(Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation

Status: Unknown
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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 and strong patient preference for surgery;

• Indication for an operation according to consensus;

• MRI demonstrating lumbar disc herniation with nerve compression with or without concomitant spinal or lateral recess stenosis or sequestration;

• Sufficient knowledge of the Dutch language in order to complete forms and follow instructions independently.

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Pravesh Gadjradj, MD
p.gadjradj@erasmusmc.nl
Backup
Sidney Rubinstein, PhD
s.m.rubinstein@vu.nl
Time Frame
Start Date: 2016-01
Completion Date: 2024-05
Participants
Target number of participants: 682
Treatments
Active_comparator: Transforaminal Endoscopic Discectomy
Surgery: Patients will undergo Percutaneous Transforaminal Endoscopic Discectomy.
Active_comparator: Open Microdiscectomy
Surgery: Patients will undergo conventional micro discectomy.
Authors
Sponsors
Collaborators: VU University of Amsterdam, Park MC, Alrijne Hospital, Erasmus Medical Center, Rijnstate Hospital, ZonMw: The Netherlands Organisation for Health Research and Development, The Elisabeth-TweeSteden Hospital
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov