Article Text

Download PDFPDF

Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial
  1. Ze Yan Liang,
  2. Yuan Dong Zhuang,
  3. Chun Mei Chen,
  4. Rui Wang
  1. Neurosurgery, Fujian Medical University Union Hospital, Fuzhou, Fujian, China
  1. Correspondence to Dr Chun Mei Chen; cmchen2009{at}sina.com

Abstract

Introduction For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH.

Methods and analysis A total of 280 patients (18–70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1 week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1 week, 1 month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5.

Ethics and dissemination Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.

Trial registration number ChiCTR1800015727; Pre-results.

  • clinical trials
  • neurosurgery

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Footnotes

  • ZYL and YDZ contributed equally.

  • Contributors CC, YZ, ZL and RW are the principal investigators and have coordinated all the phases of trial design, statistical analysis plan and drafting of the protocol. ZL and YZ wrote the manuscript. All authors contributed to refinement of the study protocol and approval of the final manuscript.

  • Funding The study was supported by Technology and Innovation Foundation of Fujian, China (grant no 2018Y9060 to CM), Medical Innovation Foundation of Fujian, China (grant no 2017-CX-21 to CM) and Science, Technology and Innovation Foundation of Fujian, China (grant no 2017Y9021 to YD).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02).

  • Provenance and peer review Not commissioned; externally peer reviewed.