SPINE Volume 37, Number 8, pp 631–641
Study Design. Prospective, randomized, blinded clinical trial.
Objective. To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy.
Summary of Background Data. Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy.
Methods. Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations.
Results. There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients ( P = 0.05). The geltreated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically signifi cant reduction of leg pain and back pain ( P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs . 6).
Conclusion. These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.
Spine 2012 ; 37 : 433 – 438. DOI: 10.1097/BRS.0b013e31822699fa
Study Design. Prospective, randomized, controlled, multicenter clinical trial.
Objective. To compare outcomes of cervical disc arthroplasty with those of anterior cervical decompression and fusion (ACDF) in a Chinese population.
Summary of Background Data. Cervical disc arthroplasty has been found to be superior to ACDF for maintaining range of motion (ROM) at the index spinal segment and possibly will avoid abnormal stress to adjacent segments.
Methods. A total of 120 patients from 3 large hospitals in China were randomly assigned to treatment with cervical disc arthroplasty (n = 60) using the BRYAN prosthesis or ACDF (n = 60) and were observed postoperatively for 24 months.
Results. The 2 groups had similar preoperative demographics and baseline characteristics including ROM, neck disability index, and visual analogue scale for neck and arm pain. The total disc replacement (TDR) group had a significantly longer operation time than the ACDF group ( P < 0.001). Outcome data obtained after 24 months revealed a significant difference between the groups in mean change from baseline in ROM at the index level ( P < 0.001); ROM was maintained in the TDR group but reduced in the ACDF group. There were no signifi cant between-group differences in the baseline changes in neck disability index or visual analogue scale scores for pain. One patient in the TDR group and 4 patients in the ACDF group required reoperations.
Conclusion. At 24 months after surgery, the cervical disc prosthesis yielded good clinical results while maintaining ROM at the index level. Cervical disc arthroplasty appears to be a viable alternative to ACDF.
Neurosurg Focus 32 (1):E5, 2012. 10.3171/2011.10.FOCUS11251
Sonothrombolysis has recently been considered an emerging modality for the treatment of stroke. The purpose of the present paper was to review randomized clinical studies concerning the effects of sonothrombolysis associated with tissue plasminogen activator (tPA) on acute ischemic stroke.
METHODS
Systematic searches for literature published between January 1996 and July 2011 were performed for studies regarding sonothrombolysis combined with tPA for acute ischemic stroke. Only randomized controlled trials were included. Data extraction was based on ultrasound variables, patient characteristics, and outcome variables (rate of intracranial hemorrhages and arterial recanalization).
RESULTS
Four trials were included in this study; 2 trials evaluated the effect of transcranial Doppler (TCD) ultrasonography on sonothrombolysis, and 2 addressed transcranial color-coded duplex (TCCD) ultrasonography. The frequency of ultrasound waves varied from 1.8 to 2 MHz. The duration of thrombus exposure to ultrasound energy ranged from 60 to 120 minutes. Sample sizes were small, recanalization was evaluated at different time points (60 and 120 minutes), and inclusion criteria were heterogeneous. Sonothrombolysis combined with tPA did not lead to an increase in symptomatic intracranial hemorrhagic complications. Two studies demonstrated that patients treated with ultrasound combined with tPA had statistically significant higher rates of recanalization than patients treated with tPA alone.
CONCLUSIONS
Despite the heterogeneity and the limitations of the reviewed studies, there is evidence that sonothrombolysis associated with tPA is a safe procedure and results in an increased rate of recanalization in the setting of acute ischemic stroke when wave frequencies and energy intensities of diagnostic ultrasound systems are used.
Neurosurgery 69[ONS Suppl 2]:ons156–ons160, 2011 DOI: 10.1227/NEU.0b013e318219565f
Retraction injury might explain the soft tissue complications seen after anterior cervical surgery. A novel retractor system (Seex retractor system [SRS]) that uses a principle of bone fixation with rotation has been shown to reduce retraction pressure in a cadaveric model of anterior cervical decompression and fusion.
OBJECTIVE: To compare the conventional Cloward-style retractor (CRS) with the SRS in a prospective randomized clinical trial.
METHODS: After ethics and study registration (ACTRN 12608000430336), eligible patients were randomized to either the CRS or SRS before 1- or 2-level anterior cervical decompression and fusion. The pressure beneath the medial retractor blade was recorded with a thin pressure transducer strip. Postoperative sore throat, dysphagia, and dysphonia were assessed after 1, 7, and 28 days.
RESULTS: Twenty-six patients were randomized. There were no serious complications. Complication rates were low with a trend favoring SRS that was not statistically different. Average retraction pressure with SRS was 1.9 mm Hg and with CRS was 5.6 mm Hg (P , .001 on F test; P = .002 on 2-tailed t test). Mean average peak retraction pressure with the SRS was 3.4 mm Hg and with the CRS was 20 mmHg (P , .001 on F test; P = .005 on 2-tailed t test).
CONCLUSION: The new retractor is safe, and statistically similar complication rates were observed with the 2 systems. The SRS generated significantly less retraction pressure compared with the CRS. This difference can be explained by the different principles governing the function of these retractors. Bone fixation gives stability and rotation reduces tissue pressure, both desirable in a retractor.
Neurosurgery 69:1105–1115, 2011 DOI: 10.1227/NEU.0b013e318227e0e1
In patients with aneurysmal subarachnoid hemorrhage (SAH), preliminary results indicate that the amplitude of the single intracranial pressure (ICP) wave is a better predictor of the early clinical state and 6-month outcome than the mean ICP.
OBJECTIVE: To perform a randomized and blinded single-center trial comparing the effect of mean ICP vs mean ICP wave amplitude (MWA)-guided intensive care management on early clinical state and outcome in patients with aneurysmal SAH.
METHODS: Patients were randomized to 2 different types of ICP management: maintenance of mean ICP less than 20 mm Hg and MWA less than 5mm Hg. Early clinical state was assessed daily using the Glasgow Coma Scale. The primary efficacy variable was 12-month outcome in terms of the Rankin Stroke Score.
RESULTS: Ninety-seven patients were included in the study. There were no significant differences in treatment between the 2 groups apart from a larger volume of cerebrospinal fluid drained during week 1 in the MWA group. There was a tendency toward higher Glasgow Coma Scale scores in the MWA group during weeks 1 (P = .08) and 2 (P = .07). Outcome in terms of Rankin Stroke Score at 12 months was significantly better in the MWA group (P < .05).
CONCLUSION: This randomized and blinded trial disclosed a significant better primary efficacy variable (Rankin Stroke Score after 12 months) in the MWA patient group. We suggest that proactive intensive care management with MWA-tailored cerebrospinal fluid drainage during the first week improves aneurysmal SAH outcome.
Neurosurgery 69:1093–1104, 2011 DOI: 10.1227/NEU.0b013e3182284aca
After intradural cranial surgery, a dural substitute is often required for dural closure. Although preferred, limitations of autograft include local availability and additional surgical site morbidity. Thus, allografts, xenografts, and synthetics are frequently used.
OBJECTIVE: To report 6-month results of a randomized, controlled trial of a biosynthesized cellulose (BSC) composed duraplasty device compared with commercially available dural replacements.
METHODS: A total of 99 patients (62 BSC; 37 control) were treated on protocol, using a 2:1 (BSC:control) blocked randomization schedule. Physical examinations were performed pre- and postoperatively within 10 days and at 1, 3, and 6 months. Magnetic resonance imaging was performed preoperatively and at 6 months. The primary study endpoint was the absence of pseudomeningocele and extracerebral fluid collection confirmed radiographically and the absence of cerebrospinal fluid fistula at 6 months.
RESULTS: At 6 months, the primary hypothesis, noninferiority of the BSC implant compared with the control group, was confirmed (P = .0206). Overall success was achieved by 96.6% of BSC and 97.1% of control patients. No significant difference was revealed between treatment groups for surgical site infection (P = 1.0000) or wound healing assessment (P $ .3685) outcomes, or radiologic endpoints (P $ .4061). Device strength and seal quality favored BSC.
CONCLUSION: This randomized, controlled trial establishes BSC as noninferior to commercially available dural replacement devices. BSC offers a hypothetical advantage concerning prion and other infectious agent exposure; superior handling qualities are evident. Longer term data are necessary to identify limitations of BSC and its potential equivalence to the gold standard of pericranium.
Neurosurgery 69:829–836, 2011 DOI: 10.1227/NEU.0b013e31822578f6
Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica caused by lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence of its efficacy is lacking.
OBJECTIVE: To determine whether a favorable cost-effectiveness for tubular diskectomy compared with conventional microdiskectomy is attained.
METHODS: Cost utility analysis was performed alongside a double-blind randomized controlled trial conducted among 325 patients with lumbar disk related sciatica lasting .6 to 8 weeks at 7 Dutch hospitals comparing tubular diskectomy with conventional microdiskectomy. Main outcome measures were quality-adjusted life-years at 1 year and societal costs, estimated from patient reported utilities (US and Netherlands EuroQol, Short Form Health Survey-6D, and Visual Analog Scale) and diaries on costs (health care, patient costs, and productivity).
RESULTS: Quality-adjusted life-years during all 4 quarters and according to all utility measures were not statistically different between tubular diskectomy and conventional microdiskectomy (difference for US EuroQol, 20.012; 95% confidence interval, 20.046 to 0.021). From the healthcare perspective, tubular diskectomy resulted in nonsignificantly higher costs (difference US $460; 95% confidence interval, 2243 to 1163). From the societal perspective, a nonsignificant difference of US $1491 (95% confidence interval, 21335 to 4318) in favor of conventional microdiskectomy was found. The nonsignificant differences in costs and quality-adjusted life-years in favor of conventional microdiskectomy result in a low probability that tubular diskectomy is more cost-effective than conventional microdiskectomy.
CONCLUSION: Tubular diskectomy is unlikely to be cost-effective compared with conventional microdiskectomy.
Journal of Neurosurgery: Spine Oct 2011 / Vol. 15 / No. 4 / Pages 348-358. DOI: 10.3171/2011.5.SPINE10769.
Cervical total disc replacement (CTDR) represents a relatively novel procedure intended to address some of the shortcomings associated with anterior cervical discectomy and fusion (ACDF) by preserving motion at the treated level. This prospective, randomized, multicenter study evaluates the safety and efficacy of a new metal-on-metal CTDR implant (Kineflex|C) by comparing it with ACDF in the treatment of single-level spondylosis with radiculopathy.
METHODS
The study was a prospective, randomized US FDA Investigational Device Exemption (IDE) pivotal trial conducted at 21 centers across the US. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS) scores, and a composite measure of clinical success. Patients were randomized to CTDR using the Kineflex|C (SpinalMotion, Inc.) cervical artificial disc or ACDF using structural allograft and an anterior plate.
RESULTS
A total of 269 patients were enrolled and randomly assigned to either CTDR (136 patients) or to ACDF (133 patients). There were no significant differences between the CTDR and ACDF groups when comparing operative time, blood loss, length of hospital stay, or the reoperation rate at the index level. The overall success rate was significantly greater in the CTDR group (85%) compared with the ACDF group (71%) (p = 0.05). In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 24-month follow-up (p < 0.0001). Similarly, the VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 24-month follow-up (p < 0.0001). The range of motion (ROM) in the CTDR group decreased at 3 months but was significantly greater than the preoperative mean at 12- and 24-month follow-up. The ROM in the ACDF group was significantly reduced by 3 months and remained so throughout the follow-up. Adjacent-level degeneration was also evaluated in both groups from preoperatively to 2-year follow-up and was classified as none, mild, moderate, or severe. Preoperatively, there were no significant differences between groups when evaluating the different levels of adjacent-level degeneration. At the 2-year follow-up, there were significantly more patients in the ACDF group with severe adjacent-level radiographic changes (p < 0.0001). However, there were no significant differences between groups in adjacent-level reoperation rate (7.6% for the Kineflex|C group and 6.1% for the ACDF group).
CONCLUSIONS
Cervical total disc replacement allows for neural decompression and clinical results comparable to ACDF. Kineflex|C was associated with a significantly greater overall success rate than fusion while maintaining motion at the index level. Furthermore, there were significantly fewer Kineflex|C patients showing severe adjacent-level radiographic changes at the 2-year follow-up. These results from a prospective, randomized study support that Kineflex|C CTDR is a viable alternative to ACDF in select patients with cervical radiculopathy
Eur Spine J (2011) 20:1001–1011. DOI 10.1007/s00586-010-1607-3
This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported.
In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (-45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ- 5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the ‘‘non-difference’’ in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost- effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (-73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK.
It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time.
Neurosurgery 69:135–144, 2011 DOI: 10.1227/NEU.0b013e318214a98c
Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking.
OBJECTIVE: To evaluate the 2-year results of tubular diskectomy compared with conventional microdiskectomy.
METHODS: Three hundred twenty-eight patients with persistent leg pain caused by lumbar disk herniation were randomly assigned to undergo tubular diskectomy (167 patients) or conventional microdiskectomy (161 patients). Main outcome measures were scores from Roland-Morris Disability Questionnaire for Sciatica, Visual Analog Scale for leg pain and low-back pain, and Likert self-rating scale of global perceived recovery.
RESULTS: On the basis of intention-to-treat analysis, there was no significant difference between tubular diskectomy and conventional microdiskectomy in Roland-Morris Disability Questionnaire for Sciatica scores during 2 years after surgery (between-group mean difference [∆] = 0.6; 95% confidence interval [CI], 20.3-1.6). Patients treated with tubular diskectomy reported more leg pain (∆ = 3.3 mm; 95% CI, 0.2-6.2) and more lowback pain (∆ = 3.0 mm; 95% CI, 20.2-6.3) than those patients treated with conventional microdiskectomy. At 2 years, 71% of patients assigned to tubular diskectomy documented a good recovery vs 77% of patients assigned to conventional microdiskectomy (odds ratio, 0.76; 95% CI, 0.45-1.28; P = .35). Repeated surgery rates within 2 years after tubular diskectomy and conventional microdiskectomy were 15% and 10%, respectively (P = .22).
CONCLUSION: Tubular diskectomy and conventional microdiskectomy resulted in similar functional and clinical outcomes. Patients treated with tubular diskectomy reported more leg pain and low-back pain, although the differences were small and not clinically relevant.
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.
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.
Neurosurgery 68:996–1005, 2011 DOI: 10.1227/NEU.0b013e3182096d84
Ventriculostomy-related infection (VRI) is a severe complication of external ventricular drain use, occurring in 5% to 23% of patients. Preventive measures for VRI include prolonged prophylactic systemic antibiotics (PSAs) and an antibioticcoated external ventricular drains (ac-EVDs).
OBJECTIVE: We performed a systematic review of all studies evaluating PSAs and ac-EVD for VRI prevention through July 2010.
METHODS: Two reviewers independently assessed eligibility and evaluated study quality based on pre-established criteria. Observational studies and randomized clinical trials (RCTs) that fulfilled inclusion criteria were included in the meta-analysis.
RESULTS: Three RCTs and 7 observational studies met our inclusion criteria and were included in the analysis. The type of antibiotics and VRI definitions varied among these studies. Pooled analysis showed a protective effect of PSAs and ac-EVDs for VRI (risk ratio: 0.32; 95% CI: 0.18-0.56). Results showed moderate heterogeneity (I2 = 53%) explained by the difference in quality among the studies and the inclusion of 1 large positive cohort study. The effect of PSAs and ac-EVDs was unrelated to the type of study (RCT or observational, P for interaction = .55), the route of antibiotic administration (PSAs or ac-EVDs, P = .13), or the quality of the studies (suboptimal vs good/excellent, P = .55).
CONCLUSION: RCTs and observational-derived evidence support the use of PSAs throughout the duration of external ventricular drainage; similarly, the use of ac-EVDs to prevent VRI seems to be beneficial. Available data are heterogeneous and of suboptimal quality. Further research is needed to confirm the findings of this meta-analysis. There are not sufficient data to compare the protective effect of ac-EVDs and PSAs.
Neurosurgery 68:571–581, 2011 DOI: 10.1227/NEU.0b013e3182093145
Randomized clinical trials (RCTs) have usually supported using heparin prophylaxis against venous thromboembolism (VTE) in patients undergoing cranial neurosurgery. The tradeoff between benefit and bleeding risk, however, has not been adequately characterized.
OBJECTIVE: To conduct a systematic review and meta-analysis assessing the extent to which low-dose unfractionated heparin (LDUH) or low-molecular-weight heparin (LMWH) prophylaxis reduces the rate of VTE and increases the rate of intracerebral hemorrhage (ICH) and other bleeding in patients undergoing elective cranial neurosurgery.
METHODS: We selected RCTs that evaluated LDUH or LMWH prophylaxis of VTE in patients undergoing elective cranial neurosurgery. A meta-analysis assessing heparins vs no heparin (either with or without mechanical methods) was performed.
RESULTS: Eight RCTs were identified. Six RCTs involving 1170 patients evaluated LDUH or LMWH vs a control group. Five of 6 trials found a significant reduction in the risk of symptomatic and asymptomatic VTE with heparin prophylaxis. The pooled risk ratio was 0.58 (95% confidence interval, 0.45-0.75). ICH was more common in those receiving heparin, but not statistically significantly. For every 1000 patients who receive heparin prophylaxis, 91 VTE events will be prevented (approximately 35 of which are proximal deep vein thrombosis or pulmonary embolism and 9 to 18 of which are symptomatic), whereas 7 ICHs and 28 more minor bleeds will occur.
CONCLUSION: Heparin prophylaxis for patients undergoing elective cranial neurosurgery reduces the risk of VTE but may also increase bleeding risks with a ratio of serious or symptomatic VTE relative to serious bleeding that is only slightly favorable.
Neurosurgery 68:431–436, 2011 DOI: 10.1227/NEU.0b013e318201c293
The development of newer diagnostic technologies has reduced the need for invasive electroencephalographic (EEG) studies in identifying the epileptogenic zone, especially in adult patients with mesial temporal lobe epilepsy and hippocampal sclerosis (MTLE-HS).
OBJECTIVE: To evaluate ictal single photon emission computed tomography (SPECT) in the evaluation and treatment of patients with MTLE-HS.
METHODS: MTLE patients were randomly assigned to those with (SPECT, n = 124) and without ictal SPECT (non-SPECT, n = 116) in an intent-to-treat protocol. Primary end points were the proportion of patients with invasive EEG studies, and those offered surgery. Secondary end points were the length of hospital stay and the proportion of patients with secondarily generalized seizures (SGS) during video-EEG, postsurgical seizure outcome, and hospital cost.
RESULTS: The proportion of patients offered surgery was similar in the SPECT (85%) and non-SPECT groups (81%), as well as the proportion that had invasive EEG studies (27% vs 23%). The mean duration of hospital stay was 1 day longer for the SPECT group (P , 0.001). SGS occurred in 51% of the SPECT and 26% of the non-SPECT group (P , 0.001). The cost of the presurgical evaluation was 35% higher for the SPECT compared with the non-SPECT group (P , 0.001). The proportion of patients seizure-free after surgery was similar in the SPECT (59%) compared with non-SPECT group (54%).
CONCLUSION: Ictal-SPECT did not add localizing value beyond what was provided by EEG-video telemetry and structural MRI that altered the surgical decision and outcome for MTLE-HS patients. Ictal-SPECT increased hospital stay was associated with increased costs and a higher chance of SGS during video-EEG monitoring. These findings support the notion that a protocol including ictal SPECT is equivalent to one without SPECT in the presurgical evaluation of adult patients with MTLE-HS.
Eur Spine J (2011) 20:51–57. 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.
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.
