleft size-full wp-image-2806" title="Assessment of adjacent-segment mobility after cervical disc" src="http://www.neurosurgery-blog.com/wp-content/uploads/2011/06/Assessment-of-adjacent-segment-mobility-after-cervical-disc.tiff" alt="" width="195" height="186" /></a>Eur Spine J (2011) 20:934–941. DOI 10.1007/s00586-010-1588-2</strong></p>
<p style="text-align: justify;">Disc prostheses have been designed to restore and maintain cervical segmental motion and reduce the accelerated degeneration of the adjacent level. There is no knowledge about the reaction of the neighboured asymptomatic segments after implantation of prostheses or fusion. The effects of these procedures to segmental movement of the uninvolved vertebrae have not been subjected to studies so far.</p>
<p style="text-align: justify;">The objective of this study was to compare the segmental motion following cervical disc replacement versus fusion and the correlation to the clinical outcome. Another aim was to compare the segmental motion of the asymptomatic segments above the treated ones and to compare both with Roentgen stereometric analysis (RSA) including the asymptomatic segments.</p>
<p style="text-align: justify;">20 patients with one-level cervical radiculopathy scheduled for surgery were randomized to arthroplasty (10 patients, study group) or anterior cervical discectomy and fusion (10 patients, control group). Clinical results were evaluated using Visual Analogue Scale and Neck Disability Index. RSA was performed immediately postoperative, after 6 and 12 months.</p>
<p style="text-align: justify;">The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P&lt; 0.05). In the fusion group the segmental motion of the adjacent segment was significantly higher in all three dimensional axes (P&lt; 0.05) at each examination time. When the adjacent level of both groups is compared, the fusion group could show a higher segmental motion in all three-dimensional axes, but without significant difference (P&gt; 0.05) 1 year after surgery. Regarding the clinical results, there was no significant difference in pain relief between both groups (P&gt; 0.05).</p>
<p style="text-align: justify;">In conclusion, the adjacent segment could show a higher segmental motion, when compared with the segment either treated with prostheses or fusion. There was no significant difference in segmental motion adjacent to prosthesis or fusion. Clinical results did also show no significant difference in pain relief between both groups.</p>
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		<item>
		<title>Prospective, Randomized, Double-Blind Clinical Study Evaluating the Correlation of Clinical Outcomes and Cervical Sagittal Alignment</title>
		<link>http://www.neurosurgery-blog.com/archives/2656</link>
		<comments>http://www.neurosurgery-blog.com/archives/2656#comments</comments>
		<pubDate>Thu, 19 May 2011 22:00:45 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[RCT]]></category>
		<category><![CDATA[Randomized clinical trial]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Anterior cervical diskectomy and fusion]]></category>
		<category><![CDATA[cervical sagittal alignment]]></category>
		<category><![CDATA[Clinical outcomes]]></category>
		<category><![CDATA[Prospective clinical study]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=2656</guid>
		<description><![CDATA[Neurosurgery 68:1309–1316, 2011. DOI:10.1227/NEU.0b013e31820b51f3
Sagittal alignment of the cervical spine has received increased attention in the literature as an important determinant of clinical outcomes after anterior cervical diskectomy and fusion. Surgeons use parallel or lordotically fashioned grafts depending on preference or simple availability.
OBJECTIVE: To quantitatively assess and compare cervical sagittal alignment and clinical outcome when lordotic [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2011/05/cervical-sagital-aligment.jpg"><img class="alignleft size-thumbnail wp-image-2659" title="cervical sagital aligment" src="http://www.neurosurgery-blog.com/wp-content/uploads/2011/05/cervical-sagital-aligment-150x150.jpg" alt="" width="150" height="150" /></a>Neurosurgery 68:1309–1316, 2011. DOI:10.1227/NEU.0b013e31820b51f3</strong></p>
<p style="text-align: justify;">Sagittal alignment of the cervical spine has received increased attention in the literature as an important determinant of clinical outcomes after anterior cervical diskectomy and fusion. Surgeons use parallel or lordotically fashioned grafts depending on preference or simple availability.</p>
<p style="text-align: justify;">OBJECTIVE: To quantitatively assess and compare cervical sagittal alignment and clinical outcome when lordotic or parallel allografts were used for fusion.</p>
<p style="text-align: justify;">METHODS: A prospective, randomized, double-blind clinical study that enrolled 122 patients was performed. The mean follow-up was 37.5 months (range, 12-54 months).</p>
<p style="text-align: justify;">RESULTS: The mean postoperative cervical sagittal alignment was 19 (range, 27-36) and 18 (range, 27-37) in the lordotic and parallel graft patient groups, respectively. The mean segmental sagittal alignment was 6 (range, 24-19) and 7 (range, 23-19) in the lordotic and parallel graft patient groups, respectively. There were no statistically significant differences in clinical outcome scores between the lordotic and parallel graft patient groups. However, patients who had maintained or improved segmental sagittal alignment, regardless of graft type, achieved a higher degree of improvement in Short Form-36 Physical Component Summary and Neck Disability Index scores. This was statistically significant (P , .038).</p>
<p style="text-align: justify;">CONCLUSION: The use of lordotically shaped allografts does not increase cervical/ segmental sagittal alignment or improve clinical outcomes. Maintaining a consistent segmental sagittal alignment or increasing segmental lordosis was related to a higher degree of improvement in clinical outcomes.</p>
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		<item>
		<title>Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial</title>
		<link>http://www.neurosurgery-blog.com/archives/1577</link>
		<comments>http://www.neurosurgery-blog.com/archives/1577#comments</comments>
		<pubDate>Mon, 27 Sep 2010 04:00:06 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Randomized clinical trial]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Atrophy]]></category>
		<category><![CDATA[Creatine phosphokinase]]></category>
		<category><![CDATA[herniated disc]]></category>
		<category><![CDATA[Low back pain]]></category>
		<category><![CDATA[Microdiscectomy]]></category>
		<category><![CDATA[Muscle injury]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=1577</guid>
		<description><![CDATA[Eur Spine J. DOI 10.1007/s00586-010-1482-y
The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury.
We present the results of a double-blind randomized trial [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/MIN.jpg"><img class="alignleft size-thumbnail wp-image-1582" title="MIN" src="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/MIN-150x150.jpg" alt="" width="120" height="120" /></a>Eur Spine J. DOI 10.1007/s00586-010-1482-y</strong></p>
<p style="text-align: justify;">The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury.</p>
<p style="text-align: justify;">We present the results of a double-blind randomized trial on patients with lumbar disc herniation, in which tubular discectomy and conventional microdiscectomy were compared. In 216 patients, CPK was measured before surgery and at day 1 after surgery. In 140 patients, the CSA of the multifidus muscle was measured at the affected disc level before surgery and at 1 year after surgery. The ratios (i.e. post surgery/pre surgery) of CPK and CSA were used as outcome measures. The multifidus atrophy was classified into three grades ranging from 0 (normal) to 3 (severe atrophy), and the difference between post and pre surgery was used as an outcome. Patients’ low-back pain scores on the visual analogue scale (VAS) were documented before surgery and at various moments during follow-up.</p>
<p style="text-align: justify;">Tubular discectomy compared with conventional microdiscectomy resulted in a nonsignificant difference in CPK ratio, although the CSA ratio was significantly lower in tubular discectomy. At 1 year, there was no difference in atrophy grade between both groups nor in the percentage of patients showing an increased atrophy grade (14% tubular vs. 18% conventional). The postoperative low-back pain scores on the VAS improved in both groups, although the 1-year between-group mean difference of improvement was 3.5 mm (95% CI; 1.4–5.7 mm) in favour of conventional microdiscectomy.</p>
<p style="text-align: justify;">In conclusion, tubular discectomy compared with conventional microdiscectomy did not result in reduced muscle injury. Postoperative evaluation of CPK and the multifidus muscle showed similar results in both groups, although patients who underwent tubular discectomy reported more lowback pain during the first year after surgery.</p>
]]></content:encoded>
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		</item>
		<item>
		<title>A Comparative Analysis of the Results of Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Compression Fractures</title>
		<link>http://www.neurosurgery-blog.com/archives/1533</link>
		<comments>http://www.neurosurgery-blog.com/archives/1533#comments</comments>
		<pubDate>Thu, 16 Sep 2010 04:00:43 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Metabolic disorders]]></category>
		<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Surgical technique]]></category>
		<category><![CDATA[Kyphoplasty]]></category>
		<category><![CDATA[Osteoporosis]]></category>
		<category><![CDATA[Vertebral compression fractures]]></category>
		<category><![CDATA[vertebroplasty]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=1533</guid>
		<description><![CDATA[Neurosurgery 67[ONS Suppl 1]:ons171-ons188, 2010 DOI: 10.1227/01.NEU.0000380936.00143.11
The most common complication of osteoporosis is vertebral fractures, which occur more frequently than all other fractures (hip, wrist, and ankle).
OBJECTIVE: To prospectively analyze vertebroplasty compared with kyphoplasty for the treatment of osteoporotic vertebral compression fractures using improvement in pain, functional capacity, and quality of life as outcome measures.
METHODS: [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/vertebroplasty.jpg"><img class="alignleft size-thumbnail wp-image-1537" title="vertebroplasty" src="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/vertebroplasty-150x150.jpg" alt="" width="96" height="96" /></a>Neurosurgery 67[ONS Suppl 1]:ons171-ons188, 2010 DOI: 10.1227/01.NEU.0000380936.00143.11</strong></p>
<p style="text-align: justify;">The most common complication of osteoporosis is vertebral fractures, which occur more frequently than all other fractures (hip, wrist, and ankle).</p>
<p style="text-align: justify;">OBJECTIVE: To prospectively analyze vertebroplasty compared with kyphoplasty for the treatment of osteoporotic vertebral compression fractures using improvement in pain, functional capacity, and quality of life as outcome measures.</p>
<p style="text-align: justify;">METHODS: The study population included 28 patients in the vertebroplasty group and 24 patients in the kyphoplasty group. The mean follow-up period was 42.2 weeks and 42.3 weeks in the vertebroplasty and kyphoplasty groups, respectively. Outcomes were measured pre- and postoperatively using the visual analogue scale, the Oswestry Disability Index, the EuroQol-5D questionnaire, and the Short-Form 36 Health Survey.</p>
<p style="text-align: justify;">RESULTS: In the vertebroplasty group, visual analogue scale scores improved from a mean of 8.0 cm to 5.5 cm at last follow-up (P = .001). Preoperatively, the Oswestry Disability Index was 57.6, which improved to 38.4 (P = .006). The EuroQol-5D score preoperatively was 0.157 and improved to 0.504 (P = .001). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, role physical, body pain, and vitality. In the kyphoplasty group, visual analogue scale scores improved from a mean of 7.5 cm preoperatively to 2.5 cm postoperatively (P = .000001). The mean Oswestry Disability Index preoperatively was 50.7 and improved to 28.8 (P = .002). The EuroQol-5D score improved from a mean of 0.234 preoperatively to 0.749 (P = .00004). The Short-Form 36 Health Survey showed greatest improvement in the areas of physical health, physical functioning, role physical, body pain, and social functioning.</p>
<p style="text-align: justify;">CONCLUSION: Both vertebroplasty and kyphoplasty are effective at improving pain, functional disability, and quality of life; however, kyphoplasty provides better results, which are maintained over long-term follow-up.</p>
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		</item>
		<item>
		<title>Colloid Cysts of the Third Ventricle: Endoscopic Versus Microsurgical Removal</title>
		<link>http://www.neurosurgery-blog.com/archives/1521</link>
		<comments>http://www.neurosurgery-blog.com/archives/1521#comments</comments>
		<pubDate>Tue, 14 Sep 2010 04:00:22 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Surgical technique]]></category>
		<category><![CDATA[Colloid cyst]]></category>
		<category><![CDATA[Neuroendoscopy]]></category>
		<category><![CDATA[transcorticaltransventricular approach]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=1521</guid>
		<description><![CDATA[Neurosurg Q 2010;20:142–145
Study Design: A comparative randomized prospective clinical study.
Background and Purpose: The endoscopic approach to colloid cysts of the third ventricle is receiving increasing interest. However, its effectiveness is a matter of discussion. The aim of the study was to present a direct and long-term outcome after endoscopy of a colloid cyst versus microsurgery.
Materials [...]]]></description>
			<content:encoded><![CDATA[<p><strong><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/Colloidcyst.jpg"><img class="alignleft size-thumbnail wp-image-1524" title="Colloidcyst" src="http://www.neurosurgery-blog.com/wp-content/uploads/2010/09/Colloidcyst-150x150.jpg" alt="" width="120" height="120" /></a>Neurosurg Q 2010;20:142–145</strong></p>
<p style="text-align: justify;">Study Design: A comparative randomized prospective clinical study.</p>
<p style="text-align: justify;">Background and Purpose: The endoscopic approach to colloid cysts of the third ventricle is receiving increasing interest. However, its effectiveness is a matter of discussion. The aim of the study was to present a direct and long-term outcome after endoscopy of a colloid cyst versus microsurgery.</p>
<p style="text-align: justify;">Materials and Methods: Ten patients with colloid cysts were prospectively analyzed. Group A consisted of 5 patients treated endoscopically, whereas 5 patients treated using a transcorticaltransventricular approach comprised group B. Clinically, symptoms of raised intracranial pressure were predominant. All patients had hydrocephalus. Tumor diameter ranged from 10 to 27 mm. The mean follow-up period was 22 months.</p>
<p style="text-align: justify;">Results: The mean surgery time was 122 minutes in group A and 201 minutes in group B. Hospital stay was 1.5 days in the intensive care unit and 2.5 days in the ward in group A as compared with 3.5 days in the intensive care unit and 7 days in the ward in group B.</p>
<p style="text-align: justify;">Postoperative complications in group A were in the form of 1 transient hemiparesis and 1 transient short-term memory loss. Two patients in group B suffered transient short-term memory loss postoperatively and 1 patient suffered from transient hemiparesis. Clinically, the preoperative symptoms resolved in all the patients. One patient who underwent microsurgery required a ventriculoperitoneal shunt postoperatively. All patients who underwent endoscopy remained shunt independent.</p>
<p style="text-align: justify;">Conclusions: The endoscopic approach to colloid cysts of the third ventricle is safe, effective, and carries a low complication rate. Endoscopy may be recommended as a treatment option.</p>
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		<title>Early Rehabilitation Targeting Cognition, Behavior, and Motor Function After Lumbar Fusion A Randomized Controlled Trial</title>
		<link>http://www.neurosurgery-blog.com/archives/887</link>
		<comments>http://www.neurosurgery-blog.com/archives/887#comments</comments>
		<pubDate>Wed, 21 Apr 2010 04:00:10 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Uncategorized]]></category>
		<category><![CDATA[chronic low back pain]]></category>
		<category><![CDATA[cognitive-behavioural therapy]]></category>
		<category><![CDATA[exercise therapy]]></category>
		<category><![CDATA[motor control]]></category>
		<category><![CDATA[physiotherapy]]></category>
		<category><![CDATA[randomised controlled trial]]></category>
		<category><![CDATA[rehabilitation]]></category>
		<category><![CDATA[spinal fusion]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=887</guid>
		<description><![CDATA[Spine 2010;35:848–857
Study Design. Open label randomized controlled trial with 3-, 6-, 12-month, and 2- to 3-year follow-up.
Objective. To investigate the effectiveness of a psychomotor therapy focusing on cognition, behavior, and motor relearning compared with exercise therapy applied during the first 3 months after lumbar fusion.
Summary of Background Data. Postoperative management after lumbar fusion commonly focuses on [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">Spine 2010;35:848–857</p>
<p style="text-align: justify;">Study Design. Open label randomized controlled trial with 3-, 6-, 12-month, and 2- to 3-year follow-up.</p>
<p style="text-align: justify;">Objective. To investigate the effectiveness of a psychomotor therapy focusing on cognition, behavior, and motor relearning compared with exercise therapy applied during the first 3 months after lumbar fusion.</p>
<p style="text-align: justify;">Summary of Background Data. Postoperative management after lumbar fusion commonly focuses on analgesic pain control and activities of daily living. After 3 months, exercise therapy is often implemented. No randomized controlled trial has investigated early rehabilitation techniques conducted during the first 3 months after surgery.</p>
<p style="text-align: justify;">Methods. The study recruited 107 patients, aged 18 to 65 years, selected for lumbar fusion because of 12 months of symptomatic spinal stenosis, spondylosis, degenerative/isthmic spondylolisthesis, or degenerative disc disease. The exercise therapy group received a home program focusing on pain contingent training of back, abdominal, and leg muscle functional strength and endurance, stretching, and cardiovascular fitness. The psychomotor therapy group received a home program and 3 outpatient sessions focusing on modifying maladaptive pain cognitions, behaviors, and motor control. Rated questionnaires investigating functional disability, pain, health-related quality of life, functional self-efficacy, outcome expectancy, fear of movement/(re)injury, and coping were assessed at 3, 6, 12 months, and 2 to 3 years after surgery.</p>
<p style="text-align: justify;">Results. Follow-up rates were 93% at 12 months and 81% at 2 to 3 years after surgery. Psychomotor therapy improved functional disability, self-efficacy, outcome expectancy, and fear of movement/(re)injury significantly more than exercise therapy at respective follow-up occasions. Similar results occurred for pain coping but group differences were nonsignificant at 2 to 3 years follow-up. Potentially clinical relevant higher reoperation rates occurred after psychomotor therapy but rates were within normal ranges.</p>
<p style="text-align: justify;">Conclusion. The study shows that postoperative rehabilitation can be safely implemented during the first 3 months after lumbar fusion and should include measures to modify psychological as well as motor functions.</p>
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		<title>New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS)</title>
		<link>http://www.neurosurgery-blog.com/archives/783</link>
		<comments>http://www.neurosurgery-blog.com/archives/783#comments</comments>
		<pubDate>Mon, 29 Mar 2010 04:00:16 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Vascular]]></category>
		<category><![CDATA[complications]]></category>
		<category><![CDATA[carotid stenosis]]></category>
		<category><![CDATA[DWI]]></category>
		<category><![CDATA[endarterectomy]]></category>
		<category><![CDATA[ischaemic brain injury]]></category>
		<category><![CDATA[MRI]]></category>
		<category><![CDATA[stenting]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/archives/783</guid>
		<description><![CDATA[Lancet Neurol 2010; 9: 353–62. DOI:10.1016/S1474- 4422(10)70057-0

The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups.
Methods: Patients with recently symptomatic [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;"><a href="http://www.neurosurgery-blog.com/wp-content/uploads/2010/03/DWI-lesions.jpg"><img class="alignleft size-medium wp-image-784" title="DWI lesions" src="http://www.neurosurgery-blog.com/wp-content/uploads/2010/03/DWI-lesions-300x295.jpg" alt="" width="126" height="124" /></a>Lancet Neurol 2010; 9: 353–62. DOI:10.1016/S1474- 4422(10)70057-0</p>
<p style="text-align: justify;">
<p style="text-align: justify;">The International Carotid Stenting Study (ICSS) of stenting and endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups.</p>
<p style="text-align: justify;"><strong>Methods</strong>: Patients with recently symptomatic carotid artery stenosis enrolled in ICSS were randomly assigned in a 1:1 ratio to receive carotid artery stenting or endarterectomy. Of 50 centres in ICSS, seven took part in the MRI substudy. The protocol specified that MRI was done 1–7 days before treatment, 1–3 days after treatment (post-treatment scan), and 27–33 days after treatment. Scans were analysed by two or three investigators who were masked to treatment. The primary endpoint was the presence of at least one new ischaemic brain lesion on diffusion-weighted imaging (DWI) on the post-treatment scan. Analysis was per protocol. This is a substudy of a registered trial, ISRCTN 25337470.</p>
<p style="text-align: justify;"><strong>Findings</strong>: 231 patients (124 in the stenting group and 107 in the endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5∙21, 95% CI 2∙78–9∙79; p&lt;0∙0001). At 1 month, there were changes on fluid-attenuated inversion recovery sequences in 28 (33%) of 86 patients in the stenting group and six (8%) of 75 in the endarterectomy group (adjusted OR 5·93, 95% CI 2·25–15·62; p=0·0003). In patients treated at a centre with a policy of using cerebral protection devices, 37 (73%) of 51 in the stenting group and eight (17%) of 46 in the endarterectomy group had at least one new DWI lesion on post-treatment scans (adjusted OR 12·20, 95% CI 4·53–32·84), whereas in those treated at a centre with a policy of unprotected stenting, 25 (34%) of 73 patients in the stenting group and ten (16%) of 61 in the endarterectomy group had new lesions on DWI (adjusted OR 2·70, 1·16–6·24; interaction p=0·019).</p>
<p style="text-align: justify;"><strong>Interpretation:</strong> About three times more patients in the stenting group than in the endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions.</p>
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		<title>Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage</title>
		<link>http://www.neurosurgery-blog.com/archives/704</link>
		<comments>http://www.neurosurgery-blog.com/archives/704#comments</comments>
		<pubDate>Wed, 10 Mar 2010 05:00:57 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Outcome]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Vascular]]></category>
		<category><![CDATA[inflammation]]></category>
		<category><![CDATA[methylprednisolone]]></category>
		<category><![CDATA[neuroprotection]]></category>
		<category><![CDATA[Subarachnoid hemorrhage]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=704</guid>
		<description><![CDATA[J Neurosurg 112:681–688, 2010. DOI: 10.3171/2009.4.JNS081377

The object of this study was to determine the efficacy of methylprednisolone in reducing symptomatic vasospasm and poor outcomes after subarachnoid hemorrhage (SAH).
Methods. Ninety-five patients with proven SAH were recruited into a double-blind, placebo-controlled, random- ized trial. Starting within 6 hours after angiographic diagnosis of aneurysm rupture, placebo or methylprednisolone, [...]]]></description>
			<content:encoded><![CDATA[<p style="text-align: justify;">J Neurosurg 112:681–688, 2010. DOI: 10.3171/2009.4.JNS081377</p>
<p style="text-align: justify;">
<p style="text-align: justify;">The object of this study was to determine the efficacy of methylprednisolone in reducing symptomatic vasospasm and poor outcomes after subarachnoid hemorrhage (SAH).</p>
<p style="text-align: justify;">Methods. Ninety-five patients with proven SAH were recruited into a double-blind, placebo-controlled, random- ized trial. Starting within 6 hours after angiographic diagnosis of aneurysm rupture, placebo or methylprednisolone, 16 mg/kg, was administered intravenously every day for 3 days to 46 and 49 patients, respectively. Deterioration, defined as development of a focal sign or decrease of more than 1 point on the Glasgow Coma Scale for more than 6 hours, was investigated by using clinical criteria and transcranial Doppler ultrasonography, cerebral angiography, or CT when appropriate. The end points were incidence of symptomatic vasospasm (delayed ischemic neurological deficits associated with angiographic arterial narrowing or accelerated flow on Doppler ultrasonography, or both) and outcome 1 year after entry into the study according to a simplified Rankin scale (Functional Outcome Scale [FOS]) in living patients and the Glasgow Outcome Scale in all patients included.</p>
<p style="text-align: justify;">Results. All episodes of deterioration and all living patients with a 1-year outcome were assessed by a review committee. In patients treated with methylprednisolone, the incidence of symptomatic vasospasm was 26.5% com- pared with 26.0% in those given placebo. Poor outcomes according to FOS were significantly reduced in the Meth- ylprednisolone Group at 1 year of follow-up; the risk difference was 19.3% (95% CI 0.5–37.9%). The outcome was poor in 15% (6/40) of patients in the Methylprednisolone Group versus 34% (13/38) in the Placebo Group.</p>
<p style="text-align: justify;">Conclusions. A safe and simple treatment with methylprednisolone did not reduce the incidence of symptomatic vasospasm but improved ability and functional outcome at 1 year after SAH.</p>
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		<title>Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone</title>
		<link>http://www.neurosurgery-blog.com/archives/506</link>
		<comments>http://www.neurosurgery-blog.com/archives/506#comments</comments>
		<pubDate>Fri, 08 Jan 2010 05:00:19 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[Pain]]></category>
		<category><![CDATA[RCT]]></category>
		<category><![CDATA[Spine]]></category>
		<category><![CDATA[Aceclofenac]]></category>
		<category><![CDATA[Aceclofenac-tizanidine]]></category>
		<category><![CDATA[Acute LBP]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=506</guid>
		<description><![CDATA[Eur Spine J (2009) 18:1836–1842DOI 10.1007/s00586-009-1019-4

Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established.
The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low [...]]]></description>
			<content:encoded><![CDATA[<p style="margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px Helvetica;">Eur Spine J (2009) 18:1836–1842DOI 10.1007/s00586-009-1019-4</p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; font: 12.0px Helvetica; min-height: 14.0px;">
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;">Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established.</p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;">The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain.</p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;">This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18–70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)–tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober’s test and lateral body bending test) and patient’s and investigator’s global efficacy assessment.</p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;">Aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P &lt; 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P &lt; 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac–tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated.</p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;">In this study, aceclofenac–tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.</p>
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		<title>Wound healing after craniotomy: a randomized trial comparing scalp clips to artery forceps for scalp hemostasis</title>
		<link>http://www.neurosurgery-blog.com/archives/420</link>
		<comments>http://www.neurosurgery-blog.com/archives/420#comments</comments>
		<pubDate>Tue, 15 Dec 2009 05:55:33 +0000</pubDate>
		<dc:creator>cba</dc:creator>
				<category><![CDATA[RCT]]></category>
		<category><![CDATA[Surgical technique]]></category>
		<category><![CDATA[artery forceps]]></category>
		<category><![CDATA[craniotomy]]></category>
		<category><![CDATA[scalp clip]]></category>
		<category><![CDATA[wound healing]]></category>

		<guid isPermaLink="false">http://www.neurosurgery-blog.com/?p=420</guid>
		<description><![CDATA[J Neurosurg 111:1175–1178, 2009.(DOI: 10.3171/2009.5.JNS081481)
 
Object. In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to local  ized microscopic tissue damage and subsequent delayed wound healing.
Methods. The trial consisted of 2 arms in [...]]]></description>
			<content:encoded><![CDATA[<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;"><span style="letter-spacing: 0.0px;">J Neurosurg 111:1175–1178, 2009.(DOI: 10.3171/2009.5.JNS081481)</span></p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica; min-height: 14.0px;"><span style="letter-spacing: 0.0px;"> </span></p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;"><span style="letter-spacing: 0.0px;">Object. In this prospective randomized clinical trial, investigators looked at wound healing after craniotomy. The hypothesis was that the self-closing plastic scalp clips used for hemostasis on the skin edge might lead to local  ized microscopic tissue damage and subsequent delayed wound healing.</span></p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;"><span style="letter-spacing: 0.0px;">Methods. The trial consisted of 2 arms in which different methods were used to secure scalp hemostasis: 1) the routinely­used­plastic­clips (Scalpfix,­Aesculap); and 2)­the older method of artery forceps placed on the galea. Participants were restricted to those &gt; 16 years of age undergoing craniotomies expected to last &gt; 2 hours. Repeat operations were not included. One hundred fifty patients were enrolled.­They were visited at 3 and 6 weeks postoperativel by an observer blinded to the method used, and the wounds were assessed for macroscopic epithelial closure, signs of­infection, and hair regrowth by using a predefined assessment scale.</span></p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;"><span style="letter-spacing: 0.0px;">Results.­The results showed no significant difference in wound healing between the 2 groups at either 3 weeks (OR 0.55, 95% CI 0.27–1.11; p = 0.09) or 6 weeks (OR 0.79, 95% CI 0.39–1.58; p = 0.50). The length of operation was found to be a significant factor affecting wound healing at 6 weeks (OR/hour 0.68,­95%­CI 0.51–0.92; p­=0.01)</span></p>
<p style="margin: 0.0px 0.0px 0.0px 0.0px; text-align: justify; font: 12.0px Helvetica;"><span style="letter-spacing: 0.0px;">Conclusions.­The use of Aesculap Scalpfix self-retaining plastic scalp clips on the skin edge during craniotomy surgery does not appear to affect wound healing significantly to the postoperative 6 week mark.</span></p>
<div style="text-align: justify;"><span style="font-family: Helvetica, 'Times New Roman', 'Bitstream Charter', Times, serif; font-size: small;"><span style="line-height: normal;"><br />
</span></span></div>
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