Clinical trial NCT02602093: Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Lumbar Disc Herniation (PTED-study)
Official title: (Cost) Effectiveness of Percutaneous Transforaminal Endoscopic Discectomy vs. Open Microdiscectomy for Patients With Symptomatic Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Disk Herniation
Keywords: Lumbar Disk Herniation
Percutaneous Transforaminal Endoscopic Discectomy
Micro Discectomy
Minimal Invasive Spine Surgery
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: VU University of Amsterdam
name: Erasmus Medical Center
name: The Elisabeth-TweeSteden Hospital
name: Rijnstate Hospital
name: Alrijne Hospital
name: Park MC
First posted: 2015-11-11
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Changes on the Oswestry Disability Index
timeFrame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months , 12, 24 and 60 months after surgery
measure: Costs of treatment measured using cost questionnaires filled out by the patients
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months and , 12 and 24 months after surgery
measure: Changes on the Visual Analogue Scale for Back 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
measure: Changes on the Quality of Life Visual Analogue Scale.
timeFrame: 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
measure: Changes on the EuroQoL (EQ-5D)
timeFrame: Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery
measure: Perceived recovery
timeFrame: Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
measure: Patient satisfaction
timeFrame: 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
measure: Changes on the SF-36
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12, 24 and 60 months after surgery
measure: Complications
timeFrame: through study completion, up to 1, 2 year and 5 of follow-up
measure: Physical Examination
timeFrame: Baseline, 6 weeks, 3 months and 12 months after surgery
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Biswadjiet Harhangi, MD, PhD
role: STUDY_DIRECTOR
affiliation: VU
name: Sidney Rubinstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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. 2024 Mar;14(2):390-399. doi: 10.1177/21925682221105271. Epub 2022 May 24.
citation: 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.
citation: 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.
citation: 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.
citation: 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.