scholarly journals New Image-Guided Ultra-Minimally Invasive Lumbar Decompression Method: The mild® Procedure

2010 ◽  
Vol 1;13 (1;1) ◽  
pp. 35-41
Author(s):  
Timothy R. Deer

Background and Objectives: Lumbar canal stenosis is a common source of chronic low back and leg pain. Minimally Invasive Lumbar Decompression (mild®) is a new minimally invasive treatment for pain relief from symptomatic central lumbar canal stenosis. The procedure involves limited percutaneous laminotomy and thinning of the ligamentum flavum in order to increase the critical diameter of the stenosed spinal canal. The objective of this technical report is to evaluate the acute safety of the mild procedure. Methods: Manual and electronic chart survey was conducted by 14 treating physicians located in 9 U.S. states on 90 consecutive patients who underwent the mild procedure. Patients within local geographical practice areas were selected in keeping with product Instructions For Use. Those patients requiring lumbar decompression via tissue resection at the perilaminar space, within the interlaminar space and at the ventral aspect of the lamina were treated. Data collected included any complications and/or adverse events occurring during or immediately following the procedure prior to discharge. Results: Of 90 procedures reviewed, there were no major adverse events or complications related to the devices or procedure. No incidents of dural puncture or tear, blood transfusion, nerve injury, epidural bleeding, or hematoma were observed. Limitations: Data were not specifically collected; however, regardless of difficulty, in this series none of the procedures were aborted and none resulted in adverse events. Efficacy parameters were not collected in this safety survey. Conclusions: This review demonstrates the acute safety of the mild procedure with no report of significant or unusual patient complications. To establish complication frequency and longer-term safety profile associated with the treatment, additional studies are currently being conducted. Survey data on file at Vertos Medical, Inc. Key words: Spine, decompression, fluoroscopy, mild, stenosis, ligamentum

Spine ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Sunao Tanaka ◽  
Kanichiro Wada ◽  
Gentaro Kumagai ◽  
Toru Asari ◽  
Shuichi Aburakawa ◽  
...  

2019 ◽  
Vol 16 (1) ◽  
pp. 62-71
Author(s):  
Dustin H. Massel ◽  
Benjamin C. Mayo ◽  
Dil V. Patel ◽  
Daniel D. Bohl ◽  
Philip K. Louie ◽  
...  

2021 ◽  
Vol 0 (0) ◽  
pp. 0-0
Author(s):  
James R. Onggo ◽  
Mithun Nambiar ◽  
Julian T. Maingard ◽  
Kevin Phan ◽  
Stefano Marcia ◽  
...  

2010 ◽  
Vol 6;13 (6;12) ◽  
pp. 555-560
Author(s):  
Jay S Grider

Background: Lumbar spinal stenosis and neurogenic claudication functionally impact thousands of patients per year. Those who fail conservative therapies and are not surgical candidates due to co-morbid conditions have few interventional options available. The recently described mild® procedure (Minimally Invasive Lumbar Decompression) is a candidate to fill this void. While 2 studies have reported no major adverse events with this procedure, the typical post-procedure patient course has not been previously described. Objective: To examine the minor adverse events and periprocedural course associated with mild. Additionally, to evaluate the efficacy of the procedure with regard to pain relief and functional status. Design: Retrospective evaluation. Methods: Forty-two consecutive patients meeting magnetic resonance imaging (MRI) criteria for mild underwent the procedure performed by 2 interventional pain management physicians working at the same center. The pre and post procedure visual analog scale (VAS) as well as markers of global function were recorded. Major and minor adverse events were tracked and patient outcomes reported. Results: There were no major adverse events reported. Of the minor adverse events, soreness lasting 3.8 days was most frequently reported. No patients required overnight observation and only 5 required postoperative opioid analgesics. Patients self-reported improvement in function as assessed by ability to stand and ambulate for greater than 15 minutes, whereas prior to the procedure 98% reported significant limitations in these markers of global functioning. Visual analog pain scores were significantly decreased by 40% from baseline. Eighty-six percent of the patients reported that they would recommend the mild procedure to others. Conclusions: The mild procedure appears to be a safe and likely effective option for treatment of neruogenic claudication in patients who have failed conservative therapy and have ligamentum flavum hypertrophy as the primary distinguishing component of the stenosis. Key words: Minimally invasive lumbar decompression, lumbar spinal stenosis, neurogenic claudication, fluoroscopy, ligamentum flavum


2021 ◽  
Vol 20 (3) ◽  
pp. 189-191
Author(s):  
AJAY KUMAR SHETTY PAPANNA ◽  
SUJITH RAO VITTALDAS ◽  
BALAMURUGAN THIRUGNANAM ◽  
VIDYADHARA SRINIVASA

ABSTRACT Objective To study the role of epidural steroid injection (ESI) in patients with lumbar disc herniation (LDH) and lumbar canal stenosis (LCS). ESIs are regularly used to support non-operative treatment for LBP, and our anecdotal impression is that a considerable proportion of patients report substantial pain relief after ESI. Methods One thousand consecutive patients (645 patients with LDH and 355 patients with LCS) who required ESI from January-August 2018 were included. All were given the same ESI, prepared with triamcinolone (80 mg), bupivacaine (0.25%, 4 ml) and normal saline (4 ml). Patients were evaluated using the numerical rating scale (NRS) immediately after the injection, after 7 days, and after 3 months. Results The mean NRS back-pain score of the LDH-group was reduced from 5 (range: 4-8) to 4 (range: 2-7) immediately after injection, 2 (range: 1-7) after 7 days and 2 (range: 1-7) after 3 months (p-value<0.001). The mean NRS back-pain score of the LCS-group was reduced from 5 (range: 4-8) to 4 (range: 2-7) immediately after injection, 2 (range: 1-7) after 7 days and 3 (range: 1-7) after 3 months (p-value <0.001). The mean NRS leg-pain score of the LDH group was reduced from 5 (range: 4-9) to 3 (range: 3-7) immediately after injection, 1 (range: 1-6) after 7 days and 2 (range: 1-7) after 3 months (p-value <0.001). The mean NRS leg-pain score of the LCS group was reduced from 5 (range: 4-9) to 4 (range: 3-7) immediately after injection, 3 (range: 1-7) after 7 days and 2 (range 1-6) after 3 months (p-value <0.001). Conclusion ESI causes statistically significant improvement in back and leg pain in patients with LDH and LCS. However, the short and medium-term efficacy of ESI in the LCS group was lower than in the LDH group. Level of evidence IV; Prospective hospital-based study.


2019 ◽  
Vol 46 (5) ◽  
pp. E9 ◽  
Author(s):  
Dong Hwa Heo ◽  
Dong Chan Lee ◽  
Choon Keun Park

OBJECTIVERecently, minimally invasive unilateral laminotomy with bilateral decompression (ULBD) has been performed for lumbar stenosis using endoscopic approaches. The object of this retrospective study was to compare the clinical and radiological outcomes of three types of minimally invasive decompressive surgery: microsurgery, percutaneous uniportal endoscopic surgery, and percutaneous biportal endoscopic surgery.METHODSIn the period from March 2016 to December 2017, minimally invasive ULBD was performed using microscopy, a uniportal endoscopic approach, or a biportal endoscopic approach to treat lumbar canal stenosis. Patients were classified into three groups based on the surgery they had undergone. The angle of medial facetectomy area and postoperative dural expansion were measured using MR images. The visual analog scale (VAS) score for leg and back pain, Oswestry Disability Index (ODI), operation time, and complications were assessed. Clinical and radiological parameters were compared among the three groups.RESULTSThere were 33 patients in the microscopy group, 37 in the biportal endoscopy group, and 27 in the uniportal endoscopy group. Preoperatively stenotic dural areas were significantly expanded in each of the three groups after surgery (p < 0.05). Mean dural expansion in the uniportal endoscopy group was significantly lower than that in the microscopy or biportal endoscopy group (p < 0.05). The mean angle of the facetectomy in the biportal endoscopic group was significantly lower than that in the microscopic group or uniportal endoscopic group (p < 0.05). On the 1st day after surgery, the VAS score for back pain was significantly higher in the microscopic group than in the uniportal or biportal endoscopic group (p < 0.05). However, there were no significant differences in the VAS score for back pain, VAS score for leg pain, or ODI at the final follow-up among the three groups (p > 0.05).CONCLUSIONSAlthough radiological results were different among the three groups of patients, postoperative clinical outcomes were significantly improved after each type of surgery. The percutaneous biportal or uniportal endoscopic approach offers the advantage of reduced immediate postoperative pain. A percutaneous uniportal or biportal endoscopic lumbar approach may be effective for the treatment of lumbar central stenosis and an alternative to conventional microsurgical decompression.


2006 ◽  
Vol 5 (6) ◽  
pp. 494-499 ◽  
Author(s):  
Manabu Sasaki ◽  
Makoto Abekura ◽  
Shayne Morris ◽  
Chihiro Akiyama ◽  
Kazuya Kaise ◽  
...  

Object Microscopic bilateral decompression through a unilateral laminotomy (MBDUL) is a minimally invasive technique used to treat lumbar canal stenosis (LCS). In the present study, MBDUL was performed to treat LCS in eight patients undergoing hemodialysis. Methods Surgical outcomes were evaluated using the Japanese Orthopaedic Association (JOA) scale (highest possible score 29). The JOA scale was administered preoperatively, at 1 month and 3 months postoperatively, and at the final follow-up examination. One patient refused to undergo the postoperative assessment after the 1-month examination; the mean follow-up duration of the remaining seven patients was 24 months (range 18–31 months). The mean age at the time of surgery was 62 years (range 48–76 years), and the mean duration of hemodialysis therapy was 21.4 years (range 3–28 years). All patients could walk within 2 days of surgery. The mean angle of the straight leg–raising (SLR) test was 53.8° preoperatively, and this increased to 69.4° postoperatively. Six patients felt enhancement of sciatica or leg pain when performing the SLR test preoperatively, a finding that was absent postoperatively at least until the final follow-up examination. The mean preoperative JOA score was 11.6 (range 4–22), and the score markedly improved to 19.8 (range 15–23) at 1 month and 20.6 (range 16–25) at 3 months. The mean JOA score decreased to 17.1 (range 12–25) at the final follow-up examination, but this decrease was attributed to other physical disorders. Conclusions The authors conclude that MBDUL is a safe and effective surgical treatment for patients undergoing hemodialysis who are suffering from LCS.


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