US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the 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 feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of 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) 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.

Official Title
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US-MR Image Fusion-guided Versus Fluoroscopy-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation: a Comparative Cohort Study

Conditions
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Lumbar Herniated Disc

Intervention / Treatment
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* Procedure: US-MR image fusion-guided PTED
* Procedure: fluoroscopy-guided PTED


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: persistent radicular pain. an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient single responsible segment of lumbar disc herniation L4-5 segment Exclusion Criteria: 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 Previous spinal surgery unable to collaborate during surgery far-lateral disc herniation
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US-MR image fusion-guided PTED<br>US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique. | Procedure: US-MR image fusion-guided PTED<br>* patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED<br>|
| Active Comparator: fluoroscopy-guided PTED<br>fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy. | Procedure: fluoroscopy-guided PTED<br>* patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiation exposure | dose of radiation exposure | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| puncture accuracy | the accuracy of puncture position confirmed by fluoroscopy. | during operation | 
| puncture satisfaction of surgeon | use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more satisfactory) to evaluate the satisfaction of surgeon during puncture | during operation | 
| comfort of patient | use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more comfortable) to evaluate the comfort of patient during puncture | during operation | 
| degree of pain | Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain) | preoperation, immediately postoperation, 1 week postoperation | 
| degree of disability | Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain） | preoperation, immediately postoperation, 1 week postoperation | 
| puncture time | the time from the begin of puncture to the confirmation of optimal puncture | during operation |