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

Ankie Seiger, Pravesh S Gadjradj, Biswadjiet S Harhangi, Job Lc van Susante, Wilco C Peul, Maurits W van Tulder, Michiel R de Boer, Sidney M Rubinstein

Research output: Contribution to JournalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)e018230
JournalBMJ Open
Volume7
Issue number12
DOIs
Publication statusPublished - 21 Dec 2017

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Diskectomy
Cost-Benefit Analysis
Pain
Physical Examination
Radiculopathy
Back Pain
Health Insurance
Visual Analog Scale
Ambulatory Surgical Procedures
Netherlands
Health Status
Leg
Public Health
Costs and Cost Analysis
Non-Randomized Controlled Trials
Therapeutics

Keywords

  • Journal Article

Cite this

@article{bce34a45b5db4caab201c37058d01707,
title = "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.",
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doi = "10.1136/bmjopen-2017-018230",
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TY - JOUR

T1 - PTED study

T2 - 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

AU - Seiger, Ankie

AU - Gadjradj, Pravesh S

AU - Harhangi, Biswadjiet S

AU - van Susante, Job Lc

AU - Peul, Wilco C

AU - van Tulder, Maurits W

AU - de Boer, Michiel R

AU - Rubinstein, Sidney M

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2017/12/21

Y1 - 2017/12/21

N2 - 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.

AB - 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.

KW - Journal Article

U2 - 10.1136/bmjopen-2017-018230

DO - 10.1136/bmjopen-2017-018230

M3 - Article

VL - 7

SP - e018230

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

ER -