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Daily bibliographic review of the Neurosurgery Department. La Fe University Hospital. Valencia, Spain

A 5- to 8-year randomized study on the treatment of cervical radiculopathy: anterior cervical decompression and fusion plus physiotherapy versus physiotherapy alone

Journal of Neurosurgery: Spine 26(1):19-27

The aim of this study was to evaluate the 5- to 8-year outcome of anterior cervical decompression and fusion (ACDF) combined with a structured physiotherapy program as compared with that following the same physiotherapy program alone in patients with cervical radiculopathy. No previous prospective randomized studies with a follow-up of more than 2 years have compared outcomes of surgical versus nonsurgical intervention for cervical radiculopathy.

METHODS: Fifty-nine patients were randomized to ACDF surgery with postoperative physiotherapy (30 patients) or to structured physiotherapy alone (29 patients). The physiotherapy program included general and specific exercises as well as pain coping strategies. Outcome measures included neck disability (Neck Disability Index [NDI]), neck and arm pain intensity (visual analog scale [VAS]), health state (EQ-5D questionnaire), and a patient global assessment. Patients were followed up for 5–8 years.

RESULTS: After 5–8 years, the NDI was reduced by a mean score% of 21 (95% CI 14–28) in the surgical group and 11% (95% CI 4%–18%) in the nonsurgical group (p = 0.03). Neck pain was reduced by a mean score of 39 mm (95% CI 26–53 mm) compared with 19 mm (95% CI 7–30 mm; p = 0.01), and arm pain was reduced by a mean score of 33 mm (95% CI 18–49 mm) compared with 19 mm (95% CI 7–32 mm; p = 0.1), respectively. The EQ-5D had a mean respective increase of 0.29 (95% CI 0.13–0.45) compared with 0.14 (95% CI 0.01–0.27; p = 0.12). Ninety-three percent of patients in the surgical group rated their symptoms as “better” or “much better” compared with 62% in the nonsurgical group (p = 0.005). Both treatment groups experienced significant improvement over baseline for all outcome measures.

CONCLUSIONS: In this prospective randomized study of 5- to 8-year outcomes of surgical versus nonsurgical treatment in patients with cervical radiculopathy, ACDF combined with physiotherapy reduced neck disability and neck pain more effectively than physiotherapy alone. Self-rating by patients as regards treatment outcome was also superior in the surgery group. No significant differences were seen between the 2 patient groups as regards arm pain and health outcome.

 

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

J Neurosurg 126:81–90, 2017

Autologous bone is usually used to reconstruct skull defects following decompressive surgery. However, it is associated with a high failure rate due to infection and resorption. The aim of this study was to see whether it would be cost-effective to use titanium as a primary reconstructive material.

Methods Sixty-four patients were enrolled and randomized to receive either their own bone or a primary titanium cranioplasty. All surgical procedures were performed by the senior surgeon. Primary and secondary outcome measures were assessed at 1 year after cranioplasty.

Results There were no primary infections in either arm of the trial. There was one secondary infection of a titanium cranioplasty that had replaced a resorbed autologous cranioplasty. In the titanium group, no patient was considered to have partial or complete cranioplasty failure at 12 months of follow-up (p = 0.002) and none needed revision (p = 0.053). There were 2 deaths unrelated to the cranioplasty, one in each arm of the trial. Among the 31 patients who had an autologous cranioplasty, 7 patients (22%) had complete resorption of the autologous bone such that it was deemed a complete failure. Partial or complete autologous bone resorption appeared to be more common among young patients than older patients (32 vs 45 years old, p = 0.013). The total cumulative cost between the 2 groups was not significantly different (mean difference A$3281, 95% CI $-9869 to $3308; p = 0.327).

Conclusions Primary titanium cranioplasty should be seriously considered for young patients who require reconstruction of the skull vault following decompressive craniectomy. Clinical trial registration no.: ACTRN12612000353897 (anzctr.org.au)

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.

 

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis

Three-Year Follow-up of the Prospective, Randomized, Controlled Trial of Coflex Interlaminar Stabilization vs Instrumented Fusion in Patients With Lumbar Stenosis

Neurosurgery 79:169–181, 2016

Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations.

OBJECTIVE: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level.

METHODS: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States. Baseline and followup visits collected demographics, clinical, and radiographic status. The primary endpoint was a measure of composite clinical success 24 months postoperatively. For this current 36-month analysis, composite clinical success was calculated using analogous methods.

RESULTS: Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = 210%) and superiority of cofle Interlaminar Stabilization vs fusion were .0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement ($15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005).

CONCLUSION: Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels.

Cost Utility Analysis of the Cervical Artificial Disc vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease: 5-Year Follow-up

mobi-c

Neurosurgery 79:135–145, 2016

The cervical total disc replacement (cTDR) was developed to treat cervical degenerative disc disease while preserving motion.

OBJECTIVE: Cost-effectiveness of this intervention was established by looking at 2-year follow-up, and this update reevaluates our analysis over 5 years.

METHODS: Data were derived from a randomized trial of 330 patients. Data from the 12- Item Short Form Health Survey were transformed into utilities by using the SF-6D algorithm. Costs were calculated by extracting diagnosis-related group codes and then applying 2014 Medicare reimbursement rates. A Markov model evaluated qualityadjusted life years (QALYs) for both treatment groups. Univariate and multivariate sensitivity analyses were conducted to test the stability of the model. The model adopted both societal and health system perspectives and applied a 3% annual discount rate.

RESULTS: The cTDR costs $1687 more than anterior cervical discectomy and fusion (ACDF) over 5 years. In contrast, cTDR had $34 377 less productivity loss compared with ACDF. There was a significant difference in the return-to-work rate (81.6% compared with 65.4% for cTDR and ACDF, respectively; P = .029). From a societal perspective, the incremental cost-effective ratio (ICER) for cTDR was 2$165 103 per QALY. From a health system perspective, the ICER for cTDR was $8518 per QALY. In the sensitivity analysis, the ICER for cTDR remained below the US willingness-to-pay threshold of $50 000 per QALY in all scenarios (2$225 816 per QALY to $22 071 per QALY).

CONCLUSION: This study is the first to report the comparative cost-effectiveness of cTDR vs ACDF for 2-level degenerative disc disease at 5 years. The authors conclude that, because of the negative ICER, cTDR is the dominant modality.

Clinical effect of different shunt valve settings in iNPH

Hydrocephalus

J Neurosurg 124:359–367, 2016

The study aim was to examine the effect of gradually reducing the opening pressure on symptoms and signs in the shunt treatment of idiopathic normal pressure hydrocephalus (iNPH).

Methods In this prospective double-blinded, randomized, controlled, double-center study on patients with iNPH, a ventriculoperitoneal shunt with an adjustable Codman Medos Valve was implanted in 68 patients randomized into 2 groups. In 1 group (the 20–4 group) the valve setting was initially set to 20 cm H2O and gradually reduced to 4 cm H2O over the course of the 6-month study period. In the other group (the 12 group), the valve was kept at a medium level of 12 cm H2O during the whole study period. All patients were clinically evaluated using 4 tests preoperatively as well as postoperatively at 1, 2, 3, 4, and 6 months. The test scores between the 2 groups (20–4 and 12) were compared for each clinical evaluation.

Results Fifty-five patients (81%) were able to complete the study. There were no significant differences between the 2 groups (20–4 and 12) preoperatively or at any time postoperatively. Both groups exhibited significant clinical improvement after shunt insertion at all valve settings compared with the preoperative score, with the greatest improvement observed at the first postoperative evaluation. The clinical improvement was significant within the first 3 months, and thereafter no significant improvement was seen in either group.

Conclusions Gradual reduction of the valve setting from 20 to 4 cm H2O did not improve outcome compared with a fixed valve setting of 12 cm H2O. Improvement after shunt surgery in iNPH patients was evident within 3 months, irrespective of valve setting.

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.

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

Shunt complications and opening pressure

External lumbar drain- A pragmatic test for prediction of shunt outcomes in idiopathic normal pressure hydrocephalus

J Neurosurg 121:1257–1263, 2014

This study was undertaken to investigate whether a gradual reduction of the valve setting (opening pressure) decreases the complication rate in patients with idiopathic normal-pressure hydrocephalus (iNPH) treated with a ventriculoperitoneal (VP) shunt.

Methods. In this prospective double-blinded, randomized, controlled, dual-center study, a VP shunt with an adjustable valve was implanted in 68 patients with iNPH, randomized into two groups. In one group (the 20–4 group) the valve setting was initially set to 20 cm H2O and gradually reduced to 4 cm H2O over the course of the 6-month study period. In the other group (the 12 group), the valve was kept at a medium pressure setting of 12 cm H2O during the whole study period. The time to and type of complications (hematoma, infection, and mechanical problems) as well as overdrainage symptoms were recorded. Symptoms, signs, and outcome were assessed by means of the iNPH scale and the NPH grading scale.

Results. Six patients in the 20–4 group (22%) and 7 patients in the 12 group (23%) experienced a shunt complication; 9 had subdural hematomas, 3 mechanical obstructions, and 1 infection (no significant difference between groups). The frequency of overdrainage symptoms was significantly higher for a valve setting ≤ 12 cm H2O compared with a setting > 12 cm H2O. The 20–4 group had a higher improvement rate (88%) than the 12 group (62%) (p = 0.032). There was no significant relationship between complications and body mass index, the use of an antisiphon device, or the use of anticoagulants.

Conclusions. Gradual lowering of the valve setting to a mean of 7 cm H2O led to the same rate of shunt complications and overdrainage symptoms as a fixed valve setting at a mean of 13 cm H2O but was associated with a significantly better outcome.

Cervical Spondylotic Myelopathy Surgical Trial: Randomized, Controlled Trial Design and Rationale

Cervical Spondylotic Myelopathy Surgical Trial- Randomized, Controlled Trial Design and Rationale

Neurosurgery 75:334–346, 2014

Cervical spondylotic myelopathy (CSM) is the most common cause of spinal cord dysfunction in the world. There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM.

OBJECTIVE: To determine whether ventral surgery is associated with superior Short Form- 36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal (laminectomy/fusion or laminoplasty) surgery for the treatment of CSM, to investigate whether postoperative sagittal balance is an independent predictor of overall outcome, and to compare health resource use for ventral and dorsal procedures.

METHODS: The study is a randomized, controlled trial with a nonrandomized arm for patients who are eligible but decline randomization. Two hundred fifty patients (159 randomized) with CSM from 11 sites will be recruited over 18 months. The primary outcome is the Short Form-36 Physical Component Summary score. Secondary outcomes include disease-specific outcomes, overall health-related quality of life (EuroQOL 5-dimension questionnaire), and health resource use.

EXPECTED OUTCOMES: This will be the first randomized, controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM.

DISCUSSION: A National Institutes of Health-funded (1R13AR065834-01) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol. Study investigators, coordinators, and major stakeholders were able to attend and discuss strengths of, limitations of, and concerns about the study. The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute (CE-1304-6173). The trial began enrollment on April 1, 2014.

Very Late Complications of Cervical Arthroplasty

Very Late Complications of Cervical Arthroplasty

Spine 2013;38:2223––2226

Prospective, single-site, randomized, Food and Drug Administration––approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices.

Objective. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Summary of Background Data. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less.

Methods. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Results. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms.

Conclusion. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed devicerelated complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery.

Level of Evidence: 1

Who Should Undergo Surgery for Degenerative Spondylolisthesis?

Spondylolisthesis

Spine 2013;38:1799–1811

Combined prospective randomized controlled trial and observational cohort study of degenerative spondylolisthesis (DS) with an as-treated analysis.

Objective. To determine modifi ers of the treatment effect (TE) of surgery (the difference between surgical and nonoperative outcomes) for DS using subgroup analysis. Summary of Background Data. Spine Patient Outcomes Research Trial demonstrated a positive surgical TE for DS at the group level. However, individual characteristics may affect TE.

Methods. Patients with DS were treated with either surgery (n = 395) or nonoperative care (n = 210) and were analyzed according to treatment received. Fifty-fi ve baseline variables were used to defi ne subgroups for calculating the time-weighted average TE for the Oswestry Disability Index during 4 years (TE = Δ Oswestry Disability Index surgery − Δ Oswestry Disability Index nonoperative ). Variables with signifi cant subgroup-by-treatment interactions ( P < 0.05) were simultaneously entered into a multivariate model to select independent TE predictors.

Results. All analyzed subgroups that included at least 50 patients improved signifi cantly more with surgery than with nonoperative treatment ( P < 0.05). Multivariate analyses demonstrated that age 67 years or less (TE − 15.7 vs. − 11.8 for age > 67, P = 0.014); female sex (TE − 15.6 vs. − 11.2 for males, P = 0.01); the absence of stomach problems (TE − 15.2 vs. − 11.3 for those with stomach problems, P = 0.035); neurogenic claudication (TE − 15.3 vs. − 9.0 for those without claudication, P = 0.004); refl ex asymmetry (TE − 17.3 vs. − 13.0 for those without asymmetry, P = 0.016); opioid use (TE − 18.4 vs. − 11.7 for those not using opioids, P < 0.001); not taking antidepressants (TE − 14.5 vs. − 5.4 for those on antidepressants, P = 0.014); dissatisfaction with symptoms (TE − 14.5 vs. − 8.3 for those satisfi ed or neutral, P = 0.039); and anticipating a high likelihood of improvement with surgery (TE − 14.8 vs. − 5.1 for anticipating a low likelihood of improvement with surgery, P = 0.019) were independently associated with greater TE.

Conclusion. Patients who met strict inclusion criteria improved more with surgery than with nonoperative treatment, regardless of other specific characteristics. However, TE varied signifi cantly across certain subgroups.

Level of Evidence: 3

X-Stop Versus Decompressive Surgery for Lumbar Neurogenic Intermittent Claudication

X-stop

Spine 2013 ;38:1436–1442

Objective. To compare the outcome of indirect decompression by means of the X-Stop (Medtronics Inc., Minneapolis, MN) implant with conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.

Summary of Background Data. Decompression is currently the “gold standard” for lumbar spinal stenosis but is affl icted with complications and a certain number of dissatisfi ed patients. Interspinous implants have been on the market for more than 10 years, but no prospective study comparing its outcome with decompression has been performed.

Methods. After power calculation, 100 patients were included: 50 in the X-Stop group and 50 in the decompression group. Patients with symptomatic 1- or 2-level lumbar spinal stenosis and neurogenic claudication relieved on fl exion were included. X-Stop operations were performed under local anesthesia. The mean patient age was 69 (49–89) years, and the male/female distribution was 56/44. Minimal dural sac area was in all cases except two 80 mm 2 or less. The noninferiority hypothesis included 6, 12, and 24 months of follow-up, and included. intention-to-treat as well as as-treated analyses. The primary outcome meansure was the Zürich Claudication Questionnaire, and the secondary outcome measures was the visual analogue scale pain, Short-Form 36 (SF-36), complications, and reoperations.

Results. The primary and secondary outcome measures of patients in both groups improved signifi cantly. The results were similar at 6, 12, and 24 months and at no time point could any statistical difference between the 2 types of surgery be identifi ed. Three patients (6%) in the decompression group underwent further surgery, compared with 13 patients (26%) in the X-Stop group ( P = 0.04). Results were identical in intention-to-treat and astreated analyses.

Conclusion. For spinal stenosis with neurogenic claudication, decompressive surgery as well as X-Stop are appropriate procedures. Similar results were achieved in both groups, however, with a higher number of reoperations in the X-Stop group. Patients having X-Stop removal and decompression experienced results similar to those randomized to primary decompression.

Level of Evidence: 1

Oxiplex Reduces Leg Pain, Back Pain, and Associated Symptoms After Lumbar Discectomy

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.

Randomized, Controlled, Multicenter, Clinical Trial Comparing BRYAN Cervical Disc Arthroplasty With Anterior Cervical Decompression and Fusion in China

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.

Sonothrombolysis for acute ischemic stroke: a systematic review of randomized controlled trials

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.

Results of a Prospective Randomized Study Comparing a Novel Retractor With a Caspar Retractor in Anterior Cervical Surgery

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.

A Randomized and Blinded Single-Center Trial Comparing the Effect of Intracranial Pressure and Intracranial Pressure Wave Amplitude-Guided Intensive Care Management on Early Clinical State and 12-Month Outcome in Patients With Aneurysmal Subarachnoid Hemorrhage

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.

Results of the Prospective, Randomized, Multicenter Clinical Trial Evaluating a Biosynthesized Cellulose Graft for Repair of Dural Defects

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.

Tubular Diskectomy vs Conventional Microdiskectomy for the Treatment of Lumbar Disk-Related Sciatica: Cost Utility Analysis Alongside a Double-Blind Randomized Controlled Trial

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.

Neurosurgery Department. “La Fe” University Hospital. Valencia, Spain

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