search
Back to results

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
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All forms of disc herniation were included in the study
  2. History of concordant radicular leg pain refractory to conservative treatment for longer than 6 months
  3. Leg pain must be greater than back pain

Exclusion Criteria:

  1. cauda equine syndrome,
  2. progressive neurologic deficit,
  3. bilateral lower extremity symptoms,
  4. low back pain more than leg pain
  5. Systemic infection or localized infection at the anticipated entry needle site
  6. combined with lumbar infection, fracture of lumbar vertebra, tumor, Ⅱ°and above spondylolisthesis, lumbar spinal stenosis, lumbar scoliosis is larger than 15 degree
  7. with severe heart, brain, lungs, and other organs disease or mental illness
  8. History of opioid abuse or patients currently on long acting opioid
  9. History of the operation on lumbar
  10. 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

    First Posted
    January 26, 2015
    Last Updated
    February 6, 2015
    Sponsor
    Southeast University, China
    search

    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

    Learn more about this trial

    Microendoscopic Discectomy Vs Transforaminal Endoscopic Lumbar Discectomy Vs Open Discectomy

    We'll reach out to this number within 24 hrs