Effect of Topical Steroid on Swallowing Following ACDF

Spine 2021;46:413–420

Study Design. Randomized, double-blinded, controlled trial.

Objective. To investigate the effectiveness of local intraoperative corticosteroids at decreasing the severity of swallowing difficulty following multilevel anterior cervical discectomy and fusion (ACDF).

Summary of Background Data. Dysphagia is a common complication after ACDF, and while for most patients the symptoms are mild and transient, some patients can suffer from severe dysphagia resulting in significant postoperative morbidity. Previous studies investigating the local application of corticosteroids are limited.

Methods. This was a prospective, randomized, double-blinded, controlled trial of patients undergoing 2, 3, or 4 level ACDF for radiculopathy and/or myelopathy. Patients undergoing multilevel ACDF were randomized to receive local corticosteroid in the retropharyngeal space or placebo (no steroid). Dysphagia was assessed using validated outcomes including the Eating Assessment Tool-10 (Eat-10) and Swallowing Quality of Life (SWALQOL) Questionnaire both preoperatively and at 1 day (POD1), 2 days (POD2), and 1-month postoperatively.

Results. One-hundred nine patients had a complete dataset available for analysis. Eat-10 scores were significantly lower in the Steroid group on POD2 (8 vs. 16, P¼0.03) and 1-month postoperatively (2 vs. 5, P¼0.03). A comparison of the individual SWAL-QOL subscale scores demonstrated that patients in the Steroid group had better scores than the Control group in various subscales at all postoperative time points. Significant differences were noted (always in favor of the Steroid group) in 40% of subscales on POD1, 60% of subscales on POD2, and 50% of subscales at 1-month postoperatively. The Control group never had a better SWAL-QOL subscale score at any time point postoperatively.

Conclusion. Local administration of corticosteroid after multilevel ACDF can decrease postoperative severity and symptomatology of dysphagia during the immediate postoperative period to 1-month postoperatively. The long-term effects of local steroid administration on fusion and other complications will need to be established in future studies.

Level of Evidence: 1

The Hydrogel Endovascular Aneurysm Treatment Trial (HEAT): A Randomized Controlled Trial of the Second-Generation Hydrogel Coil

Neurosurgery 86:615–624, 2020

Aneurysm recurrence after coiling has been associated with aneurysm growth, (re)hemorrhage, and a greater need for follow-up. The second-generation HydroCoil Embolic System (HES; MicroVention, Inc) consists of a platinum core with integrated hydrogel and was developed to reduce recurrence through enhancing packing density and healing within the aneurysm.

OBJECTIVE: To compare recurrence between the second-generation HES and bare platinum coil (BPC) in the new-generation Hydrogel Endovascular Aneurysm Treatment Trial (HEAT).

METHODS: HEAT is a randomized, controlled trial that enrolled subjects with ruptured or unruptured 3- to 14-mm intracranial aneurysms amenable to coiling. The primary endpoint was aneurysm recurrence using the Raymond-Roy scale. Secondary endpoints included minor and major recurrence, packing density, adverse events related to the procedure and/or device, mortality, initial complete occlusion, aneurysm retreatment, hemorrhage fromtarget aneurysm during follow-up, aneurysmocclusion stability, and clinical outcome at final follow-up.

RESULTS: A total of 600 patients were randomized (HES, n = 297 and BPC, n = 303), including 28% with ruptured aneurysms. Recurrence occurred in 11 (4.4%) subjects in the HES arm and 44 (15.4%) subjects in the BPC arm (P = .002). While the initial occlusion rate was higher with BPC, the packing density and both major and minor recurrence rates were in favor of HES. Secondary endpoints including adverse events, retreatment, hemorrhage, mortality, and clinical outcome did not differ between arms.

CONCLUSION: Coiling of small-to-medium aneurysms with second-generation HES resulted in less recurrence when compared to BPC, without increased harm. These data further support the use of the second-generation HES for the embolization of intracranial aneurysms.

 

Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation

SPINE Volume 45, Number 8, pp 493–503

Study Design. A prospective randomized controlled study.

Objective. To clarify whether percutaneous transforaminal endoscopic discectomy (PTED) has better clinical outcomes and less surgical trauma compared with microendoscopic discectomy (MED).

Summary of Background Data. Two kinds of minimally invasive spine surgeries, PTED and MED, are now widely used for the treatment of lumbar disc herniation (LDH). It is still a controversial issue to choose the proper surgical approach.

Methods. In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imagingconfirmed LDH, and were randomly allocated to PTED or MED group. The primary outcome was the score of Oswestry Disability Index (ODI) and the secondary outcomes included the score of Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, European Quality of Life-5 Dimensions, and Visual Analogue Scales for back pain and leg pain.

Results. A total of 250 participants were randomly assigned to two treatment groups, 241 of that received the specific surgical procedure. Two hundred twenty-two patients (92.1%) have completed the 2-year follow-up. Both the primary and secondary outcomes did not differ significantly between the two treatment groups at each prespecified follow-up time (P>0.05). For PTED, the postoperative improvement of ODI score in the median herniation subgroup was less compared with paramedian subgroup. For MED, less improvement of ODI score was found in far-lateral herniation subgroup compared with paramedian subgroup. Total complication rate over the course of 2 year was 13.44% in PTED group and 15.57% in MED group (P¼0.639). Ten cases (8.40%) in PTED group and five cases (4.10%) in MED group suffered from residue/recurrence of herniation, for which reoperation was required.

Conclusion. Over the 2-year follow-up period, PTED did not show superior clinical outcomes and did not appear to be safer procedure for patients with LDH compared with MED. PTED had inferior results for median disc herniation, whereas MED did not appear to be the best option for far-lateral disc herniation.

Level of Evidence: 2

Postoperative Rigid Cervical Collar Leads to Less Axial Neck Pain in the Early Stage After Open-Door Laminoplasty—A Single-Blinded Randomized Controlled Trial

Neurosurgery, Volume 85, Issue 3, September 2019, Pages 325–334

Cervical collars are used after laminoplasty to protect the hinge opening, reduce risks of hinge fractures, and avoid spring-back phenomena. However, their usemay lead to reduced range of motion and worse neck pain.

OBJECTIVE: To investigate the clinical, radiological, and functional outcomes of patients undergoing single-door laminoplasty with or without collar immobilization.

METHODS: This was a prospective, parallel, single-blinded randomized controlled trial. Patients underwent standardized single-door laminoplasty with mini-plates for cervical myelopathy and were randomly allocated into 2 groups based on the use of collar postoperatively. Clinical assessments included cervical range of motion, axial neck pain (VAS [visual analogue scale]), and objective scores (short-form 36-item, neck disability index, andmodified Japanese Orthopaedic Association). All assessmentswere performed preoperativelyandatpostoperative 1, 2, 3, and 6 wk, and 3, 6, and 12 mo. Comparative analysis was performed via analysis of variance adjusted by baseline scores, sex, and age as covariates.

RESULTS: A total of 35 patients were recruited and randomized to collar use (n = 16) and without (n = 19). There were no dropouts or complications. There were no differences between groups at baseline. Subjects had comparable objective scores and range of motion at postoperative time-points. Patientswithout collar use had higher VAS at postoperative 1 wk (5.4 vs 3.5; P = .038) and 2 wk (3.5 vs 1.5; P = .028) but subsequently follow-up revealed no differences between the 2 groups.

CONCLUSION: The use of a rigid collar after laminoplasty leads to less axial neck pain in the first 2 wk after surgery. However, there is no additional benefit with regards to range of motion, quality of life, and complication risk.

Intrathecal Morphine Following Lumbar Fusion: A Randomized, Placebo-Controlled Trial

Neurosurgery, Volume 85, Issue 2, August 2019, Pages 189–198

Despite the potential for faster postoperative recovery and the ease of direct intraoperative injection, intrathecal morphine is rarely provided in lumbar spine surgery.

OBJECTIVE: To evaluate the safety and efficacy of intrathecal morphine following lumbar fusion.

METHODS: We randomly assigned 150 patients undergoing elective instrumented lumbar fusion to receive a single intrathecal injection of morphine (0.2 mg) or placebo (normal saline) immediately prior to wound closure. The primary outcome was pain on the visual- analogue scale during the first 24 h after surgery. Secondary outcomes included respiratory depression, treatment-related side effects, postoperative opioid requirements, and length of hospital stay. An intention-to-treat, repeated-measures analysis was used to estimate outcomes according to treatment in the primary analysis.

RESULTS: The baseline characteristics of the 2 groups were similar. Intrathecal morphine reduced pain both at rest (32% area under the curves [AUCs] difference, P < .01) and with movement (22% AUCs difference, P < .02) during the initial 24 h after surgery. The risk of respiratory depression was not increased by intrathecal morphine (hazard ratio, 0.86; 95% confidence interval, 0.44 to 1.68; P = .66). Although postoperative opioid requirements were reduced with intrathecal morphine (P < .03), lengths of hospital stay were similar (P = .32). Other than a trend towards increased intermittent catheterization among patients assigned to intrathecal morphine (P = .09), treatment-related side effects did not significantly differ. The early benefits of intrathecal morphine on postoperative pain were no longer apparent after 48 h.

CONCLUSION: A single intrathecal injection of 0.2 mg of morphine safely reduces postoperative pain following lumbar fusion.

Percutaneous Interspinous Spacer vs Decompression in Patients with Neurogenic Claudication

Neurosurgery 82:621–629, 2018

Standalone interspinous process devices (IPDs) to treat degenerative lumbar spinal stenosis with neurogenic intermittent claudication (NIC) have shown ambiguous results in the literature.

OBJECTIVE: To show that a minimally invasive percutaneous IPD is safe and noninferior to standalone decompressive surgery (SDS) for patients with degenerative lumbar spinal stenosis with NIC.

METHODS: A multicenter, international, randomized, controlled trial (RCT) was conducted. One hundred sixty-three patients, enrolled at 19 sites, were randomized 1:1 to treatment with IPD or SDS and were followed for 24 mo.

RESULTS: There was significant improvement in Zurich Claudication Questionnaire physical function, as mean percentage change from baseline, for both the IPD and the SDS groups at 12 mo (primary endpoint) and 24 mo (−32.3 ± 32.1, −37.5 ± 22.8; and −37.9 ± 21.7%, −35.2 ± 22.8, both P < .001). IPD treatment was not significantly noninferior (margin: 10%) to SDS treatment at 12mo (P=.172) but was significantly noninferior at 24mo (P = .005). Symptom severity, patient satisfaction, visual analog scale leg pain, and SF-36 improved in both groups over time. IPD showed lower mean surgical time andmean blood loss (24 ± 11 min and 6 ± 11 mL) compared to SDS (70 ± 39 min and 189 ± 148 mL, both P < .001). Reoperations at index level occurred in 18.2% of the patients in the IPD group and in 9.3%in the SDS group.

CONCLUSION: Confirming 3 recent RCTs, we could show that IPD as well as open decompression achieve similar results in relieving symptoms of NIC in highly selected patients. However, despite some advantages in secondary outcomes, a higher reoperation rate for IPD is confirmed.

Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation

J Neurosurg Spine 28:300–310, 2018

A prospective randomized controlled study was conducted to clarify whether percutaneous transforaminal endoscopic discectomy (PTED) results in better clinical outcomes and less surgical trauma than microendoscopic discectomy (MED).

METHODS In this single-center, open-label, randomized controlled trial, patients were included if they had persistent signs and symptoms of radiculopathy with corresponding imaging-confirmed lumbar disc herniation. Patients were randomly allocated to the PTED or the MED group by computer-generated randomization codes. The primary outcome was the Oswestry Disability Index (ODI) score 1 year after surgery. Secondary outcomes included scores of the Medical Outcomes Study 36-Item Short-Form Health Survey bodily pain and physical function scales, EuroQol Group’s EQ-5D , and the visual analog scales for back pain and leg pain. Data including duration of operation, in-bed time, length of hospital stay, surgical cost and total hospital cost, complications, and reoperations were recorded.

RESULTS A total of 153 participants were randomly assigned to 2 treatment groups (PTED vs MED), and 89.5% (137 patients) completed 1 year of follow-up. Primary and secondary outcomes did not differ significantly between the treatment groups at each prespecified follow-up point (p > 0.05). For PTED, there was less postoperative improvement in ODI score in the median herniation subgroup at 1 week (p = 0.027), 3 months (p = 0.013), 6 months (p = 0.027), and 1 year (p = 0.028) compared with the paramedian subgroup. For MED, there was significantly less improvement in ODI score at 3 months (p = 0.008), 6 months (p = 0.028), and 1 year (p = 0.028) in the far-lateral herniation subgroup compared with the paramedian subgroup. The total complication rate over the course of 1 year was 13.75% in the PTED group and 16.44% in the MED group (p = 0.642). Five patients (6.25%) in the PTED group and 3 patients (4.11%) in the MED group suffered from residue/recurrence of herniation, for which reoperation was required.

CONCLUSIONS Over the 1-year follow-up period, PTED did not show superior clinical outcomes and did not seem to be a safer procedure for patients with lumbar disc herniation compared with MED. PTED had inferior results for median disc herniation, whereas MED did not seem to be the best treatment option for far-lateral disc herniation. Clinical trial registration no.: NCT01997086 (clinicaltrials.gov).

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.

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

Randomized Controlled Trial of Minimally Invasive Sacroiliac Joint Fusion Using Triangular Titanium Implants vs Nonsurgical Management for Sacroiliac Joint Dysfunction: 12-Month Outcomes

Pelvis-with-Implants

Neurosurgery 77:674–691, 2015

Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain.

OBJECTIVE: To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction.

METHODS: A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete.

RESULTS: Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority . 0.9999). Clinically important ($ 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P , .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31).

CONCLUSION: This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.

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

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.

Shunt surgery in patients with hydrocephalus and white matter changes

J Neurosurg 114:1432–1438, 2011. DOI: 10.3171/2010.11.JNS10967

Patients with idiopathic normal pressure hydrocephalus (iNPH) often present with impaired gait and cognition together with ventricular enlargement and normal intracranial pressure. Many have vascular risk factors as well as periventricular and deep white matter changes on MR imaging. Abnormal CSF dynamics, that is, high resistance to outflow or improvement after CSF drainage, indicate good effects of shunt surgery. The authors examined whether the worst-case iNPH patients with extensive vascular white matter disease and normal CSF dynamics would benefit from shunt surgery. These patients also fulfilled the criteria for Binswanger disease. Therefore, a randomized controlled double-blind study was performed.

Methods. Fourteen consecutive patients fulfilling the above criteria were randomized to receive either open or closed shunts. At 3 months after surgery, the patients with initially ligated shunts had their shunts opened. Clinical evaluation consisting of 7 quantitative psychometric and 6 continuous gait tests was performed preoperatively and 3 and 6 months after surgery.

Results. Patients randomized to receive open shunts had improved motor (30% increase) and psychometric (23% increase) scores 3 months after shunt placement. There were no significant changes between the 3- and 6-month follow- up in these same patients. Conversely, those with initially ligated shunts were unchanged during the first 3-month period, although they improved in both motor (28%) and cognitive (18%) functions following removal of the ligature.

Conclusions. Patients with enlarged ventricles, hydrocephalic symptoms, and extensive vascular white matter changes benefit from shunt surgery.

A systematic review of randomized trials on the effect of cervical disc arthroplasty on reducing adjacent-level degeneration

Neurosurg Focus 28 (6):E5, 2010. DOI: 10.3171/2010.3.FOCUS1032

Anterior cervical discectomy and fusion had been considered a safe and effective procedure for radiculopathy and myelopathy in the cervical spine, but degeneration in adjacent spinal levels has been a problem in some patients after fusion. Since 2002, cervical disc arthroplasty has been established as an alternative to fusion. The objective of this study was to review data concerning the role of cervical arthroplasty in reducing adjacent-level degeneration.

Methods. A systematic review was performed using the MEDLINE, EMBASE, Cochrane, and LILACS databases, focusing on a structured question involving the population of interest, types of intervention, types of control, and outcomes studied.

Results. No study has specifically compared the results of arthroplasty with the results of fusion with respect to the rate of postoperative development of adjacent-segment degenerative disease. One paper described a rate for adjacent-level surgery. The level of evidence of that paper was classified 2b, and although its authors found a statistically significant between-groups difference (arthroplasty vs fusion) using log-rank analysis, re-analysis according to number needed to treat (in the current paper) did not reveal statistical significance.

Conclusions. Adjacent-level degeneration has not been adequately studied in a review of the available randomized controlled trials on this topic, and there is no clinical evidence of reduction in adjacent-level degeneration with the use of cervical arthroplasty.

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.