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Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

Primary Purpose

Lumbar Disc Herniation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interbody cage insertion in lumbar disc prolapse
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Interbody Cage

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with lumbar disc prolapse one or two levels.
  • Patients (age >18 and < 70 years old).
  • Patients fit for surgery.

Exclusion Criteria:

  • Patients with instability of lumbar spine.
  • Patients with degenerative diseases.
  • More than two levels
  • Patients <18 or >70 years.
  • Patients unfit for surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Simple lumbar discectomy

    Lumbar discectomy with inter vertebral cage

    Arm Description

    Outcomes

    Primary Outcome Measures

    Decrease pain after discectomy and interbody cage insertion.
    Comparison between preoperative pain with lumbar disc prolapse and posoperative pain improved after Interbody cage insertion.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 2, 2019
    Last Updated
    September 6, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04083703
    Brief Title
    Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse
    Official Title
    Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    October 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse
    Detailed Description
    Discectomy for lumbar disc herniation is one of the most common operation performed worldwide for lumbar-related symptoms. The basic principle of the various techniques is to relieve the nerve root compression induced by the herniation. Over the past 30 years, many technical improvements have decreased operative trauma by reducing incision size, thereby reducing postoperative pain and hospital stay and time off work, while improving clinical outcome. Magnification and illumination systems by microscope and endoscope have been introduced to enable minimally invasive techniques. Lumbar interbody fusion using cages has gained momentum in the recent years after approval of the cages by the FDA (United States Federal Drug Administration) for lumbar interbody insertion. The indications for this procedure remain controversial and include mechanical low back pain, degenerative disc disease, recurrent disc herniation, spondylolisthesis (grade I). In degenerative disc disease or following surgical discectomy, segmental stenosis occurs due to a combination of disc herniation, posterior osteophyte formation, facet overriding and hypertrophy and ligamentum flavum hypertrophy. All these factors combine to compromise the nerve root as it exits through the intervertebral foramen resulting in recurrent radiculopathy. In such cases, Lumbar inter body fusion using cages can open up the intervertebral foramen by maintaining or restoring disc height. On the other hand, there is considerable controversy surrounding the effectiveness of lumbar fusion for the treatment of low back pain. Among the different surgical approaches available, with or without instrumentation, none can be considered the "gold standard". The technique and results of inter body fusion were first reported by Cloward. It did not, however, gain widespread acceptance due to technical difficulties. Insertion of a rectangular bone graft makes it difficult to avoid nerve root trauma resulting in radicular deficit or irritation and dural tears. Non-union or bone graft extrusion were reported as well as bone graft collapse with subsequent segmental stenosis.In the past few years, rigid cages housing autogenous bone have become increasingly popular for the purpose of interbody fusion. Their ease of insertion has decreased the technical difficulties of the earlier Cloward approach and makes the procedure more reproducible. The rigidity of the cages also allows for the preservation of the disc space. Cages are available in a wide variety of shapes and designs, the most common being the cylindrical and rectangular wedge shaped cages.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lumbar Disc Herniation
    Keywords
    Interbody Cage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    2 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Simple lumbar discectomy
    Arm Type
    Experimental
    Arm Title
    Lumbar discectomy with inter vertebral cage
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Interbody cage insertion in lumbar disc prolapse
    Other Intervention Name(s)
    Discectomy
    Intervention Description
    Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse
    Primary Outcome Measure Information:
    Title
    Decrease pain after discectomy and interbody cage insertion.
    Description
    Comparison between preoperative pain with lumbar disc prolapse and posoperative pain improved after Interbody cage insertion.
    Time Frame
    Base line

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with lumbar disc prolapse one or two levels. Patients (age >18 and < 70 years old). Patients fit for surgery. Exclusion Criteria: Patients with instability of lumbar spine. Patients with degenerative diseases. More than two levels Patients <18 or >70 years. Patients unfit for surgery.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fahd Abdel Sabour Ahmed, Rdr
    Phone
    00201029522851
    Email
    fahdneuro4@outlook.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abdel Hai Moussa Abdel Latif, prof.
    Organizational Affiliation
    Assiut University hospital,Neurosurgery department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ahmed Elsayed Abo Kresha, Assistant Prof.
    Organizational Affiliation
    Assiut University hospital,Neurosurgery department
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Mohamed Elsayed mahmoud, Assistant Prof.
    Organizational Affiliation
    Assiut University hospital,Neurosurgery department
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/19992171
    Description
    Related Info
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/16456311
    Description
    Related Info
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3638641/
    Description
    Related Info
    URL
    https://www.europepmc.org/abstract/med/1502649
    Description
    Related Info
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/7604342
    Description
    Related Info
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/1826546
    Description
    Related Info

    Learn more about this trial

    Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

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