US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation
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| ClinicalTrials.gov Identifier: NCT03403244 |
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Recruitment Status : Unknown
Verified April 2018 by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was: Recruiting
First Posted : January 18, 2018
Last Update Posted : April 4, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lumbar Herniated Disc | Procedure: US-MR image fusion-guided PTED Procedure: fluoroscopy-guided PTED | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | January 1, 2018 |
| Estimated Primary Completion Date : | January 1, 2019 |
| Estimated Study Completion Date : | January 1, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Procedure: US-MR image fusion-guided PTED
patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED |
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Active Comparator: fluoroscopy-guided PTED
fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy.
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Procedure: fluoroscopy-guided PTED
patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED |
- radiation exposure [ Time Frame: during operation ]dose of radiation exposure
- puncture accuracy [ Time Frame: during operation ]the accuracy of puncture position confirmed by fluoroscopy.
- puncture satisfaction of surgeon [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: during operation ]the time from the begin of puncture to the confirmation of optimal puncture
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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): NCT03403244
| Contact: Limin Rong, MD | +862085252900 | ronglimin@21cn.com | |
| Contact: Zihao Chen, MD | +8615013228407 | chenzihao89@163.com |
| China, Guangdong | |
| the Third Affiliated Hospital of Sun Yat-Sen University | Recruiting |
| Guangzhou, Guangdong, China, 510630 | |
| Contact: Limin Rong, M.D. 862085252900 ronglimin@21cn.com | |
| Responsible Party: | Limin Rong, proffesor, Third Affiliated Hospital, Sun Yat-Sen University |
| ClinicalTrials.gov Identifier: | NCT03403244 |
| Other Study ID Numbers: |
US-MR guided PTED for LDH |
| First Posted: | January 18, 2018 Key Record Dates |
| Last Update Posted: | April 4, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Intervertebral Disc Displacement Hernia Pathological Conditions, Anatomical |
Spinal Diseases Bone Diseases Musculoskeletal Diseases |