Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)

Last updated: July 6, 2022
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

N/A

Clinical Study ID

NCT02602093
ZonMw 80-83700-98-15503
  • Ages 18-70
  • All Genders

Study Summary

Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000 to 75,000 people. Open microdiscectomy is the standard surgical technique.

In recent years, several surgical techniques have been developed including, percutaneous transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The Netherlands, evidence of its effects is lacking, leading to a heated debate. The current position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support its use; therefore, PTED is not financially covered. The consequence is, patients are forced to pay the costs of treatment themselves. This study is expected to provide the necessary data to answer the question regarding effects and costs of PTED vs. open microdiscectomy, and help resolve the current debate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 10 weeks of radiating pain with- or without motor or sensory loss in the leg, or with > 6weeks of excessive radiating pain and no tendency for any clinical improvement andstrong patient preference for surgery;
  • Indication for an operation according to consensus;
  • MRI demonstrating lumbar disc herniation with nerve compression with or withoutconcomitant spinal or lateral recess stenosis or sequestration;
  • Sufficient knowledge of the Dutch language in order to complete forms and followinstructions independently.

Exclusion

Exclusion Criteria:

  • Previous surgery on the same or adjacent disc level;
  • Cauda equina syndrome (CES);
  • Spondylytic or degenerative spondylolisthesis;
  • Pregnancy;
  • Severe comorbid medical or psychiatric disorder (ASA>2);
  • Severe caudal or cranial sequestration;
  • Moving abroad at short notice

Study Design

Total Participants: 682
Study Start date:
January 01, 2016
Estimated Completion Date:
May 31, 2024

Study Description

Rationale: Lumbosacral radicular syndrome (LSRS) is caused by a herniated lumbar nucleus pulposus (HNP) and the estimated annual incidence in The Netherlands ranges between 60,000 to 75,000 people. Open microdiscectomy is the standard surgical technique.

In recent years, several surgical techniques have been developed including, percutaneous transforaminal endoscopic discectomy (PTED). While PTED is gaining popularity in The Netherlands, evidence of its effects is lacking, leading to a heated debate. The current position of Zorginstituut Nederland (ZiN) is that there is insufficient evidence to support its use; therefore, PTED is not financially covered. The consequence is, patients are forced to pay the costs of treatment themselves. This study is expected to provide the necessary data to answer the question regarding effects and costs of PTED vs. open microdiscectomy, and help resolve the current debate. Objective: To determine the effects and costs of PTED vs. open microdiscectomy. Study design: Pragmatic, multi-center non-inferiority randomized controlled trial (RCT) with subsequent observational study once sufficient subjects have been recruited for the RCT.

Study population: In total, 682 subjects are to be included, with including 50 patients in the PTED-group per surgeon who will learn the procedure "the learning curve". Therefore, for the 3 surgeons who will learn the technique, the first 50 patients who will undergo PTED (150 total) will be analyzed seperatly.

The inclusion criteria are as follows: subjects 18-70 years of age with > 10 weeks of radiating pain with- or without motor or sensory loss in the leg, or with > 6 weeks of excessive radiating pain and no tendency for any clinical improvement and strong patient preference for surgery. There must also be an indication for an operation and a MRI demonstrating lumbar disc herniation with nerve compression with or without concomitant spinal or lateral recess stenosis or sequestration.

Participants must also have sufficient knowledge of the Dutch language.

Connect with a study center

  • Erasmus MC

    Rotterdam, Zuid-Holland 3000 CA
    Netherlands

    Active - Recruiting

  • VU University

    Amsterdam,
    Netherlands

    Site Not Available

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