Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation
Primary Purpose
Lumbar Herniated Disc
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Percutaneous transforaminal endoscopic discectomy (PTED)
Microendoscopic discectomy (MED)
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Herniated Disc
Eligibility Criteria
Inclusion Criteria:
- Persistent radicular pain.
- Signs including evidence of nerve root compression with a positive nerve root tension sign (straight leg raising test or femoral tension sign) or a corresponding sign of neurological deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution).
- An imaging study (MRI or CT) showing LDH at a level and side corresponding to the patients radicular signs or symptoms.
Exclusion Criteria:
- <18 or >65 years of age
- Insufficient conservative treatment (6 weeks)
- 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
- High-grade migrated disc herniation
- Previous spinal surgery
- Possible pregnancy or other comorbid conditions contraindicating surgery
Sites / Locations
- the Third Affiliated Hospital of Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Transforaminal discectomy
Microendoscopic discectomy
Arm Description
patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED).
Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED).
Outcomes
Primary Outcome Measures
Changes in pain and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI)
Secondary Outcome Measures
Changes in health-related quality of life as measured by the EQ-5D,Visual Analog Scale (VAS) and the SF-36 health status questionnaire, and the radiological changes in spine as measured by x-ray, CT or MRI.
Histological analysis of surgical lumbar intervertebral disc tissue
Full Information
NCT ID
NCT01997086
First Posted
November 14, 2013
Last Updated
April 19, 2017
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT01997086
Brief Title
Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation
Official Title
Percutaneous Transforaminal Endoscopic Discectomy (PTED) Versus Microendoscopic Discectomy (MED) for the Treatment of Lumbar Disc Herniation: A Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic 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) and microendoscopic discectomy (MED) are two widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. As difference in operative approaches and iatrogenic injury, the clinical outcome might be dramatically different from each other.
In this study, a single center randomized controlled trial will be performed to evaluate the effectiveness of two minimal invasive endoscopic discectomy, PTED and MED, for the treatment of symptomatic LDH. We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.
Two groups of patients will be investigated; 1) patients diagnosed with lumbar disc herniation undergoing PTED, and 2) patients diagnosed with lumbar disc herniation undergoing MED.
The primary outcomes of the study will be score of Oswestry Disability Index (ODI) as measured at pre- and post-operation, 1 month, 3 months, 6 months, and annually thereafter. Secondary outcomes include Visual Analog Scale (VAS), the SF-36 Health Survey, as well as post-operative radiological assessment. Treatment effect is defined as the difference in the mean change from baseline between the two groups. Lumbar intervertebral disc tissue would be obtained during surgery for histological analysis, in order to evaluate disc degeneration and find out risk factors of it.
On the basis of the results of this trial we will, for the first time, have scientific evidence as to the relative effectiveness of PTED versus MED for minimal invasive surgical treatment for symptomatic 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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
125 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transforaminal discectomy
Arm Type
Active Comparator
Arm Description
patients diagnosed as lumbar disc herniation undergoing percutaneous transforaminal endoscopic discectomy (PTED).
Arm Title
Microendoscopic discectomy
Arm Type
Active Comparator
Arm Description
Patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy (MED).
Intervention Type
Procedure
Intervention Name(s)
Percutaneous transforaminal endoscopic discectomy (PTED)
Intervention Description
Percutaneous transforaminal endoscopic discectomy
Intervention Type
Procedure
Intervention Name(s)
Microendoscopic discectomy (MED)
Intervention Description
Microendoscopic discectomy
Primary Outcome Measure Information:
Title
Changes in pain and functional status as measured by Oswestry Low Back Disability Questionnaire (Oswestry Disability Index,ODI)
Time Frame
Baseline, post-operation, 1 month, 3 months, 6 months, and annually thereafter
Secondary Outcome Measure Information:
Title
Changes in health-related quality of life as measured by the EQ-5D,Visual Analog Scale (VAS) and the SF-36 health status questionnaire, and the radiological changes in spine as measured by x-ray, CT or MRI.
Time Frame
Baseline, post-op 1 month, 3 months, 6 months, and annually thereafter.
Title
Histological analysis of surgical lumbar intervertebral disc tissue
Time Frame
postoperation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persistent radicular pain.
Signs including evidence of nerve root compression with a positive nerve root tension sign (straight leg raising test or femoral tension sign) or a corresponding sign of neurological deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution).
An imaging study (MRI or CT) showing LDH at a level and side corresponding to the patients radicular signs or symptoms.
Exclusion Criteria:
<18 or >65 years of age
Insufficient conservative treatment (6 weeks)
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
High-grade migrated disc herniation
Previous spinal surgery
Possible pregnancy or other comorbid conditions contraindicating surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Rong, M.D.
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36114871
Citation
Chen Z, He L, Di J, Huang L, Feng F, Yang B, Xie P, Rong L. Lumbar facet joint osteoarthritis as the underlying reason for persistent low back pain after minimally invasive discectomy. Arch Orthop Trauma Surg. 2023 Jul;143(7):3811-3821. doi: 10.1007/s00402-022-04595-y. Epub 2022 Sep 17.
Results Reference
derived
PubMed Identifier
35378590
Citation
Chen Z, He L, Huang L, Liu Z, Dong J, Liu B, Chen R, Zhang L, Xie P, Rong L. Risk Factors for Poor Outcomes Following Minimally Invasive Discectomy: A Post Hoc Subgroup Analysis of 2-Year Follow-up Prospective Data. Neurospine. 2022 Mar;19(1):224-235. doi: 10.14245/ns.2143084.542. Epub 2022 Mar 31.
Results Reference
derived
PubMed Identifier
29303469
Citation
Chen Z, Zhang L, Dong J, Xie P, Liu B, Wang Q, Chen R, Feng F, Yang B, Shu T, Li S, Yang Y, He L, Pang M, Rong L. Percutaneous transforaminal endoscopic discectomy compared with microendoscopic discectomy for lumbar disc herniation: 1-year results of an ongoing randomized controlled trial. J Neurosurg Spine. 2018 Mar;28(3):300-310. doi: 10.3171/2017.7.SPINE161434. Epub 2018 Jan 5.
Results Reference
derived
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Percutaneous Transforaminal Endoscopic Discectomy vs Microendoscopic Discectomy for Treatment of Lumbar Disc Herniation
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