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PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation.

ABSTRACT: INTRODUCTION:Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the treatment of lumbar disc herniation. METHOD AND ANALYSIS:In total, 682 patients between 18 and 70 years of age with >10 weeks of radiating pain or with >6 weeks of excessive radiating pain are to be recruited from participating centres. Patients must have an indication for surgery based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Patients are to be randomised to PTED or open microdiscectomy. The primary outcome is self-reported leg pain measured by the 0-100?mm Visual Analogue Scale. Secondary outcomes include self-reported health and functional status, back pain, self-perceived recovery and a physical examination. Outcomes will be measured the day following surgery, at 2, 4 and 6 weeks, and at 3, 6, 9, 12 and 24 months. Physical examination will be performed at 6 weeks, and 3 and 12 months. An economic evaluation will be performed from a societal perspective and cost questionnaires will be used (eg, EQ-5D-5L). The data will be analysed longitudinally; the non-inferiority margin for the primary outcome is 5. Bootstrapping techniques will be used for the economic evaluation. ETHICS AND DISSEMINATION:This study has received approval of the Medical Ethical Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The results will be published in an international peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER:NCT02602093; Pre-results, recruiting stage.

SUBMITTER: Seiger A

PROVIDER: S-EPMC5778332 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation.

Seiger Ankie A Gadjradj Pravesh S PS Harhangi Biswadjiet S BS van Susante Job Lc JL Peul Wilco C WC van Tulder Maurits W MW de Boer Michiel R MR Rubinstein Sidney M SM

BMJ open 20171221 12

<h4>Introduction</h4>Lumbosacral radicular syndrome is often caused by a disc herniation. The standard surgical technique to remove a disc herniation is open microdiscectomy. An alternative technique is percutaneous transforaminal endoscopic discectomy (PTED), which is less invasive. In the Netherlands, PTED is not currently considered as standard care, and therefore not reimbursed within public health insurance. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been des ...[more]

PMID: 29273659

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Project description:Study designSecondary analysis of data from a concurrent randomized trial and cohort study.ObjectiveThe aim of this study was to determine risks and predictors of recurrent pain following standard open discectomy for subacute/chronic symptomatic lumbar disc herniation (SLDH).Summary of background dataMost previous studies of recurrence after discectomy do not explicitly define pain resolution and recurrence, and do not account for variable durations of time at risk for recurrence.MethodsWe used survival analysis methods to examine predictors of leg pain recurrence. For individuals with initial resolution of leg pain, we defined recurrent leg pain as having leg pain, receiving lumbar epidural steroid injections, or undergoing lumbar surgery subsequent to initial leg pain resolution. We calculated cumulative risks of leg pain recurrence using Kaplan-Meier survival curves, and examined predictors of recurrence using Cox proportional hazards models. We used similar methods to examine LBP recurrence.ResultsOne- and three-year cumulative risks of leg pain recurrence were 20% and 45%, respectively. One- and three- year leg pain recurrence risks were substantially lower in participants with complete initial resolution of leg pain (17% and 41%, respectively) than in those without (27% and 54%, respectively). In multivariate analyses, complete leg pain resolution (adjusted hazard ratio [aHR] 0.69; 95% confidence interval [CI] 0.52-0.90), smoking (aHR 1.68 [95% CI 1.22-2.33]), and depression (aHR 1.74 [95% CI 1.18-2.56]) predicted leg pain recurrence. The 1- and 3-year risk of LBP recurrence was 29% and 65%, respectively. LBP recurrence risk at 3 years was substantially lower in participants with complete initial resolution of LBP than in those without, but not at 1 year.ConclusionRecurrence of leg pain and LBP is common after discectomy for SLDH. Cumulative risks of both leg pain and LBP recurrence were generally lower in participants achieving complete initial resolution of pain post-discectomy.Level of evidence2.

Project description:Background:Percutaneous endoscopic transforaminal discectomy (PETD) is regarded as a viable alternative option for upper lumbar disc herniation (LDH). However, few studies have evaluated PETD for upper LDH, and no study has compared the advantages of endoscopic procedures versus conventional surgery. The present study was aimed at comparing the surgical outcome and safety of PETD versus conventional open lumbar discectomy in the treatment of upper LDH. Methods:Data from 42 patients treated for upper LDH from July 2015 to July 2018 were retrospectively analyzed, including 21 patients treated with PETD (PETD group) and 21 patients treated with conventional posterior lumbar discectomy (open group). The two groups were compared regarding demographic information, physical examination, radiological evaluations, and perioperative indicators. The clinical outcomes were assessed in accordance with the Oswestry Disability Index (ODI), visual analog scale (VAS), and modified MacNab criteria. Results:The postoperative ODI and VAS scores were significantly improved in both groups compared with the preoperative baseline values (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (P < 0.001), and the satisfactory rate was 90.5% in both groups in accordance with the modified MacNab criteria. There were no significant differences between the two groups in the clinical outcomes and complication rate (. Conclusions:PETD has a similar outcome to the conventional surgical method for the treatment of upper LDH but provides the typical advantages of minimally invasive procedures such as reduced iatrogenic injury, minimal activity restrictions, and accelerated ambulation recovery postoperatively.

Dataset Information

PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation.

Publications

PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation.

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