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US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation

Primary Purpose

Lumbar Herniated Disc

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
US-MR image fusion-guided PTED
fluoroscopy-guided PTED
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Herniated Disc

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. persistent radicular pain.
  2. an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient
  3. single responsible segment of lumbar disc herniation
  4. L4-5 segment

Exclusion Criteria:

  1. Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
  2. Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
  3. Equal to or more than two responsible level
  4. Previous spinal surgery
  5. unable to collaborate during surgery
  6. far-lateral disc herniation

Sites / Locations

  • the Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

US-MR image fusion-guided PTED

fluoroscopy-guided PTED

Arm Description

US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique.

fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy.

Outcomes

Primary Outcome Measures

radiation exposure
dose of radiation exposure

Secondary Outcome Measures

puncture accuracy
the accuracy of puncture position confirmed by fluoroscopy.
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
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
degree of pain
Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)
degree of disability
Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain)
puncture time
the time from the begin of puncture to the confirmation of optimal puncture

Full Information

First Posted
January 4, 2018
Last Updated
April 2, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03403244
Brief Title
US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Herniated Disc

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
US-MR image fusion-guided PTED
Arm Type
Experimental
Arm Description
US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique.
Arm Title
fluoroscopy-guided PTED
Arm Type
Active Comparator
Arm Description
fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy.
Intervention Type
Procedure
Intervention Name(s)
US-MR image fusion-guided PTED
Intervention Description
patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED
Intervention Type
Procedure
Intervention Name(s)
fluoroscopy-guided PTED
Intervention Description
patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED
Primary Outcome Measure Information:
Title
radiation exposure
Description
dose of radiation exposure
Time Frame
during operation
Secondary Outcome Measure Information:
Title
puncture accuracy
Description
the accuracy of puncture position confirmed by fluoroscopy.
Time Frame
during operation
Title
puncture satisfaction of surgeon
Description
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
Time Frame
during operation
Title
comfort of patient
Description
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
Time Frame
during operation
Title
degree of pain
Description
Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)
Time Frame
preoperation, immediately postoperation, 1 week postoperation
Title
degree of disability
Description
Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain)
Time Frame
preoperation, immediately postoperation, 1 week postoperation
Title
puncture time
Description
the time from the begin of puncture to the confirmation of optimal puncture
Time Frame
during operation

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Limin Rong, MD
Phone
+862085252900
Email
ronglimin@21cn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zihao Chen, MD
Phone
+8615013228407
Email
chenzihao89@163.com
Facility Information:
Facility Name
the Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Rong, M.D.
Phone
862085252900
Email
ronglimin@21cn.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32217792
Citation
Xie P, Feng F, Cao J, Chen Z, He B, Kang Z, He L, Wu W, Tan L, Li K, Zheng R, Rong L. Real-time ultrasonography-magnetic resonance image fusion navigation for percutaneous transforaminal endoscopic discectomy. J Neurosurg Spine. 2020 Mar 27:1-7. doi: 10.3171/2020.1.SPINE191223. Online ahead of print.
Results Reference
derived

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US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation

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