Lumbar Herniated Disc Clinical Trial
Official title:
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.
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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