Long-Term Safety and Efficacy of Minimally Invasive Lumbar Decompression Procedure for the Treatment of Lumbar Spinal Stenosis With Neurogenic Claudication

Study Design: Multicenter, prospective, randomized, and double-blinded study. Objectives: To compare tubular and endoscopic interlaminar approach. Methods: Patients with lumbar spinal stenosis and neurogenic claudication of were randomized to tubular or endoscopic technique. Enrollment period was 12 months. Clinical follow up at 1, 3, 6 months after surgery with visual analogue scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopedic Association (JOA) score. Radiologic evaluation with magnetic resonance pre- and postsurgery. Results: Twenty patients were enrolled: 10 in tubular approach (12 levels) and 10 in endoscopic approach (11 levels). The percentage of enlargement of the spinal canal was higher in endoscopic approach (202%) compared with tubular approach (189%) but was not statistically significant ( P = .777). The enlargement of the dural sac was higher in endoscopic group (209%) compared with tubular group (203%) but no difference was found between the 2 groups ( P = .628). A modest significant correlation was found between the percentage of spinal canal decompression and enlargement of the dural sac ( r = 0.5, P = .023). Both groups reported a significant clinical improvement postsurgery. However, no significant association was found between the percentage of enlargement of the spinal canal or the dural sac and clinical improvement as determined by scales scores. Endoscopic group had lower intrasurgical bleeding ( P < .001) and lower disability at 6 months of follow-up than tubular group (p=0.037). Conclusions: In the treatment of lumbar spinal stenosis, endoscopic technique allows similar decompression of the spinal canal and the dural sac, lower intrasurgical bleeding, similar symptoms improvement, and lower disability at 6 months of follow-up, as compared with the tubular technique.

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“…Both techniques show good clinical outcomes in correlation with literature. 21 -25,28 -31,37 -39,44 -48…”

Section: Discussionmentioning

confidence: 99%

Comparative Study Between Uniportal Full-Endoscopic Interlaminar and Tubular Approach in the Treatment of Lumbar Spinal Stenosis: A Pilot Study

Carrascosa-Granada

Velazquez²,

Wagner

et al. 2020

Global Spine Journal

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“…Of the remaining 27 articles, 22 were excluded because they were review articles, reports of cost-effectiveness, letters to the editor, a description of study design, or did not include a 1-year follow-up completed since 2012. Five publications met these initial criteria (Staats, 11 Benyamin, 18 Brown, 7 Deer, 8 and Mekhail 10 ). The papers by Staats and Benyamin were eliminated because they were both reports of the ENCORE study which included patients aged 65 and older only ( Figure 1).…”

Section: Included Studiesmentioning

confidence: 99%

“…Numerous studies to investigate the long-term effectiveness of the mild therapy have been performed, and all studies reported statistically significant and clinically meaningful improvement in function and reduction in pain. [7][8][9][10][11][12] A recent report of a 2-year follow-up of 99 mild patients enrolled in the ENCORE randomized controlled clinical trial described clinically meaningful and statistically significant improvement of all outcome measures through 6-month, 1-year, and 2-year follow-up. 11 A cross-disciplinary consensus group using the US Preventive Services Task Force (USPSTF) criteria for evidence level and degree of recommendation performed a systematic review of all published studies of the mild procedure, which resulted in a strong consensus for the highest recommendation of the procedure for the treatment of LSS secondary to HLF.…”

Section: Introductionmentioning

confidence: 99%

<p>The Impact of Age on the Outcomes of Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis</p>

Mekhail

Costandi

Armanyous

et al. 2020

MDER

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Background and Purpose: Minimally invasive lumbar decompression (mild ®) is an effective long-term therapy for patients with symptomatic lumbar spinal stenosis (LSS) resulting primarily from hypertrophic ligamentum flavum (HLF). Most subjects in clinical studies of the mild procedure have been older adults (age≥65). While the incidence of LSS increases with age, a substantial number of adults (age<65) also suffer from neurogenic claudication secondary to HLF. In this report, outcomes of mild were compared between adults and older adults. Patients and Methods: All prospective studies of the mild procedure with a 1-year follow-up completed since the beginning of 2012 that allowed the inclusion of adult patients of all ages were reviewed. Outcomes of visual analog scale (VAS), Oswestry Disability Index (ODI), Pain Disability Index (PDI), Roland Morris Low Back Pain and Disability Questionnaire (RMQ), standing time and walking distance were compared for adults and older adults. Results: Four studies met the inclusion criteria, resulting in an analysis of 49 adults and 160 older adults. Patients in both age groups experienced significant mean improvements in all but one outcome measure at 6-and 12-month follow-up. Differences between the two age groups in all scores at 6 and 12 months were not statistically significant. Conclusion: Analysis of the four studies indicated that symptom improvements for adults and older adults were significant from baseline, and no statistically significant difference was observed between the two age groups. These results illustrate that mild can be an effective treatment for LSS due primarily to HLF, regardless of the adult patient age.

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“… 3 LSS patients suffering from neurogenic claudication commonly present with multiple types of stenosis and numerous spinal comorbidities. 4 Therapies for these patients generally begin with conservative management, since more invasive interventions such as interspinous spacers, surgical decompression and spinal fusion are associated with higher complication rates. 4–7 Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy.…”

Section: Introductionmentioning

confidence: 99%

“… 4 Therapies for these patients generally begin with conservative management, since more invasive interventions such as interspinous spacers, surgical decompression and spinal fusion are associated with higher complication rates. 4–7 Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy. This composite first-line treatment plan may include physical therapy, home exercise programs, and pain medication, together with early interventional procedures such as epidural steroid injections, radiofrequency ablation and the mild ® Procedure (Vertos Medical, Aliso Viejo, CA, USA).…”

Section: Introductionmentioning

confidence: 99%

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial

Deer¹,

Kim²,

Wahezi³

et al. 2021

JPR

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Background Lumbar spinal stenosis (LSS) is a serious degenerative condition of the spine that can cause significant functional disability. Therapies for these patients generally begin with conservative management, since more invasive interventions such as open surgery and spinal implants are associated with higher complication rates. Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy. This composite first-line treatment plan may include conservative care together with early interventional treatment options such as epidural steroid injections, radiofrequency ablation and the mild ® Procedure. Methods This prospective randomized controlled trial evaluates patients aged 50 to 80 years treated with mild plus CMM, compared to those treated with CMM alone, as the active control. Walking tolerance test outcomes and incidence of subsequent disallowed procedures provided objective real-world outcome data. The incidence of device or procedure-related adverse events was analyzed. Follow-up includes 6-month, 1-year and 2-year assessments, with 1-year being primary. Patients in the mild +CMM group are followed at 3, 4, and 5 years. This is a report of interim 6-month outcomes. Results Of 155 patients enrolled at 19 US interventional pain management centers, 78 were allocated to CMM-Alone, and 77 to mild +CMM. At 6-months, the validated walking tolerance test demonstrated statistical superiority of mild +CMM versus CMM-Alone (p<0.001). The incidence of patients receiving a subsequent disallowed procedure, and thereby considered treatment failures in their study group, was statistically significantly higher in CMM-Alone versus mild +CMM (p<0.001). There were no device or procedure-related adverse events in either group. Conclusion At 6-months, the mild Procedure combined with CMM provided statistically superior objective real-world outcomes versus CMM-Alone. There were no device or procedure-related adverse events reported in either study group. With its excellent safety profile and superior efficacy, mild is uniquely positioned as early first-line therapy.

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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

Abstract: This study was registered at ClinicalTrials.gov, identifier NCT02093520.

Cited by 32 publications

References 26 publications

Comparative Study Between Uniportal Full-Endoscopic Interlaminar and Tubular Approach in the Treatment of Lumbar Spinal Stenosis: A Pilot Study

Comparative Study Between Uniportal Full-Endoscopic Interlaminar and Tubular Approach in the Treatment of Lumbar Spinal Stenosis: A Pilot Study

<p>The Impact of Age on the Outcomes of Minimally Invasive Lumbar Decompression for Lumbar Spinal Stenosis</p>

Objective Real-World Outcomes of Patients Suffering from Painful Neurogenic Claudication Treated with the mild® Procedure: Interim 6-Month Report of a Randomized Controlled Trial

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