PTED examine: design of a non-inferiority, randomised managed trial to match the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for sufferers with a symptomatic lumbar disc herniation.
BMJ Open. 2017 Dec 21;7(12):e018230
Authors: Seiger A, Gadjradj PS, Harhangi BS, van Susante JL, Peul WC, van Tulder MW, de Boer MR, Rubinstein SM
INTRODUCTION: Lumbosacral radicular syndrome is commonly attributable to a disc herniation. The usual surgical method to take away a disc herniation is open microdiscectomy. An alternate method is percutaneous transforaminal endoscopic discectomy (PTED), which is much less invasive. Within the Netherlands, PTED shouldn’t be at the moment thought-about as normal care, and due to this fact not reimbursed inside public medical health insurance. A realistic, multicentre, non-inferiority, randomised managed trial has been designed to find out the effectiveness and cost-effectiveness of PTED versus open microdiscectomy for the therapy of lumbar disc herniation.
METHOD AND ANALYSIS: In whole, 682 sufferers between 18 and 70 years of age with >10 weeks of radiating ache or with >6 weeks of extreme radiating ache are to be recruited from collaborating centres. Sufferers will need to have a sign for surgical procedure primarily based on an MRI demonstrating compression of the nerve root from a lumbar disc herniation. Sufferers are to be randomised to PTED or open microdiscectomy. The first final result is self-reported leg ache measured by the Zero-100?mm Visible Analogue Scale. Secondary outcomes embody self-reported well being and useful standing, again ache, self-perceived restoration and a bodily examination. Outcomes shall be measured the day following surgical procedure, at 2, four and 6 weeks, and at three, 6, 9, 12 and 24 months. Bodily examination shall be carried out at 6 weeks, and three and 12 months. An financial analysis shall be carried out from a societal perspective and value questionnaires shall be used (eg, EQ-5D-5L). The information shall be analysed longitudinally; the non-inferiority margin for the first final result is 5. Bootstrapping methods shall be used for the financial analysis.
ETHICS AND DISSEMINATION: This examine has acquired approval of the Medical Moral Committee of the VU Medical Centre Amsterdam: NL50951.029.14. The outcomes shall be printed in a global peer-reviewed scientific journal.
TRIAL REGISTRATION NUMBER: NCT02602093; Pre-results, recruiting stage.
PMID: 29273659 [PubMed – in process]