US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation
- Conditions
- Lumbar Herniated Disc
- Interventions
- Procedure: US-MR image fusion-guided PTEDProcedure: fluoroscopy-guided PTED
- Registration Number
- NCT03403244
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description US-MR image fusion-guided PTED US-MR image fusion-guided PTED US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique. fluoroscopy-guided PTED fluoroscopy-guided PTED fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy.
- Primary Outcome Measures
Name Time Method radiation exposure during operation dose of radiation exposure
- Secondary Outcome Measures
Name Time Method puncture accuracy during operation the accuracy of puncture position confirmed by fluoroscopy.
puncture satisfaction of surgeon during operation 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
comfort of patient during operation 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
degree of pain preoperation, immediately postoperation, 1 week postoperation Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)
degree of disability preoperation, immediately postoperation, 1 week postoperation Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain）
puncture time during operation the time from the begin of puncture to the confirmation of optimal puncture
Trial Locations
- Locations (1)
the Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China