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Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study.

ABSTRACT: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. At present, many spine surgeons perform microdecompression for central lumbar spinal stenosis.Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery. The primary outcome measure is change in Oswestry disability index between baseline and 12-month follow-up. Secondary outcome measures are changes in health-related quality of life measured by the Euro-Qol-5D between baseline and 12-month follow-up, perioperative complications, and duration of surgical procedures and length of hospital stay.The study has been evaluated and approved by the regional committee for medical research in central Norway and all participants provided written informed consent. The findings of this study will be disseminated through peer-reviewed publications.Clinicaltrials.gov (NCT02006901).

SUBMITTER: Nerland US

PROVIDER: S-EPMC3963092 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study.

Nerland Ulf S US Jakola Asgeir S AS Solheim Ole O Weber Clemens C Rao Vidar V Lønne Greger G Solberg Tore K TK Salvesen Oyvind O Carlsen Sven M SM Nygaard Oystein P OP Gulati Sasha S

BMJ open 20140320 3

<h4>Introduction</h4>This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often ...[more]

PMID: 24650809

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Project description:ObjectiveTo test the equivalence for clinical effectiveness between microdecompression and laminectomy in patients with central lumbar spinal stenosis.DesignMulticentre observational study.SettingProspective data from the Norwegian Registry for Spine Surgery.Participants885 patients with central stenosis of the lumbar spine who underwent surgery at 34 Norwegian orthopaedic or neurosurgical departments. Patients were treated from October 2006 to December 2011.InterventionsLaminectomy and microdecompression.Main outcome measuresThe primary outcome was change in Oswestry disability index score one year after surgery. Secondary endpoints were quality of life (EuroQol EQ-5D), perioperative complications, and duration of surgical procedures and hospital stays. A blinded biostatistician performed predefined statistical analyses in unmatched and propensity matched cohorts.ResultsThe study was powered to detect a difference between the groups of eight points on the Oswestry disability index at one year. 721 patients (81%) completed the one year follow-up. Equivalence between microdecompression and laminectomy was shown for the Oswestry disability index (difference 1.3 points, 95% confidence interval -1.36 to 3.92, P<0.001 for equivalence). Equivalence was confirmed in the propensity matched cohort and full information regression analyses. No difference was found between groups in quality of life (EQ-5D) one year after surgery. The number of patients with complications was higher in the laminectomy group (15.0% v 9.8%, P=0.018), but after propensity matching for complications the groups did not differ (P=0.23). The duration of surgery for single level decompression was shorter in the microdecompression group (difference 11.2 minutes, 95% confidence interval 4.9 to 17.5, P<0.001), but after propensity matching the groups did not differ (P=0.15). Patients in the microdecompression group had shorter hospital stays, both for single level decompression (difference 1.5 days, 95% confidence interval 1.7 to 2.6, P<0.001) and two level decompression (0.8 days, 1.0 to 2.2, P=0.003).ConclusionAt one year the effectiveness of microdecompression is equivalent to laminectomy in the surgical treatment of central stenosis of the lumbar spine. Favourable outcomes were observed at one year in both treatment groups.Trial registration ClinicalTrials.gov NCT02006901.

Project description:ImportanceConflicting evidence and large practice variation are present in the surgical treatment of degenerative spondylolisthesis. More than 90% of surgical procedures in the United States include instrumented fusion compared with 50% or less in other countries.ObjectiveTo evaluate whether the effectiveness of microdecompression alone is noninferior to decompression with instrumented fusion in a real-world setting.Design, setting, and participantsThis multicenter comparative effectiveness study with a noninferiority design assessed prospective data from the Norwegian Registry for Spine Surgery. From September 19, 2007, to December 21, 2015, 1376 patients at 35 Norwegian orthopedic and neurosurgical departments underwent surgery for lumbar spinal stenosis with degenerative spondylolisthesis without scoliosis. After excluding patients undergoing laminectomy alone, fusion without instrumentation, or surgery in more than 2 levels and those with a former operation at the index level, 794 patients were included in the analyses, regardless of missing or incomplete follow-up data, before propensity score matching. Data were analyzed from March 20 to October 30, 2018.ExposuresMicrodecompression alone or decompression with instrumented fusion.Main outcomes and measuresA reduction from baseline of 30% or greater in the Oswestry Disability Index at 12-month follow-up.ResultsAfter propensity score matching, 570 patients (413 female [72%]; mean [SD] age, 64.7 [9.5] years) were included for comparison, with 285 undergoing microdecompression (mean [SD] age, 64.6 [9.8] years; 205 female [72%]) and 285 undergoing decompression with instrumented fusion (mean [SD] age, 64.8 [9.2] years; 208 female [73%]). The proportion of each type of procedure varied between departments. However, changes in outcome scores varied within patients but not between departments. The proportion of patients with improvement in the Oswestry Disability Index of at least 30% was 150 of 219 (68%) in the microdecompression group and 155 of 215 (72%) in the instrumentation group. The 95% CI (-12% to 5%) for the difference of -4% was above the predefined margin of noninferiority (-15%). Microdecompression alone was associated with shorter operation time (mean [SD], 89 [44] vs 180 [65] minutes; P < .001) and shorter hospital stay (mean [SD], 2.5 [2.4] vs 6.4 [3.0] days; P < .001).Conclusions and relevanceAmong patients with degenerative spondylolisthesis, the clinical effectiveness of microdecompression alone was noninferior to that of decompression with instrumented fusion. Microdecompression alone was also associated with shorter durations of surgery and hospital stay, supporting the suggestion that the less invasive procedure should be considered for most patients.

Project description:Study designSecondary analysis of a randomized controlled trial.ObjectiveTo identify preoperative physical variables associated with favorable postoperative outcome in individuals undergoing laminectomy or laminotomy for degenerative central lumbar spinal stenosis.Summary of background dataClinical or condition specific variables have most commonly been studied as predictors of postoperative outcome in lumbar spinal stenosis. If associated to favorable postoperative outcome, modifiable physical variables would inform prehabilitation interventions for patients with degenerative central lumbar spinal stenosis.MethodsPatients awaiting surgery for central lumbar spinal stenosis were recruited to participate in a randomized controlled trial. Following baseline data collection of demographics, clinical portrait and physical testing, participants were randomized to either 6-week active prehabilitation program or hospital standard care. Complete baseline and postoperative data were obtained from 58 participants which were included in the present analysis. Favorable postoperative outcome was determined based on two outcome measures. Favorable outcome was defined as a decrease of ≥30% on the Numerical Rating Scale for leg pain intensity and a decrease of ≥30% on the Oswestry Disability Index for low back disability. Baseline physical variables were used to conduct binary logistic regression.ResultsSixty percent of participants were determined as having a favorable postoperative outcome. None of the included physical variables were found to be predictors of a favorable postoperative outcome based on leg pain intensity and low back pain-associated disability [trunk flexors muscle strength (OR = 0.73; 95%CI (0.02-27.12)] lumbar extensors muscle endurance [OR= 1.09; 95%CI (0.95-1.24)] total ambulation time [OR = 1.00 95%CI (0.99-1.01)] lumbar active range of motion in extension [OR = 1.08; 95%CI (0.95-1.23)] and knee extensors muscle strength [OR=1.02; 95%CI (0.98-1.06)].ConclusionResults show that none of the investigated variables, all related to low back and lower limbs physical capacity, were predictors of postoperative recovery. Further testing in larger cohort is needed to assess the full potential of physical outcome measures as predictors of postoperative recovery.

Project description:INTRODUCTION:Lumbar spinal stenosis is a common cause of low back and leg pain in the elderly and affects both physical activity and quality of life. First-line treatments are non-surgical options but if unsuccessful, surgery is advocated. The literature is not clear as to the outcome of surgery compared with non-surgical treatment, and the optimal time for surgery is not explicit. This observational study is designed to investigate the course of treatment, compare effectiveness of surgical and non-surgical management in patients with lumbar spinal stenosis and identify prognostic factors for outcome in the context of current clinical practice. MATERIALS AND ANALYSIS:Prospectively registered data on treatment, outcome and patient characteristics are collected from nationwide registers on health and social issues, a clinical registry of people with chronic back pain and hospital medical records. Primary outcome is change in physical function measured by the Zurich Claudication Questionnaire. Secondary outcomes are changes in symptom severity, pain-related function, health-related quality of life and general self-efficacy. Outcomes are assessed at baseline and 6 and 12 months. Outcomes at 12 months will be compared for patients who undergo surgery for lumbar spinal stenosis and patients managed non-surgically, using different analytical approaches. Prespecified prognostic factors of interest at baseline include treatment allocation, back and leg pain intensity, comorbidity, duration of symptoms, pretreatment function, self-rated health, income, general self-efficacy and MRI-graded severity of central stenosis. ETHICS AND DISSEMINATION:The study has been evaluated by the Regional Committees on Health Research for Southern Denmark (S-20172000-200) and notified to the Danish Data Protection Agency (18/22336). All participants provide consent. Findings will be disseminated in peer-reviewed publications and presented at national and international conferences according to the Strengthening the Reporting of Observational Studies in Epidemiology and Prognosis Research Strategy statements. Potential sources of bias will be addressed using Risk of Bias in Non-randomised Studies of Interventions. TRIAL REGISTRATION NUMBER:NCT03548441; Pre-results.

Project description:Retrospective cohort.To identify factors that were independently associated with increased postoperative length of stay (LOS) and readmission in patients who underwent elective laminectomy for lumbar spinal stenosis.Lumbar spinal stenosis is a common pathology that is traditionally treated with decompressive laminectomy. Risk factors associated with increased LOS and readmission have not been fully characterized for laminectomy.Patients who underwent laminectomy for lumbar spinal stenosis during 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database. Patient characteristics were tested for association with LOS and readmission using bivariate and multivariate analyses. Patients with LOS more than 10 days were excluded from the readmission analysis as the American College of Surgeons National Surgical Quality Improvement Program only captures readmissions within 30 postoperative days, and the window for potential readmission was deemed too short for patients staying longer than 10 days.A total of 2358 patients who underwent laminectomy met inclusion criteria. The average age was 66.4 ± 11.7 years (mean ± standard deviation). Average postoperative LOS was 2.1 ± 2.6 days. Of those meeting criteria for readmission analysis, 3.7% of patients (86 of 2339) were readmitted within 30 days postoperatively.Independent risk factors for prolonged LOS were increased age (P < 0.001), increased body mass index (P = 0.004), American Society of Anesthesiologists class 3-4 (P = 0.005), and preoperative hematocrit less than 36.0 (P = 0.001). Independent risk factors for readmission were increased age (P = 0.013), increased body mass index (P = 0.040), American Society of Anesthesiologists class 3-4 (P < 0.001), and steroid use (P = 0.001). The most common reason for readmission was surgical site-related infections (25.0% of patients readmitted in 2012).The identified factors associated with LOS and readmission after lumbar laminectomy may be useful for optimizing patient care.

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Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study.

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Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: study protocol for an observational study.

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