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Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE.

ABSTRACT: BACKGROUND AND OBJECTIVES:This study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients. METHODS:This prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events. RESULTS:All outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event. CONCLUSIONS:MILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum. CLINICAL TRIAL REGISTRATION:This study was registered at ClinicalTrials.gov, identifier NCT02093520.

SUBMITTER: Staats PS

PROVIDER: S-EPMC6319572 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE.

Staats Peter S PS Chafin Timothy B TB Golovac Stanley S Kim Christopher K CK Li Sean S Richardson William B WB Vallejo Ricardo R Wahezi Sayed E SE Washabaugh Edward P EP Benyamin Ramsin M RM

Regional anesthesia and pain medicine 20181001 7

<h4>Background and objectives</h4>This study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients.<h4>Methods</h4>This prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with M ...[more]

PMID: 30199512

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Project description:BACKGROUND:One advantage of an endoscopic approach to treating lumbar spinal stenosis is preservation of spine stability and the adjacent anatomy, and there is a decrease in adjacent segment disc degeneration. The purpose of this study was to discuss the clinical efficacy of percutaneous transforaminal endoscopic decompression for the treatment of lumbar spinal stenosis (LSS). METHODS:This is a retrospective study. From September 2012 to June 2017, 45 patients who were diagnosed with LSS underwent the treatment of percutaneous transforaminal endoscopic decompression (PTED) and were followed up at 1 week, 3 months and 1 year postoperatively. Low back pain and leg pain were measured by Visual Analogue Scale scoring methods (VAS-back and VAS-leg), while functional outcomes were assessed by using the Oswestry Disability Index (ODI). All patients had one-level lumbar spinal stenosis. RESULTS:The most common type of stenosis was lateral recess stenosis (n?=?22; 48.9%), followed by central stenosis (n?=?13; 28.9%) and foraminal stenosis (n?=?10: 22.2%). Regarding comparisons of VAS-back, VAS-leg, and ODI scores before and after operation, VAS and ODI scores significantly improved. The average leg VAS score improved from 7.01?±?0.84 to 2.28?±?1.43 (P?<?0.001). The average ODI improved from 46.18?±?10.11 to 14.40?±?9.59 (P?<?0.001). We also examined changes in ODI and VAS scores from baseline according to types of spinal stenosis, stenosis grade, spinal instability, and revision surgery in the same segment. The improvement percentage of leg VAS score was significantly less in patients with severe stenosis at both 3 months and 1 year postoperatively. The improvement percentages of ODI and leg VAS scores were significantly less in patients who had spinal instability and patients who had undergone revision surgery. CONCLUSION:The PTED approach seems to give good results for the treatment of LSS. However, this approach may be less effective for LSS patients who have lumbar instability or require revision surgery in the same segment.

Project description:Study designCase-control study.PurposeIn this study, we aimed to investigate clinical outcomes and morphological features in elderly patients with lumbar spinal stenosis (LSS) who were treated by minimally invasive surgery (MIS) unilateral laminectomy for bilateral decompression (ULBD) using a tubular retractor.Overview of literatureNumerous methods using imaging have been attempted to describe the severity of spinal stenosis. But the relationship between clinical symptoms and radiological features remains debatable.ObjectiveIn this study, we aimed to investigate clinical outcomes and morphological features in elderly patients with LSS who were treated by MIS-ULBD.MethodsWe methodically assessed 85 consecutive patients aged >65 years who were treated for LSS. The patients were retrospectively analyzed in two age groups: 66-75 years (group 1) and >75 years (group 2). Clinical outcomes were assessed using the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and the modified MacNab criteria. Outcome parameters were compared between the groups at the 1-year follow-up. Core radiologic parameters for central and lateral stenosis were analyzed and clinical findings of the groups were compared.ResultsAt the 1-year follow-up, patients in both groups 1 and 2 demonstrated significant improvement in their VAS and ODI scores. All clinical outcomes, except postoperative ODI, were not significantly difference between the groups. In addition, no significant difference was noted in the preoperative radiological parameters between the groups. There was no statistically significant correlation between radiological parameters and clinical symptoms or their outcomes. Moreover, no differences were noted in perioperative adverse events and in the need for repeat surgery at follow-ups between the groups.ConclusionsMIS-ULBD by tubular approach is a safe and effective treatment option for elderly patients with LSS. Clinical outcomes in patients with LSS and aged >75 years were comparable with those in patients with LSS and aged 66-75 years. Moreover, we did not find any correlation between radiological parameters and clinical outcomes in either of the two patient groups.

Project description:Background:The indications of different endoscopic and endoscopically assisted translaminar approaches for lumbar spinal stenosis are not well-defined, and validated protocols for the use of the transforaminal over the interlaminar approach are lacking. Methods:We performed a retrospective study employing an image-based patient stratification protocol of stenosis location (type I-central canal, type II-lateral recess, type III-foraminal, type IV-extraforaminal) and clinical outcomes on 249 patients consisting of 137 (55%) men and 112 (45%) women with an average age of 56.03±16.8 years who underwent endoscopic surgery for symptomatic spinal stenosis from January 2013 to February 2019. The average follow-up of 38.27±27.9 months. The primary clinical outcome measures were the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and modified Macnab criteria. Results:The frequency of stenosis configuration in decreasing order was as follows: type I-121/249; 48.6%, type III-104/249; 41.8%, type II-15/249; 6%, and type IV-9/249; 3.6%. The transforaminal approach (137/249; 55.0%) was used in most type II to IV lesions followed by the interlaminar approach (78/249; 31.3%), and the full endoscopic approach (12/249; 4.8%), and the endoscopically assisted translaminar approach (8/249; 3.2%) which was exclusively used for type I lesions. Macnab outcomes analysis showed Excellent in 47 patients (18.9%), Good in 178 (71.5%), Fair in 18 (7.2%) and Poor in 6 (2.4%), respectively. Paired two-tailed t-test showed statistically significant VAS (5.46±2.1; P<0.0001) and ODI (37.1±16.9; P<0.0001) reductions as a result of the endoscopic decompression surgery. Cross-tabulation of the Macnab outcomes versus the endoscopic approach and surgical technique confirmed beneficial association of the approach selection with Excellent (P=0.001) and Good (P<0.0001) outcomes with statistically significance. Conclusions:This study suggests that in the hands of skilled endoscopic spines surgeon use of an image-based stenosis location protocol may contribute to obtaining Excellent and Good clinical outcomes in a high percentage (93%) of patients suffering from lumbar stenosis related radiculopathy. Additional comparative studies should examine the prognostic value of choosing the endoscopic approach on the basis of the proposed four-type stenosis protocol by correlating its impact on outcomes with preoperative diagnostic injections and intraoperative direct visualization of symptomatic pain generators under local anesthesia and sedation.

Dataset Information

Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE.

Publications

Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication: 2-Year Results of MiDAS ENCORE.

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