Clinical Trials Directory

Trials / Unknown

UnknownNCT04083703

Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
2 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
17 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREInterbody cage insertion in lumbar disc prolapseDiscectomy alone versus interbody cage insertion in treatment of lumbar disc proapse

Timeline

Start date
2019-10-01
Primary completion
2020-10-01
Completion
2020-12-01
First posted
2019-09-10
Last updated
2019-09-10

Source: ClinicalTrials.gov record NCT04083703. Inclusion in this directory is not an endorsement.