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Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study).

ABSTRACT: There are several posterior decompression techniques for lumbar spinal stenosis (LSS). There is a trend towards performing less invasive surgical procedures, but no multicentre randomized controlled trials have evaluated the relative efficacy of these techniques at short and long-term.A multicentre randomized controlled trial [the Spinal Stenosis Trial (SST) (part of the NORDSTEN study)] including 465 patients aged 18-80 years with neurogenic claudication or radiating pain and MRI findings indicating lumbar spinal stenosis without spondylolisthesis is performed to compare three posterior decompression techniques: unilateral laminotomy with crossover, bilateral laminotomy and spinous process osteotomy. The primary outcome is change in Oswestry Disability Index (ODI 2 years postoperatively). Secondary outcomes are change in EQ-5D, Zurich Claudication Questionnaire, and Numeric Rating Scale for leg-pain and back-pain. Also recorded were Global Perceived Effect score, complications, length of hospital stay, reoperation rate 2 years postoperatively, difference in recurrence of symptoms or postoperative instability, and MRI change in the dural sac area. Further, a 5 and 10 years follow-up is planned with the same outcome measures.Newer and less invasive techniques are increasingly favoured in surgery for LSS. This trial will compare the clinical and radiological results of three different techniques, and may contribute to better clinical decision making in the surgical treatment of LSS.ClinicalTrials.gov reference: NCT02007083 (November 22, 2013).

SUBMITTER: Hermansen E

PROVIDER: S-EPMC5361830 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study).

Hermansen Erland E Austevoll Ivar Magne IM Romild Ulla Kristina UK Rekeland Frode F Solberg Tore T Storheim Kjersti K Grundnes Oliver O Aaen Jørn J Brox Jens Ivar JI Hellum Christian C Indrekvam Kari K

BMC musculoskeletal disorders 20170321 1

<h4>Background</h4>There are several posterior decompression techniques for lumbar spinal stenosis (LSS). There is a trend towards performing less invasive surgical procedures, but no multicentre randomized controlled trials have evaluated the relative efficacy of these techniques at short and long-term.<h4>Method/design</h4>A multicentre randomized controlled trial [the Spinal Stenosis Trial (SST) (part of the NORDSTEN study)] including 465 patients aged 18-80 years with neurogenic claudication ...[more]

PMID: 28327114

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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: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.

Project description:PurposeThis prospective cohort study reports on a modified technique, namely precise safety decompression via double percutaneous lumbar foraminoplasty (DPLF) and percutaneous endoscopic lumbar decompression (PELD) for lateral lumbar spinal canal (LLSC) stenosis, and its short-term clinical outcomes.MethodsThe study analyzed 69 patients with single-level LLSC stenosis simultaneously occurring in both zones 1 and 2 (defined as retrodiscal space and upper bony lateral recess respectively by new LLSC classification) who underwent DPLF-PELD from November 2018 to April 2019. Clinical outcomes were evaluated according to preoperative, 3 months postoperatively, and last follow-up, via leg pain/low back pain (LBP) visual analog scale (VAS) scores, Oswestry disability index (ODI) scores, and the Macnab criteria. The postoperative MRI and CT were used to confirm the complete decompression, and flexion-extension x-rays at the last follow-up were used to observe lumbar stability.ResultsAll patients successfully underwent DPLF-PELD, and the stenosis was completely decompressed, confirmed by postoperative MRI and CT. The mean follow-up duration was 13 months (range: 8-17 months). The mean preoperative leg pain VAS score is 7.05 ± 1.04 (range 5-9), which decreased to 1.03 ± 0.79(range: 0-3) at 3 months postoperatively and to 0.75 ± 0.63 (range: 0-2) by the last follow-up visit (p < 0.05). The mean preoperative ODI was 69.8 ± 9.05 (range: 52-85), which decreased to 20.3 ± 5.52 (range: 10-35) at the third month postoperatively and to 19.6 ± 5.21 (range: 10-34) by the final follow-up visit (p < 0.05). The satisfactory (excellent or good) results were 94.2%. There was one patient with aggravated symptoms, which were relieved after an open surgery. Two patients had a dural tear, and two patients suffered postoperative LBP. No recurrence or segmental instability was observed at the final follow-up.ConclusionDPLF-PELD could be a good alternative for the treatment of LLSC stenosis patients whose stenosis occurred in both zones 1 and 2.Trial registrationChinese Clinical Trial Registry ( ChiCTR1800019551 ). Registered 18 November 2018.

Dataset Information

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study).

Publications

Study-protocol for a randomized controlled trial comparing clinical and radiological results after three different posterior decompression techniques for lumbar spinal stenosis: the Spinal Stenosis Trial (SST) (part of the NORDSTEN Study).

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