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Lumbar Disc HerniationNCT04083703

Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse

A study testing Interbody cage insertion in lumbar disc prolapse in people with Lumbar Disc Herniation, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Comparison between discectomy alone and interbody cage insertion in treatment of lumbar disc prolapse Read more about this study

Who is it for?
Ages 17 to 70 years
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Interbody cage insertion in lumbar disc prolapse
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
No sites listed yet
Study dates
1 Oct 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Fahd Abdel Sabour Ahmed, Rdr contact

00201029522851

fahdneuro4@outlook.com

About this study

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

Read the 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.

Being tested
Interbody cage insertion in lumbar disc prolapse
Keywords
Interbody Cage
Medical subject headings
Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interbody cage insertion in lumbar disc prolapseProcedure or surgery

    Also called Discectomy

    Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse

Study groups in NCT04083703
Study groupRoleWhat they receive
Simple lumbar discectomyExperimentalNot described
Receives: Procedure: Interbody cage insertion in lumbar disc prolapse
Lumbar discectomy with inter vertebral cageExperimentalNot described
Receives: Procedure: Interbody cage insertion in lumbar disc prolapse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease pain after discectomy and interbody cage insertion.

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

    Measured: Base line

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2019
  2. Study start1 Oct 2019 (estimated)
  3. Primary completion1 Oct 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
2 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04083703
Sponsor's protocol ID
Cage in LDP
Status last verified
Sep 2019
First submitted
2 Sep 2019
Last updated
10 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Interbody cage insertion in lumbar disc prolapse in people with Lumbar Disc Herniation, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fahd Abdel Sabour Ahmed, Rdr (00201029522851, fahdneuro4@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease pain after discectomy and interbody cage insertion. (time frame: Base line). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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