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

NAUnknownINTERVENTIONAL
Enrollment

682

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

May 31, 2020

Study Completion Date

May 31, 2024

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.

Trial Locations (1)

3000 CA

RECRUITING

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

VU University of Amsterdam

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

The Elisabeth-TweeSteden Hospital

OTHER

collaborator

Rijnstate Hospital

OTHER

collaborator

Alrijne Hospital

OTHER

collaborator

Park MC

UNKNOWN

lead

Amsterdam UMC, location VUmc

OTHER

NCT02602093 - Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study) | Biotech Hunter | Biotech Hunter