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
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Herniated Disc||Procedure: Percutaneous transforaminal endoscopic discectomy (PTED) Procedure: Microendoscopic discectomy (MED)||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- 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 ]
- 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. ]
- Histological analysis of surgical lumbar intervertebral disc tissue [ Time Frame: postoperation ]
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
|the Third Affiliated Hospital of Sun Yat-Sen University|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator:||Limin Rong, M.D.||Third Affiliated Hospital, Sun Yat-Sen University|