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

NCT02602093 | Unknown

• 1 other identifier: ZonMw 80-83700-98-15503
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disk Herniation

Keywords

Lumbar Disk Herniation; Percutaneous Transforaminal Endoscopic Discectomy; Micro Discectomy; Minimal Invasive Spine Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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.

  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)

  Baseline, Day after surgery, 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 and 24 months after surgery

Study Arms (2)

Transforaminal Endoscopic Discectomy

ACTIVE COMPARATOR

Surgery: Patients will undergo Percutaneous Transforaminal Endoscopic Discectomy.

Procedure: Transforaminal Endoscopic Discectomy

Open Microdiscectomy

ACTIVE COMPARATOR

Surgery: Patients will undergo conventional micro discectomy.

Procedure: Open Microdiscectomy

Interventions

Transforaminal Endoscopic Discectomy PROCEDURE

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.

Also known as: PTED

Transforaminal Endoscopic Discectomy

Open Microdiscectomy PROCEDURE

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.

Also known as: OM

Open Microdiscectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• VU University of Amsterdam: collaborator
• Erasmus Medical Center: collaborator
• The Elisabeth-TweeSteden Hospital: collaborator
• Rijnstate Hospital: collaborator
• Alrijne Hospital: collaborator
• Park MC: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3000 CA, Netherlands

RECRUITING

Related Publications (8)

• 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.

  PMID: 29273659 BACKGROUND

• 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.

  PMID: 26945128 BACKGROUND

• 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.

  PMID: 26828884 BACKGROUND

• 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.

  PMID: 35610755 BACKGROUND

• 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.

  PMID: 35589376 BACKGROUND

• 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.

  PMID: 35190388 BACKGROUND

• 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.

  PMID: 35185010 BACKGROUND

• 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.

  PMID: 33290374 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Biswadjiet Harhangi, MD, PhD

  Erasmus Medical Center

  STUDY DIRECTOR

• Sidney Rubinstein, PhD

  VU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pravesh Gadjradj, MD

CONTACT

p.gadjradj@erasmusmc.nl

Sidney Rubinstein, PhD

CONTACT

s.m.rubinstein@vu.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 11, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2024
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 24 months
• Access Criteria: Upon reasonable request

Locations

NL (1)