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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Lumbar Herniated Disc

Intervention / Treatment
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* Procedure: Percutaneous transforaminal endoscopic discectomy (PTED)
* Procedure: Microendoscopic discectomy (MED)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transforaminal discectomy<br>patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED). | Procedure: Percutaneous transforaminal endoscopic discectomy (PTED)<br>* Percutaneous transforaminal endoscopic discectomy<br>|
| Active Comparator: Microendoscopic discectomy<br>Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED). | Procedure: Microendoscopic discectomy (MED)<br>* Microendoscopic discectomy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter. | 
| Histological analysis of surgical lumbar intervertebral disc tissue |  | postoperation |