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.
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.
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.
- Conditions
- Lumbar Disc Herniation
- 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 group | Role | What they receive |
|---|---|---|
| Simple lumbar discectomy | Experimental | Not described Receives: Procedure: Interbody cage insertion in lumbar disc prolapse |
| Lumbar discectomy with inter vertebral cage | Experimental | Not 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.
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.
- First posted10 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahd Abdel Sabour Ahmed Mohammed, Assiut University
- Investigators
- Abdel Hai Moussa Abdel Latif, prof., Study director, Assiut University hospital,Neurosurgery departmentAhmed Elsayed Abo Kresha, Assistant Prof., Study director, Assiut University hospital,Neurosurgery departmentMohamed Elsayed mahmoud, Assistant Prof., Study director, Assiut University hospital,Neurosurgery department
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Interbody Cage Insertion in Treatment of Lumbar Disc Prolapse
- ClinicalTrials.gov ID
- NCT04083703
- Acronym / sponsor ID
- Cage in LDP
- Conditions
- Lumbar Disc Herniation
- Keywords
- Interbody Cage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple lumbar discectomy | Experimental | Procedure: Interbody cage insertion in lumbar disc prolapse |
| Lumbar discectomy with inter vertebral cage | Experimental | Procedure: Interbody cage insertion in lumbar disc prolapse |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with lumbar disc prolapse one or two levels.
- Patients (age >18 and < 70 years old).
- Patients fit for surgery.
Key exclusion criteria (5 listed)
- Patients with instability of lumbar spine.
- Patients with degenerative diseases.
- More than two levels
- Patients <18 or >70 years.
- Patients unfit for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interbody cage insertion in lumbar disc prolapseAlso: DiscectomyDiscectomy alone versus interbody cage insertion in treatment of lumbar disc proapse | Procedure or surgery | Lumbar discectomy with inter vertebral cage, Simple lumbar discectomy |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdel Hai Moussa Abdel Latif, prof. study director
Assiut University hospital,Neurosurgery department
Ahmed Elsayed Abo Kresha, Assistant Prof. study director
Assiut University hospital,Neurosurgery department
Mohamed Elsayed mahmoud, Assistant Prof. study director
Assiut University hospital,Neurosurgery department
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.