Category: RCT

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Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial

The Treatment of Brain Arteriovenous Malformations Study (TOBAS) is a pragmatic study that includes 2 randomized trials and registries of treated or conservatively managed patients. The authors report the results of the surgical registry.

METHODS TOBAS patients are managed according to an algorithm that combines clinical judgment and randomized allocation. For patients considered for curative treatment, clinicians selected from surgery, endovascular therapy, or radiation therapy as the primary curative method, and whether observation was a reasonable alternative. When surgery was selected and observation was deemed unreasonable, the patient was not included in the randomized controlled trial but placed in the surgical registry. The primary outcome of the trial was mRS score > 2 at 10 years (at last follow-up for the current report). Secondary outcomes include angiographic results, perioperative serious adverse events, and permanent treatment-related complications leading to mRS score > 2.

RESULTS From June 2014 to May 2021, 1010 patients were recruited at 30 TOBAS centers. Surgery was selected for 229/512 patients (44%) considered for curative treatment; 77 (34%) were included in the surgery versus observation randomized trial and 152 (66%) were placed in the surgical registry. Surgical registry patients had 124/152 (82%) ruptured and 28/152 (18%) unruptured arteriovenous malformations (AVMs), with the majority categorized as low-grade SpetzlerMartin grade I–II AVM (118/152 [78%]). Thirteen patients were excluded, leaving 139 patients for analysis. Embolization was performed prior to surgery in 78/139 (56%) patients. Surgical angiographic cure was obtained in 123/139 all-grade (89%, 95% CI 82%–93%) and 105/110 low-grade (95%, 95% CI 90%–98%) AVM patients. At the mean follow-up of 18.1 months, 16 patients (12%, 95% CI 7%–18%) had reached the primary safety outcome of mRS score > 2, including 11/16 who had a baseline mRS score ≥ 3 due to previous AVM rupture. Serious adverse events occurred in 29 patients (21%, 95% CI 15%–28%). Permanent treatment-related complications leading to mRS score > 2 occurred in 6/139 patients (4%, 95% CI 2%–9%), 5 (83%) of whom had complications due to preoperative embolization.

CONCLUSIONS The surgical treatment of brain AVMs in the TOBAS registry was curative in 88% of patients. The participation of more patients, surgeons, and centers in randomized trials is needed to definitively establish the role of surgery in the treatment of unruptured brain AVMs.

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Randomized controlled trials comparing surgery to non-operative management in neurosurgery: a systematic review

Acta Neurochirurgica (2019) 161:627–634

A randomized controlled trial (RCT) remains the pinnacle of clinical research design. However, RCTs in neurosurgery, especially those comparing surgery to non-operative treatment, are rare and their relevance and applicability have been questioned. This study set out to assess trial design and quality and identify their influence on outcomes in recent neurosurgical trials that compare surgery to non-operative treatment.

Methods From 2000 to 2017, PubMed and Embase databases and four trial registries were searched. RCTs were evaluated for study design, funding, adjustments to reported outcome measures, accrual of patients, and academic impact.

Results Eighty-two neurosurgical RCTs were identified, 40 in spine disorders, 19 neurovascular and neurotrauma, 11 functional neurosurgery, ten peripheral nerve, and two pituitary surgery. Eighty-four RCTs were registered, of which some are ongoing. Trial registration rate differed per subspecialty. Funding was mostly from non-industry institutions (58.5%), but 25.6% of RCTs did not report funding sources. 36.4% of RCTs did not report a difference between surgical and non-operative treatment, 3.7% favored non-operative management. Primary and secondary outcome measures were changed in 13.2% and 34.2% of RCTs respectively and varied by subspecialty. 41.9% of RCTs subtracted ≥ 10% of the anticipated accrual and 12.9% of RCTs added ≥ 10%. 7.3% of registered RCTs were terminated, mostly due to too slow recruitment. Subspecialty, registration, funding, masking, population size, and changing outcome measures were not significantly associated with a reported benefit of surgery. High Jadad scores (≥ 4) were negatively associated with a demonstration of surgical benefit (P < 0.05).

Conclusions Neurosurgical RCTs comparing surgical to non-operative treatment often find a benefit for surgical treatment. Changes to outcome measurements and anticipated accrual are common and funding sources are not always reported.

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Symptomatic Adjacent Level Disease Requiring Surgery: Analysis of 10-Year Results From a Prospective, Randomized, Clinical Trial Comparing Cervical Disc Arthroplasty to Anterior Cervical Fusion

Neurosurgery 84:347–354, 2019

Ten-year follow-up data from the US Food and Drug Administration investigational device exemption trial comparing BRYAN  Cervical Disc (Medtronic, Dublin, Ireland) arthroplasty to anterior cervical discectomy and fusion (ACDF) demonstrated that disc arthroplasty maintained range of motion and improvements in overall success and neck disability.

OBJECTIVE: To compare the 10-yr rates of symptomatic adjacent level disease requiring surgery (SALDRS).

METHODS: Prospective randomized trial data were analyzed comparing BRYANR  Cervical Disc arthroplasty to ACDF for single-level cervical disc disease with concordant radiculopathy or myelopathy with clinicoradiographic analysis at 10 yr. Secondarily, 84-mo data were pooled with PRESTIGE   Cervical Disc arthroplasty (Medtronic) study data to provide overall rates of SALDRS.

RESULTS: Significantly greater overall success was maintained at every postoperative interval with an overall success rate of 81.3% with BRYAN  disc and 66.3% with ACDF (P = .005) without loss of motion preservation (8.69◦ vs 0.60◦). Reoperation at adjacent levels up to the 120-mo visit was 9.7% in the arthroplasty group and 15.8% in the ACDF group (P = .146). The combined data from BRYAN and Prestige ST demonstrate that BRYAN  and Prestige disc groups had a lower rate of second surgeries at the adjacent levels, up to the 84-mo visit, compared to the combined ACDF groups (6.9% vs 11.7%; P = .023).

CONCLUSION: Compared with ACDF, fewer patients with the BRYAN  disc required surgery for symptomatic adjacent level degeneration, but this did not achieve statistical significance. Analysis of combined study data using Bryan and Prestige discs shows significant differences in SADLRS as early as 7 yr.

 

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A randomised controlled trial comparing autologous cranioplasty with custom-made titanium cranioplasty

Acta Neurochirurgica (2018) 160:885–891

Objective To compare the long-term outcomes of patients who had been randomly allocated to receive primary titanium cranioplasty or autologous bone graft following decompressive craniectomy.

Methods Sixty-four patients had been previously enrolled and randomised to receive either their own bone graft or a primary titanium cranioplasty. Functional and cosmetic outcomes had previously been assessed at 1-year following the cranioplasty procedure. Hospital records and the Picture Archiving communication system were reviewed to determine how many patients had cranioplasty failure or associated complications such as seizures beyond 1 year—with a minimum of 24-month follow-up.

Results Amongst the 31 patients in the titanium group (one patient had died), no patients had a partial or complete cranioplasty failure at 12 months follow-up and there had been no failures beyond 12 months. Amongst the 31 patients who had an autologous cranioplasty (one patient had died), 7 patients had complete resorption of the autologous bone such that it was adjudged a complete failure at 12-month follow-up. Five of these patients had had titanium augmentation and two patients declined further surgery. Both of these patients requested cranial augmentation for functional and cosmetic reasons subsequent to the 12-month follow-up. Another patient who had previously been noted to have moderate resorption at 12 months presented 1 year later with progressive bone flap resorption and also required subsequent augmentation for functional and cosmetic reasons. When follow-up was extended to a minimum of 24 months, use of titanium instead of autologous bone for primary cranioplasty resulted in a significant reduction in the number of patients who required rescue cranioplasty (0 vs 25%, 95% confidence interval [CI] 9.1–42.1%; p = 0.001). In addition, there were significantly less total hospital healthcare costs in those patients randomised to the titanium arm of the trial (difference = A$9999, 95%CI 2231–17,768; p = 0.015).

Conclusions Bone resorption continued to occur beyond 12 months after autologous cranioplasty; use of primary titanium cranioplasty after decompressive craniectomy reduced the number of reoperations needed and the associated long-term total hospital costs.

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Opening the Internal Hematoma Membrane Does Not Alter the Recurrence Rate of Chronic Subdural Hematomas: A Prospective Randomized Trial

Is systematic post-operative CT scan indicated after chronic subdural hematoma surgery?

WORLD NEUROSURGERY 92: 31-36, AUGUST 2016

Factors determining the recurrence of chronic subdural hematomas (CSDHs) are not clear. Whether opening the so-called internal hematoma membrane is useful has not been investigated.

OBJECTIVE: To investigate whether splitting the inner hematoma membrane influences the recurrence rate in patients undergoing burr-hole craniotomy for CSDH.

METHODS: Fifty-two awake patients undergoing surgery for 57 CSDHs were prospectively randomized to either partial opening of the inner hematoma membrane (group A) or not (group B) after enlarged burr-hole craniotomy and hematoma evacuation. Drainage was left in situ for several days postoperatively. Groups were comparable with regard to demographic, clinical, and imaging variables. Outcome was assessed after 3e6 weeks for the combined outcome variable of reoperation or residual hematoma of one third or more of the original hematoma thickness.

RESULTS: Fourteen patients underwent reoperation for clinical deterioration or residual hematoma during follow- up (n = 6 in group A, 21%; n = 8 in group B, 28 %) (P = 0.537). Residual hematoma of ≥ one third not requiring surgery was present in 7 patients in group A (25%) and 10 patients in group B (36%) (P = 0.383). The overall cumulative failure rate (reoperation or hematoma thickness ≥ one third) was 13/28 (46%) in group A and 18/28 in group B (P = 0.178; relative risk, 0.722 [95% confidence interval, 0.445-1.172]; absolute risk reduction -16% =95% confidence interval, -38% to 8%]).

CONCLUSIONS: Opening the internal hematoma membrane does not alter the rate of patients requiring revision surgery and the number of patients showing a marked residual hematoma 6 weeks after evacuation of a CSDH.

 

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Effects of methylene blue on postoperative low-back pain and functional outcomes after lumbar open discectomy: a triple-blind, randomized placebo-controlled trial

Surgical technique and effectiveness of microendoscopic discectomy for large uncontained lumbar disc herniations

J Neurosurg Spine 24:7–15, 2016

Despite advances in surgical and anesthesiology techniques, many patients continue to experience postoperative pain after lumbar disc operations. This study aims to investigate the effects of methylene blue (MB) on preventing postoperative low-back pain (LBP) with or without radicular pain and improving the quality of life (QOL) in patients undergoing lumbar open discectomy.

Methods This is a prospective, randomized, triple-blind, placebo-controlled clinical trial, which was conducted at Shiraz University of Medical Sciences between July 2011 to January 2012. Of a total of 130 patients, 115 were eligible for participation; 56 received 1 ml of MB solution at a concentration of 0.5% (MB group) and 59 received an equivalent volume of normal saline (control group). Primary outcomes were the control of LBP with or without radicular pain, which was evaluated preoperatively and at 24 hours and 3 months after surgery with the use of a visual analog scale (VAS), and the improvement of QOL, which was assessed preoperatively and 3 months postoperatively by means of the Persian translation of the Oswestry Disability Index questionnaire.

Results The mean VAS scores for LBP were significantly lower in the MB group compared with the control group at 24 hours (1.25 ± 0.97 vs 2.80 ± 0.69, p < 0.001) and 3 months (1.02 ± 1.29 vs 2.07 ± 1.10, p = 0.019) after treatment. The mean radicular pain scores decreased significantly in the 2 groups at 24 hours after surgery, but the mean radicular pain score was significantly lower in the MB-treated patients than the control group. However, the difference between radicular pain scores in the MB group (1 ± 1.1) and the control group (1.2 ± 1) was not statistically significant (p = 0.64). The reduction in LBP was greater in the MB group than the control group (8.11 ± 1.74 vs 6.07 ± 1.52, p = 0.023, CI 95% –1.37 to –0.10). The functional QOL improved significantly 3 months after the operation in both groups (p < 0.001). Moderate disability occurred more frequently in the control group than in the MB group (14.5% vs 7.7%, p = 0.004). No toxicity, adverse effects, or complications were found in the group of patients treated with MB injection.

Conclusions A single dose of MB (1 ml 0.5%) for coating the dura and surrounding tissues (facet and muscle) shows promising results in terms of safety, reduction of postoperative pain, and functional outcome compared with placebo.

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Lumbar Total Disc Replacement for Discogenic Low Back Pain

Lumbar Total Disc Replacement for Discogenic Low Back Pain

Spine 2015;40:1873–1881

A prospective, multicenter, randomized, controlled, investigational device exemption (IDE) noninferiority trial.

Objective. The aim of this study was to evaluate the comparative safety and effectiveness of lumbar total disc replacement (TDR) in the treatment of patients with symptomatic degenerative disc disease (DDD) who are unresponsive to nonsurgical therapy.

Summary of Background Data. Lumbar TDR has been used to alleviate discogenic pain and dysfunction while preserving segmental range of motion and restoring stability. There is a paucity of data available regarding the comparative performance of lumbar TDR.

Methods. Patients presenting with symptomatic single-level lumbar DDD who failed at least 6 months of nonsurgical management were randomly allocated (2:1) to treatment with an investigational TDR device (activL1, n=218) or FDA-approved control TDR devices (ProDisc-L or Charité, n=106). The hypothesis of this study was that a composite effectiveness outcome at 2 years in patients treated with activL would be noninferior (15% delta) to that in controls.

Results. The primary composite endpoint of this study was met, which demonstrated that the activL TDR was noninferior to control TDR (P<0.001). A protocol-defined analysis of the primary composite endpoint also confirmed that activL was superior to controls (P=0.02). Radiographic success was higher with activL versus controls (59% vs. 43%; P<0.01). Mean back pain severity improved by 74% with activL and 68% with controls. Oswestry Disability Index scores decreased by 67% and 61% with activL and controls, respectively. Patient satisfaction with treatment was over 90% in both groups at 2 years. Return to work was approximately 1 month shorter (P=0.08) with activL versus controls. The rate of device-related serious adverse events was lower in patients treated with activL versus controls (12% vs. 19%; P=0.13). Surgical reintervention rates at the index level were comparable (activL 2.3%, control 1.9%).

Conclusion. The single-level activL TDR is safe and effective for the treatment of symptomatic lumbar DDD through 2 years.

Level of Evidence: 2

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Assessment of adjacent-segment mobility after cervical disc replacement versus fusion: RCT with 1 year’s results

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 uninvolved vertebrae have not been subjected to studies so far.

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.

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.

The adjacent segment showed a significantly higher segmental motion in all three-dimensional axes in comparison to the segment treated with prostheses (P< 0.05). In the fusion group the segmental motion of the adjacent segment was significantly higher in all three dimensional axes (P< 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> 0.05) 1 year after surgery. Regarding the clinical results, there was no significant difference in pain relief between both groups (P> 0.05).

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.

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Prospective, Randomized, Double-Blind Clinical Study Evaluating the Correlation of Clinical Outcomes and Cervical Sagittal Alignment

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 or parallel allografts were used for fusion.

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).

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).

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.

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Does minimally invasive lumbar disc surgery result in less muscle injury than conventional surgery? A randomized controlled trial

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 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.

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.

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.

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A Comparative Analysis of the Results of Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Compression Fractures

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: 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.

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.

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.

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Colloid Cysts of the Third Ventricle: Endoscopic Versus Microsurgical Removal

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 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.

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.

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.

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.

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Early Rehabilitation Targeting Cognition, Behavior, and Motor Function After Lumbar Fusion A Randomized Controlled Trial

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 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.

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.

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.

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.

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New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS)

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 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.

Findings: 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<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).

Interpretation: 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.

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Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage

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, 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.

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.

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.

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Aceclofenac–tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone

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 back pain.

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.

Aceclofenac–tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 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 < 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.

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.

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Wound healing after craniotomy: a randomized trial comparing scalp clips to artery forceps for scalp hemostasis

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 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 > 16 years of age undergoing craniotomies expected to last > 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.

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)

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.


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No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy

Eur Spine J (2009) 18:1843–1850 DOI 10.1007/s00586-009-1044-3

Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non- invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. Reg U.S.). IDD Therapy consists of intermittent traction sessions in the Accu-SPINA device (Steadfast Corporation Ltd, Essex, UK), an FDA approved, class II medical device. The intervertebral disc and facet joints are unloaded through axial distraction, positioning and relaxation cycles. The purpose of this study is to investigate the effect of IDD Therapy when added to a standard graded activity program for chronic LBP patients. In a single blind, single centre, randomized controlled trial; 60 consecutive patients were assigned to either the SHAM or the IDD Therapy. All subjects received the standard conservative therapeutic care (graded activity) and 20 sessions in the Accu-SPINA device. The traction weight in the IDD Therapy was systematically increased until 50% of a person’s body weight plus 4.45 kg (10 lb) was reached. The SHAM group received a non-therapeutic traction weight of 4.45 kg in all sessions. The main outcome was assessed using a 100-mm visual analogue scale (VAS) for LBP. Secondary outcomes were VAS scores for leg pain, Oswestry Disability Index (ODI), Short-Form 36 (SF-36). All parameters were measured before and 2, 6 and 14 weeks after start of the treatment. Fear of (re)injury due to movement or activities (Tampa Scale for Kinesiophobia), coping strategies (Utrecht Coping List) and use of pain medication were recorded before and at 14 weeks. A repeated measures analysis was performed. The two groups were comparable at baseline in terms of demographic, clinical and psychological characteristics, indicating that the random allocation had succeeded. VAS low back pain improved significantly from 61 (±25) to 32 (±27) with the IDD protocol and 53 (±26) to 36 (±27) in the SHAM protocol. Moreover, leg pain, ODI and SF-36 scores improved significantly but in both groups. The use of pain medication decreased significantly, whereas scores for kinesiophobia and coping remained at the same non-pathological level. None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.

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Minimally Invasive Lumbar Discectomy Had Worse Outcome than Conventional Open Microdiscectomy. A Randomized Controlled Trial

JAMA. 2009;302(2):149-158.

Context Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking of its efficacy.

Objective To determine outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy.

Design, Setting, and Patients The Sciatica Micro-Endoscopic Diskectomy randomized controlled trial was conducted among 328 patients aged 18 to 70 years who had persistent leg pain (>8 weeks) due to lumbar disk herniations at 7 general hospitals in the Netherlands from January 2005 to October 2006. Patients and observers were blinded during the follow-up, which ended 1 year after final enrollment.

Interventions Tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161).

Main Outcome Measures The primary outcome was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica (score range: 0-23, with higher scores indicating worse functional status) at 8 weeks and 1 year after randomization. Secondary outcomes were scores on the visual analog scale for leg pain and back pain (score range: 0-100 mm) and patient’s self-report of recovery (measured on a Likert 7-point scale).

Results Based on intention-to-treat analysis, the mean RDQ score during the first year after surgery was 6.2 (95% confidence interval [CI], 5.6 to 6.8) for tubular diskectomy and 5.4 (95% CI, 4.6 to 6.2) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, –0.2 to 1.7). At 8 weeks after surgery, the RDQ mean (SE) score was 5.8 (0.4) for tubular diskectomy and 4.9 (0.5) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, –0.4 to 2.1). At 1 year, the RDQ mean (SE) score was 4.7 (0.5) for tubular diskectomy and 3.4 (0.5) for conventional microdiskectomy (between-group mean difference, 1.3; 95% CI, 0.03 to 2.6) in favor of conventional microdiskectomy. On the visual analog scale, the 1-year between-group mean difference in improvement was 4.2 mm (95% CI, 0.9 to 7.5 mm) for leg pain and 3.5 mm (95% CI, 0.1 to 6.9 mm) for back pain in favor of conventional microdiskectomy. At 1 year, 107 of 156 patients (69%) assigned to tubular diskectomy reported a good recovery vs 120 of 151 patients (79%) assigned to conventional microdiskectomy (odds ratio, 0.59 [95% CI, 0.35 to 0.99]; P = .05).

Conclusions Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score. Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery.

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A Randomized, Double-blinded Comparison of Ondansetron, Granisetron, and Placebo for Prevention of Postoperative Nausea and Vomiting After Supratentorial Craniotomy

Journal of Neurosurgical Anesthesiology: July 2009 – Volume 21 – Issue 3 – pp 226-230. doi: 10.1097/ANA.0b013e3181a7beaa

Postoperative nausea and vomiting (PONV) are frequent and distressing complications after neurosurgical procedures. We evaluated the efficacy of ondansetron and granisetron to prevent PONV after supratentorial craniotomy. In a randomized double-blind, placebo controlled trial, 90 adult American Society of Anesthesiologists I, II patients were included in the study. A standard anesthesia technique was followed. Patients were divided into 3 groups to receive either placebo (saline), ondansetron 4 mg, or granisetron 1 mg intravenously at the time of dural closure. After extubation, episodes of nausea and vomiting were noted for 24 hours postoperatively. Statistical analysis was performed using χ2 test and 1-way analysis of variance. Demographic data, duration of surgery, intraoperative fluids and analgesic requirement, and postoperative pain (visual analog scale) scores were comparable in all 3 groups. It was observed that the incidence of vomiting in 24 hours, severe emetic episodes, and requirement of rescue antiemetics were less in ondansetron and granisetron groups as compared with placebo (P<0.001). Both the study drugs had comparable effect on vomiting. However, the incidence of nausea was comparable in all 3 groups (P=0.46). A favorable influence on the patient satisfaction scores, and number needed to prevent emesis was seen in the 2 drug groups. No significant correlation was found between neurosurgical factors (presence of midline shift, mass effect, pathologic diagnosis of tumor, site of tumor) and the occurrence of PONV. We conclude that ondansetron 4 mg and granisetron 1 mg are comparably effective at preventing emesis after supratentorial craniotomy. However, neither drugs prevented nausea effectively.

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