Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

Lumbar Disc Herniation Clinical Trial

Official title:

Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04083703
• Other study ID #: Cage in LDP
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Fahd Abdel Sabour Ahmed, Rdr
• Phone: 00201029522851
• Email: fahdneuro4[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2
• Est. completion date: December 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Prolapse

Intervention

Procedure:
• Interbody cage insertion in lumbar disc prolapse
Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease pain after discectomy and interbody cage insertion.	Comparison between preoperative pain with lumbar disc prolapse and posoperative pain improved after Interbody cage insertion.	Base line

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