Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Hernia… (NCT02602093) | Clinical Trial Compass
UnknownNot Applicable
Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)
Netherlands682 participantsStarted 2016-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes on the Visual Analogue Scale for Leg Pain
Timeframe: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery NRS was added for internal validation