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

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ClinicalTrials.gov Identifier: NCT02602093
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : June 8, 2017
Sponsor:
Collaborators:
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
VU University of Amsterdam
Erasmus Medical Center
Elisabeth-TweeSteden Ziekenhuis
Sint Franciscus Gasthuis
Albert Schweitzer Hospital
Rijnstate Hospital
Alrijne Hospital
Park MC
Information provided by (Responsible Party):
P.S. Gadjradj, VU University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Lumbar Disk Herniation Procedure: Transforaminal Endoscopic Discectomy Procedure: Open Microdiscectomy Not Applicable

Detailed 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. 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.

Main study parameters/endpoints: There is one primary outcome: self-report leg pain (0- 10 numeric rating scale (NRS)); secondary outcomes include among others functional status (Oswestry Disability Index (ODI)) and are to be measured the day following treatment and at 2, 4, and 6 weeks, and 3, 6, 9,12 and 24 months. The data will be analyzed longitudinally, meaning there is no primary endpoint.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 682 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: (Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Hernia

Arm Intervention/treatment
Active Comparator: Transforaminal Endoscopic Discectomy
Surgery: Patients will undergo Percutaneous Transforaminal Endoscopic Discectomy.
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.
Other Name: PTED

Active Comparator: Open Microdiscectomy
Surgery: Patients will undergo conventional micro discectomy.
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.
Other Name: OM




Primary Outcome Measures :
  1. Changes on the Visual Analogue Scale for Leg Pain [ Time Frame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    The pain intensity in the leg will be measured on a scale from 0 to 100 mm.(worst imaginable pain). Since the trial was published in the trial registry, the protocol has been modified. NRS for leg pain (back pain and quality of life) was added. NRS and VAS scores showed comparable rates when measuring pain following surgery.


Secondary Outcome Measures :
  1. Changes on the Oswestry Disability Index [ Time Frame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months , 12 and 24 months after surgery ]
    There are 10 questions (items), each with 6 possible answers, each answer option receives a score of 0 to 5 points, yielding score range between 0 and 50, which is scaled to a 100% range. The questions are designed in a way to realize how the back or leg pain is affecting the patient's ability to manage in everyday life

  2. Costs of treatment measured using cost questionnaires filled out by the patients [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months after surgery ]
    Cost questionnaires will be completed at the prescribed measurements. Hospitalisation for surgery will be registered using the case record forms. Other health care utilization (including physiotherapy, visits to GP and specialists, nursing care and medication), patient costs, and absenteeism from work will be measured using cost questionnaires filled out by the patients.

  3. Changes on the Visual Analogue Scale for Back Pain [ Time Frame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    The pain intensity in the back will be measured on a scale from 0 (no pain) to 100 mm (worst imaginable pain). An NRS was added as well.

  4. Changes on the Quality of Life Visual Analogue Scale. [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    To represent the patients' perspective, utility will also be estimated using a VAS for the valuation of the patient's health state (ranging from 0 = as bad as death to 100 mm = perfect health). An NRS was added as well.

  5. Changes on the EuroQoL (EQ-5D) [ Time Frame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months,, 12 and 24 months after surgery ]
    The EuroQoL (EQ-5D) will be used for the cost utility analysis. The tool measures five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each dimension consists of one item, while five levels are distinguished (no, slight, moderate, severe problems, unable to do).

  6. Perceived recovery [ Time Frame: Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    To measure the perceived recovery a seven-point Likert scale will be used. The score on this scale vary from 'completely recovered' to 'worse than ever'.

  7. Patient satisfaction [ Time Frame: 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    To measure patient satisfaction a seven-point Likert scale will be used. The score on this scale vary from 'completely satisfied with current symptoms' to 'completely dissatisfied with current symptoms'.

  8. Changes on the SF-36 [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery ]
    The SF-36 will be used as a generic quality-of-life questionnaire. The SF-36 questionnaire has been validated and found reliable for low back pain.

  9. Complications [ Time Frame: through study completion, up to 1 and 2 year of follow-up ]
    A systematic assessment of complications (including wound infection, deep venous thrombosis, urine tract infection, hematoma, and progressive neurological deficit) will be recorded out by the surgeon and research nurse, and these data are to be extracted from the patient chart. Moreover, surgeons will be asked for perioperative complications

  10. Physical Examination [ Time Frame: Baseline, 6 weeks, 3 months and 12 months after surgery ]
    The wound will be inspected and a standard neurological examination will be performed. This standard neurologic examination includes the Body Image and Cosmesis Scale, the (crossed) leg raising test, patellar and tendon reflexes, sensibility in the lumbosacral dermatome region, leg muscle test, abdominal muscle strength and finger-floor distance.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602093


Contacts
Contact: Pravesh Gadjradj, BSc p.gadjradj@erasmusmc.nl
Contact: Sidney Rubinstein, PhD s.m.rubinstein@vu.nl

Locations
Netherlands
VU University Recruiting
Amsterdam, Netherlands
Contact: Pravesh Gadjradj, BSc       p.gadjradj@erasmusmc.nl   
Contact: Sidney Rubinstein, PhD       s.m.rubinstein@vu.nl   
Principal Investigator: Sanjay Harhangi, MD, PhD         
Principal Investigator: Wilco Peul, MD, PhD, MBA         
Principal Investigator: Maurits van Tulder, PhD         
Sub-Investigator: Job van Susante, MD, PhD         
Sub-Investigator: Paul Depauw, MD, PhD         
Sub-Investigator: Pieter Schutte, MD         
Sub-Investigator: Alof Dallenga, MD         
Sub-Investigator: Ernst Delwel, MD         
Principal Investigator: Ankie Seiger, MSc         
Sponsors and Collaborators
VU University Medical Center
Leiden University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
VU University of Amsterdam
Erasmus Medical Center
Elisabeth-TweeSteden Ziekenhuis
Sint Franciscus Gasthuis
Albert Schweitzer Hospital
Rijnstate Hospital
Alrijne Hospital
Park MC
Investigators
Principal Investigator: Maurits van Tulder, PhD VU University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: P.S. Gadjradj, BSc, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02602093     History of Changes
Other Study ID Numbers: ZonMw 80-83700-98-15503
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by P.S. Gadjradj, VU University Medical Center:
Lumbar Disk Herniation
Percutaneous Transforaminal Endoscopic Discectomy
Micro Discectomy
Minimal Invasive Spine Surgery

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical