Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy
1 other identifier
interventional
240
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2015
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedFebruary 9, 2015
February 1, 2015
2 years
January 26, 2015
February 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
up to 104 weeks
Secondary Outcomes (3)
visual analogue scale(VAS)
up to 104 weeks
The generic health survey on the Short Form-36(SF-36)
up to 104 weeks
Complications survey
up to 104 weeks
Study Arms (3)
open discectomy
ACTIVE COMPARATORpatients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD)
microendoscopic discectomy
ACTIVE COMPARATORpatients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED)
transforaminal endoscopic discectomy
ACTIVE COMPARATORpatients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD)
Interventions
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.
Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.
transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 19830485RESULTWu 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.
PMID: 17077737RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Wu Xiaotao, MD
Zhangda hospital,Southeast university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kun Wang
Study Record Dates
First Submitted
January 26, 2015
First Posted
February 6, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
February 9, 2015
Record last verified: 2015-02