Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
Primary Purpose
Lumbar Disc Herniation
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
open discectomy
microendoscopic discectomy
transforaminal endoscopic lumbar discectomy
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Disc Herniation
Eligibility Criteria
Inclusion Criteria:
- All forms of disc herniation were included in the study
- History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months
- Leg pain must be greater than back pain
Exclusion Criteria:
- cauda equine syndrome,
- progressive neurologic deficit,
- bilateral lower extremity symptoms,
- low back pain more than leg pain
- Systemic infection or localized infection at the anticipated entry needle site
- combined with lumbar infection, fracture of lumbar vertebra, tumor, Ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree
- with severe heart, brain, lungs, and other organs disease or mental illness
- History of opioid abuse or patients currently on long acting opioid
- History of the operation on lumbar
- Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
open discectomy
microendoscopic discectomy
transforaminal endoscopic discectomy
Arm Description
patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)
patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)
patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)
Outcomes
Primary Outcome Measures
Oswestry Disability Index(ODI)
Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome
Secondary Outcome Measures
visual analogue scale(VAS)
Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome
The generic health survey on the Short Form-36(SF-36)
The scale was used to evaluate the quality of life
Complications survey
Complications of surgery including mortality and common: thrombosis; surgical site and other infections; recurrent disc herniation; dural tear; nerve root injury
Full Information
NCT ID
NCT02358291
First Posted
January 26, 2015
Last Updated
February 6, 2015
Sponsor
Southeast University, China
1. Study Identification
Unique Protocol Identification Number
NCT02358291
Brief Title
Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
Official Title
Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy for the Treatment of Lumbar Disc Herniation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southeast University, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In our study, a multicenter randomized controlled,single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation.
Detailed Description
Lumbar disc herniation (LDH) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. In spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable number of invalid patients who eventually still need to be undergoing a surgical operation treatment. Three main methods for intervertebral disc surgery are adopted in our routine work. One procedure is Open Discectomy (OD), which has been always a gold standard for treatment of LDH. And the other two procedures are Microendoscopic Discectomy (MED) and Transforaminal Endoscopic Lumbar Discectomy (TELD) respectively. MED and TELD have been developed as alternatives to OD. OD can compress the nerve root or spinal cord through removal of the protrusion. However, it destroys the rear structure of spine, causing segmental instability and long-term distress. Compared with OD, MED and TELD procedures are smaller incisions or less dissection (or both), lower blood loss, less postoperative pain, shorter hospitalisation and earlier return to work. However, the steep learning curves of MID inhibit the development of surgery specialists; for example, optimal surgical management requires many years of experience. These deficiencies need more educational effort at a higher priority than accorded so far. There are inconsistent outcomes about the efficacy and safety in the previous studies; all of the recent researches do not yield conclusive results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open discectomy
Arm Type
Active Comparator
Arm Description
patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)
Arm Title
microendoscopic discectomy
Arm Type
Active Comparator
Arm Description
patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)
Arm Title
transforaminal endoscopic discectomy
Arm Type
Active Comparator
Arm Description
patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)
Intervention Type
Procedure
Intervention Name(s)
open discectomy
Intervention Description
The open discectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.
Intervention Type
Procedure
Intervention Name(s)
microendoscopic discectomy
Intervention Description
Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.
Intervention Type
Procedure
Intervention Name(s)
transforaminal endoscopic lumbar discectomy
Intervention Description
transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen
Primary Outcome Measure Information:
Title
Oswestry Disability Index(ODI)
Description
Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome
Time Frame
up to 104 weeks
Secondary Outcome Measure Information:
Title
visual analogue scale(VAS)
Description
Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome
Time Frame
up to 104 weeks
Title
The generic health survey on the Short Form-36(SF-36)
Description
The scale was used to evaluate the quality of life
Time Frame
up to 104 weeks
Title
Complications survey
Description
Complications of surgery including mortality and common: thrombosis; surgical site and other infections; recurrent disc herniation; dural tear; nerve root injury
Time Frame
up to 104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All forms of disc herniation were included in the study
History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months
Leg pain must be greater than back pain
Exclusion Criteria:
cauda equine syndrome,
progressive neurologic deficit,
bilateral lower extremity symptoms,
low back pain more than leg pain
Systemic infection or localized infection at the anticipated entry needle site
combined with lumbar infection, fracture of lumbar vertebra, tumor, Ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree
with severe heart, brain, lungs, and other organs disease or mental illness
History of opioid abuse or patients currently on long acting opioid
History of the operation on lumbar
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Kun, PHD
Phone
+86(25)-83262331
Email
wangkunspine@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wu Xiaotao, MD
Phone
+86(25)-83262331
Email
wuxiaotao@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Xiaotao, MD
Organizational Affiliation
Zhangda hospital,Southeast university
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19830485
Citation
Liu WG, Wu XT, Guo JH, Zhuang SY, Teng GJ. Long-term outcomes of patients with lumbar disc herniation treated with percutaneous discectomy: comparative study with microendoscopic discectomy. Cardiovasc Intervent Radiol. 2010 Aug;33(4):780-6. doi: 10.1007/s00270-009-9720-6. Epub 2009 Oct 15.
Results Reference
result
PubMed Identifier
17077737
Citation
Wu X, Zhuang S, Mao Z, Chen H. Microendoscopic discectomy for lumbar disc herniation: surgical technique and outcome in 873 consecutive cases. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2689-94. doi: 10.1097/01.brs.0000244615.43199.07.
Results Reference
result
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Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
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