Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

September 6, 2019 updated by: Fahd Abdel Sabour Ahmed Mohammed, Assiut University
Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simple lumbar discectomy
Procedure: Interbody cage insertion in lumbar disc prolapse
Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse
Other Names:
  • Discectomy
EXPERIMENTAL: Lumbar discectomy with inter vertebral cage
Procedure: Interbody cage insertion in lumbar disc prolapse
Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse
Other Names:
  • Discectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease pain after discectomy and interbody cage insertion.
Time Frame: Base line
Comparison between preoperative pain with lumbar disc prolapse and posoperative pain improved after Interbody cage insertion.
Base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Abdel Hai Moussa Abdel Latif, prof., Assiut University hospital,Neurosurgery department
  • Study Director: Ahmed Elsayed Abo Kresha, Assistant Prof., Assiut University hospital,Neurosurgery department
  • Study Director: Mohamed Elsayed mahmoud, Assistant Prof., Assiut University hospital,Neurosurgery department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2019

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 6, 2019

First Posted (ACTUAL)

September 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 6, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cage in LDP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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