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

Conditions

• Lumbar Disk Herniation

Interventions

PROCEDURE

Transforaminal Endoscopic Discectomy

Local anaesthesia is to be administered. Verification of the site to be performed by an image intensifier and depending upon the patient's posture, a line is to be drawn from the center of the herniation. The needle is to be set and position checked. After the needle has reached the correct position, a guidewire is inserted. Following that, a series of conical rods are introduced, subsequently a drill is introduced through the cannula. After drilling, the instruments are removed, but the guidewire is to remain in place. The endoscope with the working channels are introduced via an 8mm cannula. Following removal of the hernia, the cannula and endoscope are removed. The patient is to be treated on an outpatient basis.

PROCEDURE

Open Microdiscectomy

General or spinal anaesthesia is to be administered. Verification is to be performed using a Carm and the patient is to be positioned prone or in the salaam position. A paramedian incision is to be performed and the level is to be indicated. Loupe or microscope magnification is to be used. Laminotomy as well as foraminotomy is to be performed, if necessary. The amount of degenerative disc material to be removed is at the discretion of the attending surgeon. Post-operative policy will be followed and it is expected that the duration of recovery in the hospital may vary from 2-7 days, but the patient will be discharged as soon as medically responsible.

Sponsors & Collaborators

• ZonMw: The Netherlands Organisation for Health Research and Development

  collaborator OTHER

• VU University of Amsterdam

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• The Elisabeth-TweeSteden Hospital

  collaborator OTHER

• Rijnstate Hospital

  collaborator OTHER

• Alrijne Hospital

  collaborator OTHER

• Park MC

  collaborator UNKNOWN

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Biswadjiet Harhangi, MD, PhD · Erasmus Medical Center

• Sidney Rubinstein, PhD · VU

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2020-05-31

Completion

2024-05-31

Countries

• Netherlands

Study Locations