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

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ClinicalTrials.gov Identifier: NCT01997086
Recruitment Status : Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lumbar Herniated Disc Procedure: Percutaneous transforaminal endoscopic discectomy (PTED) Procedure: Microendoscopic discectomy (MED) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Percutaneous Transforaminal Endoscopic Discectomy (PTED) Versus Microendoscopic Discectomy (MED) for the Treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study
Study Start Date : October 2013
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Hernia

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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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. ]
  2. Histological analysis of surgical lumbar intervertebral disc tissue [ Time Frame: postoperation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997086


Locations
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China, Guangdong
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510630
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Limin Rong, M.D. Third Affiliated Hospital, Sun Yat-Sen University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Limin Rong, Prof., M.D., Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01997086    
Other Study ID Numbers: PTED-MED
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Intervertebral Disc Displacement
Hernia
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases