Lumbar Herniated Disc Clinical Trial
Official title:
US-MR Image Fusion-guided Versus Fluoroscopy-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation: a Comparative Cohort Study
The purpose of this study is to evaluate the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of 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) a widely used minimal invasive surgical procedures, the effectiveness of
which has been proved to be comparable to conventional open discectomy. However, the use of
fluoroscopy may be usually required to indirectly visualize pertinent anatomy to achieve an
optimal result on radiographs. As we known, increased radiation exposure may be associated
with potential stochastic and deterministic adverse events. Therefore, it is important to
reduce the radiation dose of practitioners to minimize risk of potential radiation-induced
complications.
Ultrasound-MR fusion technique combines the advantages of ultrasound and MR, and overcome the
shortcomings of each single imaging method. It provides MR cross-sectional multiplanar images
that correspond to the acquired real-time US images, and all images can be displayed
simultaneously and in real time according to the angle of the US transducer. US-MR fusion
image has been widely used in prostate and liver intervention. However, to our limited
knowledge, there is only one research about the application of US-MR fusion image in lumbar
spinal surgery.
In this study, a comparative cohort study will be performed to evaluate feasibility and
efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for
the treatment of lumbar disc herniation(LDH). We will conduct the study at the 3rd affiliated
hospitals of Sun Yat-Sen University.
Two groups of patients will be investigated: patients diagnosed with lumbar disc herniation
undergoing US-MR image fusion-guided PTED (US-MR PTED), and fluoroscopy-guided PTED (FL
PTED).
The primary outcomes of the study will be radiation exposure and puncture time. Secondary
outcomes include fusion efficacy, puncture accuracy, puncture satisfaction of surgeon,
comfort of patient and clinical effectiveness.
On the basis of the results of this trial we will, for the first time, have scientific
evidence as to the feasibility and efficacy of US-MR image fusion-guided percutaneous
transforaminal endoscopic discectomy for the treatment of lumbar disc herniation.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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Phase 4 | |
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Phase 2 |