- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02602093
Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)
(Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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, with including 50 patients in the PTED-group per surgeon who will learn the procedure "the learning curve". Therefore, for the 3 surgeons who will learn the technique, the first 50 patients who will undergo PTED (150 total) will be analyzed seperatly.
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pravesh Gadjradj, MD
- Email: p.gadjradj@erasmusmc.nl
Study Contact Backup
- Name: Sidney Rubinstein, PhD
- Email: s.m.rubinstein@vu.nl
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3000 CA
- Recruiting
- Erasmus MC
-
Contact:
- Pravesh S MC, MD
- Phone Number: 0107033236
- Email: p.gadjradj@erasmusmc.nl
-
Contact:
- Sidney
-
Principal Investigator:
- Sanjay Harhangi, MD, PhD
-
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:
- Arnold Vreeling, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transforaminal Endoscopic Discectomy
Surgery: Patients will undergo Percutaneous 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 Names:
|
Active Comparator: Open Microdiscectomy
Surgery: Patients will undergo conventional micro discectomy.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 24 and 60 months after surgery NRS was added for internal validation
|
The pain intensity in the leg will be measured on a scale from 0 to 100 mm
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, 24 and 60 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
|
Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months , 12, 24 and 60 months after surgery
|
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 and 24 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.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months and , 12 and 24 months after surgery
|
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, 24 and 60 months after surgery NRS was added for internal validation
|
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.
|
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
|
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, 24 and 60 months after surgery. NRS was added for internal validation
|
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.
|
Baseline, 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
|
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).
|
Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery
|
Perceived recovery
Time Frame: Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 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'.
|
Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
|
Patient satisfaction
Time Frame: 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 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'.
|
2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
|
Changes on the SF-36
Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 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.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
|
Complications
Time Frame: through study completion, up to 1, 2 year and 5 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
|
through study completion, up to 1, 2 year and 5 of follow-up
|
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.
|
Baseline, 6 weeks, 3 months and 12 months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Biswadjiet Harhangi, MD, PhD, Erasmus Medical Center
- Principal Investigator: Sidney Rubinstein, PhD, VU
Publications and helpful links
General Publications
- Gadjradj PS, Harhangi BS. Percutaneous Transforaminal Endoscopic Discectomy for Lumbar Disk Herniation. Clin Spine Surg. 2016 Nov;29(9):368-371. doi: 10.1097/BSD.0000000000000366.
- Seiger A, Gadjradj PS, Harhangi BS, van Susante JL, Peul WC, van Tulder MW, de Boer MR, Rubinstein SM. PTED study: design of a non-inferiority, randomised controlled trial to compare the effectiveness and cost-effectiveness of percutaneous transforaminal endoscopic discectomy (PTED) versus open microdiscectomy for patients with a symptomatic lumbar disc herniation. BMJ Open. 2017 Dec 21;7(12):e018230. doi: 10.1136/bmjopen-2017-018230.
- Gadjradj PS, van Tulder MW, Dirven CM, Peul WC, Harhangi BS. Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series. Neurosurg Focus. 2016 Feb;40(2):E3. doi: 10.3171/2015.10.FOCUS15484.
- Gadjradj PS, Depauw PR, Schutte PJ, Vreeling AW, Harhangi BS. Body Image and Cosmesis after Percutaneous Transforaminal Endoscopic Discectomy versus Conventional Open Microdiscectomy for Sciatica. Global Spine J. 2022 May 24:21925682221105271. doi: 10.1177/21925682221105271. Online ahead of print.
- Gadjradj PS. Full-endoscopic lumbar disc surgery: the new gold standard? (PhD Academy Award). Br J Sports Med. 2022 May 19:bjsports-2022-105434. doi: 10.1136/bjsports-2022-105434. Online ahead of print. No abstract available.
- Gadjradj PS, Rubinstein SM, Peul WC, Depauw PR, Vleggeert-Lankamp CL, Seiger A, van Susante JL, de Boer MR, van Tulder MW, Harhangi BS. Full endoscopic versus open discectomy for sciatica: randomised controlled non-inferiority trial. BMJ. 2022 Feb 21;376:e065846. doi: 10.1136/bmj-2021-065846.
- Gadjradj PS, Broulikova HM, van Dongen JM, Rubinstein SM, Depauw PR, Vleggeert C, Seiger A, Peul WC, van Susante JL, van Tulder MW, Harhangi BS. Cost-effectiveness of full endoscopic versus open discectomy for sciatica. Br J Sports Med. 2022 Feb 20;56(18):1018-25. doi: 10.1136/bjsports-2021-104808. Online ahead of print.
- Gadjradj PS, Harhangi BS, Amelink J, van Susante J, Kamper S, van Tulder M, Peul WC, Vleggeert-Lankamp C, Rubinstein SM. Percutaneous Transforaminal Endoscopic Discectomy Versus Open Microdiscectomy for Lumbar Disc Herniation: A Systematic Review and Meta-analysis. Spine (Phila Pa 1976). 2021 Apr 15;46(8):538-549. doi: 10.1097/BRS.0000000000003843.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZonMw 80-83700-98-15503
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
- Analytic Code
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lumbar Disk Herniation
-
CHU de ReimsRecruiting
-
Muş Alparlan UniversityCompletedIntervertebral Disc Displacement | Disk Herniated Lumbar | Disc HerniationTurkey
-
Riphah International UniversityCompletedDisk Herniated LumbarPakistan
-
NEOS SurgeryRecruitingDisk Herniated Lumbar | Disc HerniationSpain
-
Quanta MedicalCousin BiotechRecruitingDisk Herniated LumbarFrance
-
Medtronic France SASDePuy Synthes; LDR MédicalUnknownLumbar Total Disk ReplacementFrance
-
Spine Centre of Southern DenmarkCompletedSurgery | Disk Herniated Lumbar | PhysiotherapyDenmark
-
Chulalongkorn UniversityRecruitingDisk Herniated Lumbar | Radicular Pain | Intradiscal RadiofrequencyThailand
-
Giresun UniversityCompletedIntraocular Pressure | Anesthesia | Disk Herniated LumbarTurkey
Clinical Trials on Transforaminal Endoscopic Discectomy
-
Third Affiliated Hospital, Sun Yat-Sen UniversityActive, not recruiting
-
Shaanxi Provincial People's HospitalEnrolling by invitationLumbar Disc HerniationChina
-
Southeast University, ChinaUnknownLumbar Disc Herniation
-
First Affiliated Hospital Xi'an Jiaotong UniversityUnknownLumbar Disc Herniation | Chronic Low Back PainChina
-
Shenzhen People's HospitalRecruitingLumbar Disc HerniationChina
-
Peking University People's HospitalUnknownLumbar Disc Herniation
-
Second Affiliated Hospital of Wenzhou Medical UniversityCompletedLumbar Spinal Stenosis | Degeneration Disc
-
Justin Parker Neurological InstituteCompletedDegenerative Disc DiseaseUnited States
-
Gadjah Mada UniversityCompletedHerniated Nucleus PulposusIndonesia
-
Assiut UniversityCompletedLumbar Disc Herniation