Lumbar Disk HerniationNCT02602093
Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)
A study testing Transforaminal Endoscopic Discectomy and Open Microdiscectomy in people with Lumbar Disk Herniation, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disk Herniation
- What is being tested?
- Transforaminal Endoscopic Discectomy and Open Microdiscectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 682 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2016to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pravesh Gadjradj, MD contact
Sidney Rubinstein, PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3000 CA
Pravesh S MC, MD, 0107033236, p.gadjradj@erasmusmc.nl
Sidney
About this study
Official title: (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.
Read the 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.
- Conditions
- Lumbar Disk Herniation
- Being tested
- Transforaminal Endoscopic Discectomy, Open Microdiscectomy
- Keywords
- Lumbar Disk Herniation, Percutaneous Transforaminal Endoscopic Discectomy, Micro Discectomy, Minimal Invasive Spine Surgery
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transforaminal Endoscopic DiscectomyProcedure or surgery
Also called PTED
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.
Open MicrodiscectomyProcedure or surgery
Also called OM
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.
| Study group | Role | What they receive |
|---|---|---|
| Transforaminal Endoscopic Discectomy | Active comparator | Surgery: Patients will undergo Percutaneous Transforaminal Endoscopic Discectomy. Receives: Procedure: Transforaminal Endoscopic Discectomy |
| Open Microdiscectomy | Active comparator | Surgery: Patients will undergo conventional micro discectomy. Receives: Procedure: Open Microdiscectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on the Visual Analogue Scale for Leg Pain
The pain intensity in the leg will be measured on a scale from 0 to 100 mm
Measured: 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 outcomes (10)
Changes on the Oswestry Disability Index
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
Measured: 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
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.
Measured: 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
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.
Measured: 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.
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.
Measured: 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)
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).
Measured: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery
Perceived recovery
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'.
Measured: Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
Patient satisfaction
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'.
Measured: 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
Changes on the SF-36
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.
Measured: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
Complications
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
Measured: through study completion, up to 1, 2 year and 5 of follow-up
Physical Examination
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.
Measured: Baseline, 6 weeks, 3 months and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2020
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disk HerniationStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 682 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, VU University of Amsterdam, Erasmus Medical Center, The Elisabeth-TweeSteden Hospital, Rijnstate Hospital, Alrijne Hospital, Park MC
- Responsible party
- Principal investigator, P.S. Gadjradj, Erasmus Medical Center
- Investigators
- Biswadjiet Harhangi, MD, PhD, Study director, Erasmus Medical CenterSidney Rubinstein, PhD, Principal investigator, VU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602093
- Sponsor's protocol ID
- ZonMw 80-83700-98-15503
- Status last verified
- Jul 2022
- First submitted
- 5 Nov 2015
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 29273659Gadjradj 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.
PubMed 26945128Gadjradj 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.
PubMed 26828884Gadjradj 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. 2024 Mar;14(2):390-399. doi: 10.1177/21925682221105271. Epub 2022 May 24.
PubMed 35610755Gadjradj 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.
PubMed 35589376Gadjradj 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.
PubMed 35190388Gadjradj 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.
PubMed 35185010Gadjradj 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.
PubMed 33290374
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT02602093
- Acronym / sponsor ID
- ZonMw 80-83700-98-15503
- Conditions
- Lumbar Disk Herniation
- Keywords
- Lumbar Disk Herniation, Percutaneous Transforaminal Endoscopic Discectomy, Micro Discectomy, Minimal Invasive Spine Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 682 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, VU University of Amsterdam, Erasmus Medical Center, The Elisabeth-TweeSteden Hospital, Rijnstate Hospital, Alrijne Hospital, Park MC
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transforaminal Endoscopic Discectomy | Active comparator | Procedure: Transforaminal Endoscopic DiscectomySurgery: Patients will undergo Percutaneous Transforaminal Endoscopic Discectomy. |
| Open Microdiscectomy | Active comparator | Procedure: Open MicrodiscectomySurgery: Patients will undergo conventional micro discectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transforaminal Endoscopic DiscectomyAlso: PTEDLocal 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 or surgery | Transforaminal Endoscopic Discectomy |
| Open MicrodiscectomyAlso: OMGeneral 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. | Procedure or surgery | Open Microdiscectomy |
Primary outcome
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
10 secondary outcomes
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
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
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
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
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
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
Patient satisfaction
Time frame: 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
Complications
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Background: PubMed 29273659Seiger 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.
- Background: PubMed 26945128Gadjradj 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.
- Background: PubMed 26828884Gadjradj 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.
- Background: PubMed 35610755Gadjradj 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. 2024 Mar;14(2):390-399. doi: 10.1177/21925682221105271. Epub 2022 May 24.
- Background: PubMed 35589376Gadjradj 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.
- Background: PubMed 35190388Gadjradj 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.
- Background: PubMed 35185010Gadjradj 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.
- Background: PubMed 33290374Gadjradj 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pravesh Gadjradj, MD contact
Sidney Rubinstein, PhD contact
Biswadjiet Harhangi, MD, PhD study director
Erasmus Medical Center
Sidney Rubinstein, PhD principal investigator
VU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal Endoscopic Discectomy and Open Microdiscectomy in people with Lumbar Disk Herniation, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pravesh Gadjradj, MD (p.gadjradj@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02602093, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.