Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation

April 19, 2017 updated by: Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

Percutaneous Transforaminal Endoscopic Discectomy (PTED) Versus Microendoscopic Discectomy (MED) for the Treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study

The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic lumbar disc herniation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) and microendoscopic discectomy (MED) are two widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. As difference in operative approaches and iatrogenic injury, the clinical outcome might be dramatically different from each other.

In this study, a single center randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic LDH. We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.

Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PTED, and 2) patients diagnosed with lumbar disc herniation undergoing MED.

The primary outcomes of the study will be score of Oswestry Disability Index (ODI) as measured at pre- and post-operation, 1 month, 3 months, 6 months, and annually thereafter. Secondary outcomes include Visual Analog Scale (VAS), the SF-36 Health Survey, as well as post-operative radiological assessment. Treatment effect is defined as the difference in the mean change from baseline between the two groups. Lumbar intervertebral disc tissue would be obtained during surgery for histological analysis, in order to evaluate disc degeneration and find out risk factors of it.

On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of PTED versus MED for minimal invasive surgical treatment for symptomatic lumbar disc herniation.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Persistent radicular pain.
  • Signs including evidence of nerve root compression with a positive nerve root tension sign (straight leg raising test or femoral tension sign) or a corresponding sign of neurological deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution).
  • An imaging study (MRI or CT) showing LDH at a level and side corresponding to the patients radicular signs or symptoms.

Exclusion Criteria:

  • <18 or >65 years of age
  • Insufficient conservative treatment (6 weeks)
  • Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
  • Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
  • Equal to or more than two responsible level
  • High-grade migrated disc herniation
  • Previous spinal surgery
  • Possible pregnancy or other comorbid conditions contraindicating surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Transforaminal discectomy
patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED).
Procedure: Percutaneous transforaminal endoscopic discectomy (PTED)
Percutaneous transforaminal endoscopic discectomy
ACTIVE_COMPARATOR: Microendoscopic discectomy
Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED).
Procedure: Microendoscopic discectomy (MED)
Microendoscopic discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in pain and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI)
Time Frame: Baseline, post-operation, 1 month, 3 months, 6 months, and annually thereafter
Baseline, post-operation, 1 month, 3 months, 6 months, and annually thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in health-related quality of life as measured by the EQ-5D,Visual Analog Scale (VAS) and the SF-36 health status questionnaire, and the radiological changes in spine as measured by x-ray, CT or MRI.
Time Frame: Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter.
Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter.
Histological analysis of surgical lumbar intervertebral disc tissue
Time Frame: postoperation
postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Principal Investigator: Limin Rong, M.D., Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2023

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (ESTIMATE)

November 27, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTED-MED

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.

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