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