Tubular discectomy versus conventional microdiscectomy for the treatment of lumbar disc herniation: long-term results of a randomised controlled trial.

BACKGROUND: The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy. METHODS: The study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randomly allocated to tubular discectomy (166 patients) or conventional microdiscectomy (159 patients). Repeated standardised follow-up measurements were performed at 2, 4, 6, 8, 12, 26, 38, 52, 78, 104, 156, 208 and 260 weeks after randomisation. Main outcomes are the Roland-Morris Disability Questionnaire for Sciatica (RDQ), Visual Analogue Scale for leg pain and low back pain, self-perceived recovery and reoperation incidence. RESULTS: There was no clinically significant difference between tubular discectomy and conventional microdiscectomy regarding the main clinical outcomes at any time point during the 5 years of follow-up. RDQ scores at 5 years were 4.3 (95% CI 3.3 to 5.2) in the tubular discectomy group and 3.4 (95% CI 2.4 to 4.5) in the conventional microdiscectomy group. The mean difference of 0.9 (95% CI -0.6 to 2.2) was not significant. Mean differences for leg pain and back pain were 0.2 (95% CI -5.5 to 6.0) and 0.4 (95% CI -5.9 to 6.7), respectively. 77% of patients allocated to conventional discectomy reported complete or near-complete recovery of symptoms compared with 74% of patients allocated to tubular discectomy (p=0.79). The reoperation rate was 18% in the tubular discectomy group and 13% in the conventional discectomy group (p=0.29). CONCLUSIONS: Long-term functional and clinical outcome did not differ between patients allocated to tubular discectomy and conventional microdiscectomy. Primary and secondary outcome measures did not support the hypothesised advantages of tubular discectomy over conventional microdiscectomy. TRIAL REGISTRATION NUMBER: ISRCTN51857546.

Effectiveness of posterior decompression techniques compared with conventional laminectomy for lumbar stenosis.

BACKGROUND: The gold standard treatment for symptomatic lumbar stenosis refractory to conservative management is a facet-preserving laminectomy. New techniques of posterior decompression have been developed to preserve spinal integrity and to minimise tissue damage by limiting bony decompression and avoiding removal of the midline structures (i.e. spinous process, vertebral arch and interspinous and supraspinous ligaments). OBJECTIVES: To compare the effectiveness of techniques of posterior decompression that limit the extent of bony decompression or avoid removal of posterior midline structures of the lumbar spine versus conventional facet-preserving laminectomy for the treatment of patients with degenerative lumbar stenosis. SEARCH METHODS: An experienced librarian conducted a comprehensive electronic search of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Web of Science, and the clinical trials registries ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) for relevant literature up to June 2014. SELECTION CRITERIA: We included prospective controlled studies comparing conventional facet-preserving laminectomy versus a posterior decompressive technique that avoids removal of posterior midline structures or a technique involving only partial resection of the vertebral arch. We excluded studies describing techniques of decompression by means of interspinous process devices or concomitant (instrumented) fusion procedures. Participants included individuals with symptomatic degenerative lumbar stenosis only. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias using the Cochrane Back Review Group criteria for randomised controlled trials (RCTs) and the Newcastle-Ottawa Scale for non-randomised studies. We extracted data regarding demographics, intervention details and outcome measures. MAIN RESULTS: A total of four high-quality RCTs and six low-quality RCTs met the search criteria of this review. These studies included a total of 733 participants. Investigators compared three different posterior decompression techniques versus conventional laminectomy. Three studies (173 participants) compared unilateral laminotomy for bilateral decompression versus conventional laminectomy. Four studies (382 participants) compared bilateral laminotomy versus conventional laminectomy (one study included three treatment groups and compared unilateral and bilateral laminotomy vs conventional laminectomy). Finally, four studies (218 participants) compared a split-spinous process laminotomy versus conventional laminectomy.Evidence of low or very low quality suggests that different techniques of posterior decompression and conventional laminectomy have similar effects on functional disability and leg pain. Only perceived recovery at final follow-up was better in people who underwent bilateral laminotomy compared with conventional laminectomy (two RCTs, 223 participants, odds ratio 5.69, 95% confidence interval (CI) 2.55 to 12.71).Among the secondary outcome measures, unilateral laminotomy for bilateral decompression and bilateral laminotomy resulted in numerically fewer cases of iatrogenic instability, although in both cases, the incidence of instability was low (three RCTs, 166 participants, odds ratio 0.28, 95% CI 0.07 to 1.15; three RCTs, 294 participants, odds ratio 0.10, 95% CI 0.02 to 0.55, respectively). The difference in severity of postoperative low back pain following bilateral laminotomy (two RCTs, 223 participants, mean difference -0.51, 95% CI -0.80 to -0.23) and split-spinous process laminotomy compared with conventional laminectomy (two RCTs, 97 participants, mean difference -1.07, 95% CI -2.15 to -0.00) was significantly less, but was too small to be clinically important. A quantitative comparison between unilateral laminotomy and conventional laminectomy was not possible because of different reporting of outcome measures. We found no evidence to show that the incidence of complications, length of the procedure, length of hospital stay and postoperative walking distance differed between techniques of posterior decompression. AUTHORS' CONCLUSIONS: The evidence provided by this systematic review for the effects of unilateral laminotomy for bilateral decompression, bilateral laminotomy and split-spinous process laminotomy compared with conventional laminectomy on functional disability, perceived recovery and leg pain is of low or very low quality. Therefore, further research is necessary to establish whether these techniques provide a safe and effective alternative for conventional laminectomy. Proposed advantages of these techniques regarding the incidence of iatrogenic instability and postoperative back pain are plausible, but definitive conclusions are limited by poor methodology and poor reporting of outcome measures among included studies. Future research is necessary to establish the incidence of iatrogenic instability using standardised definitions of radiological and clinical instability at comparable follow-up intervals. Long-term results with these techniques are currently lacking.

Management of lumbar spinal stenosis: a survey among Dutch spine surgeons.

BACKGROUND: Various surgical and non-surgical treatments for lumbar spinal stenosis (LSS) are widely adopted in clinical practice, but high quality randomised controlled trials to support these are often lacking, especially in terms of their relative benefit and risk compared with other treatment options. Therefore, an evaluation of agreement among clinicians regarding the indications and the choice for particular treatments seems appropriate. METHODS: One hundred and six Dutch neurosurgeons and orthopaedic spine surgeons completed a questionnaire, which evaluated treatment options for LSS and expectations regarding the effectiveness of surgical and non-surgical treatments. RESULTS: Responders accounted for 6,971 decompression operations and 831 spinal fusion procedures for LSS annually. Typical neurogenic claudication, severe pain/disability, and a pronounced constriction of the spinal canal were considered the most important indications for surgical treatment by the majority of responders. Non-surgical treatment was generally regarded as ineffective and believed to be less effective than surgical treatment. Interlaminar decompression was the preferred technique by 68% of neurosurgeons and 52% orthopaedic surgeons for the treatment of LSS. Concomitant fusion was applied in 12% of all surgery for LSS. Most surgeons considered spondylolisthesis as an indication and spinal instability as a definite indication for additional fusion. CONCLUSIONS: The current survey demonstrates a wide variety of preferred treatments of symptomatic LSS by Dutch spine surgeons. To minimise variety, national and international protocols based on high-quality randomised controlled trials and systematic reviews are necessary to give surgeons more tools to support everyday decision-making.

Aspin: neurosurgical aspirin intervention prognostic study - perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial.

RATIONALE: Aspirin is typically discontinued in cranial and spinal surgery because of the increased risk of hemorrhagic complications, but comes together with the risk of resulting in an increase of cardiac and neurologic thrombotic perioperative events. OBJECTIVE: The aim of this study is to investigate the non-inferiority of perioperative continuation of aspirin patients undergoing low complex lumbar spinal surgery, compared with the current policy of perioperative discontinuation of aspirin. STUDY DESIGN: A randomized controlled trial with two parallel groups of 277 cases (554 in total). STUDY POPULATION: Patients undergoing low complex lumbar spinal surgery and using aspirin. All patients are aged >18 years. INTERVENTION: Peri-operative continuation of aspirin. STUDY OUTCOMES: Primary study outcome: composite of the following bleeding complications: Neurological deterioration as a result of hemorrhage in the surgical area with cauda and/or nerve root compression. Post-surgical anemia with hemoglobin level lower than 5 mmol/l, requiring transfusion. Subcutaneous hematoma leading to wound leakage and pain higher than NRS=7. Major and/or minor hemorrhage in any other body system according to the definition of the International Society on Thrombosis and Haemostasis bleeding scale. Secondary study outcomes: Each of the individual components of the primary outcome Absolute mean difference in operative blood loss between the study arms Thrombo-embolic-related complications: Myocardial infarction Venous thromboembolism Stroke Arterial thromboembolism FURTHER STUDY OUTCOMES: Anticoagulant treatment satisfaction by the Anti-Clot Treatment Scale (ACTS) and general health by the Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) in the pre- and postoperative phase. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study imposes no additional risk to patients. Currently, there is no consensus on whether or not aspirin should be discontinued before cranial or spinal surgery. Currently, aspirin is typically discontinued in cranial and spinal surgery, because of a potential increased risk of hemorrhagic complication. An argument not based on a clinical trial. However, this policy might delay surgical procedures or carry the risk of resulting in an increase in cardiac and neurologic thrombotic perioperative events. It is unclear if the possibility of an increase in hemorrhage-related complications outweighs the risk of an increase in cardiac and neurologic thrombotic perioperative events. Furthermore, the Data Safety Monitoring Board (DSMB) will be asked for safety analysis by monitoring the study. There are no further disadvantages to participating in this study. Outcome measurements are recorded during admission and regular outpatient visits, and thus, do not require additional visits to the hospital.

Design of the Verbiest trial: cost-effectiveness of surgery versus prolonged conservative treatment in patients with lumbar stenosis.

BACKGROUND: Degenerative changes of lumbar spine anatomy resulting in the encroachment of neural structures are often regarded progressive, ultimately necessitating decompressive surgery. However the natural course is not necessarily progressive and the efficacy of a variety of nonsurgical interventions has also been described. At present there is insufficient data to compare surgical and nonsurgical interventions in terms of their relative benefit and safety. Previous attempts failed to provide clear clinical recommendations or to distinguish subgroups that substantially benefit from a certain treatment strategy. We present the design of a randomized controlled trial on (cost-) effectiveness of surgical decompression versus prolonged conservative treatment in patients with neurogenic intermittent claudication caused by lumbar stenosis. METHODS/DESIGN: The aim of the Verbiest trial is to evaluate the effectiveness of prolonged conservative treatment compared to decompressive surgery. The study is a multi-center randomized controlled trial with two parallel groups design. Patients (age over 50) presenting to the neurologist or neurosurgeon with at least 3 months complaints of neurogenic intermittent claudication and considering surgical treatment are eligible for inclusion. Participants are randomly allocated to either prolonged conservative treatment, receiving further treatment from their general practitioner and physical therapist, or allocated to surgery and operated within 4 weeks. Primary outcome measure is the functional assessment of the patient as measured by the Zurich Claudication Questionnaire at 24 months of follow-up. Data is analyzed according to the intention to treat principle. DISCUSSION: With a cost-effectiveness analysis the trade off between the costs of prolonged conservative treatment and delayed surgery in a smaller number of patients are compared with the current policy of surgical management. As surgery is expected to be inevitable in certain subgroups of patients, the distinction of and classification by predictive patient characteristics is most relevant to clinical practice. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR2216.

Recovery of motor deficit accompanying sciatica--subgroup analysis of a randomized controlled trial.

BACKGROUND CONTEXT: In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit. PURPOSE: The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment. STUDY DESIGN: Subgroup analysis of a randomized controlled trial. PATIENT SAMPLE: This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit. OUTCOME MEASURES: Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale. METHODS: In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague. RESULTS: Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p=.01), but the difference was no longer significant at 26 (p=.21) or 52 weeks (p=.92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing ≥25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year. CONCLUSIONS: Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year.

Diagnosis of lumbar spinal stenosis: an updated systematic review of the accuracy of diagnostic tests.

STUDY DESIGN: Systematic review of diagnostic studies. OBJECTIVE: To update our previous systematic review on the diagnostic accuracy of tests used to diagnose lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: A wide range of clinical, radiological, and electrodiagnostic tests are used to diagnose lumbar spinal stenosis. An accurate diagnosis is vital, because lumbar spinal stenosis may require specific medical advice and treatment. Therefore, it is important to know the accuracy of these diagnostic tests currently available. METHODS: A comprehensive literature search was conducted for original diagnostic studies on lumbar spinal stenosis, in which one or more diagnostic tests were evaluated with a reference standard, and diagnostic accuracy was reported or could be calculated. Our previous systematic review included studies up to March 2004; this review is current up to March 2011. Included studies were assessed for their methodological quality using the QUADAS tool. Study characteristics and reported diagnostic accuracy were extracted. RESULTS: Twenty-two additional articles in addition to the 24 included in the previous review met the inclusion criteria. Combined, this resulted in 20 articles concerning imaging tests, 11 articles evaluating electrodiagnostic tests, and 15 articles evaluating clinical tests. Estimates of the diagnostic accuracy of the tests differed considerably. CONCLUSION: There is a need for a consensus on criteria to define and classify lumbar spinal stenosis. At present, the most promising imaging test for lumbar spinal stenosis is magnetic resonance imaging, avoiding myelography because of its invasiveness and lack of superior accuracy. Electrodiagnostic studies showed no superior accuracy for conventional electrodiagnostic testing compared with magnetic resonance imaging. These tests should be considered in the context of those presenting symptoms with the highest diagnostic value, including radiating leg pain that is exacerbated while standing up, the absence of pain when seated, the improvement of symptoms when bending forward, and a wide-based gait.