Lumbar Spinal Canal StenosisNCT02254590
Irrigation Endoscopic Decompression
A study testing Irrigation Endoscopic Decompressive Laminotomy in people with Lumbar Spinal Canal Stenosis, run by Cairo University.
Trial summary
To evaluate a new endoscopic technique for lumbar spinal canal decompression. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Lumbar Spinal Canal Stenosis
- What is being tested?
- Irrigation Endoscopic Decompressive Laminotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2014
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit
- Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included)
- Failure of 3 months conservative treatment
- Grade I degenerative spondylolisthesis and degenerative scoliosis
Who cannot join
- Segmental Instability
- Lytic Spondylolisthesis
- 2- Predominant low back pain
About this study
Official title: Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression
To evaluate a new endoscopic technique for lumbar spinal canal decompression.
Read the detailed description
104 consecutive patients suffering of neurogenic claudication were included in the study.
Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index [19] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows
- Conditions
- Lumbar Spinal Canal Stenosis
- Being tested
- Irrigation Endoscopic Decompressive Laminotomy
- Keywords
- IEDL, irrigation endoscopic decompressive laminotomy, irrigation endoscopic decompression, minimally invasive spine surgery, endoscopic decompression, spinal stenosis
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigation Endoscopic Decompressive LaminotomyProcedure or surgery
2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.
| Study group | Role | What they receive |
|---|---|---|
| IEDL | Experimental | Endoscopic decompression of spinal stenosis Receives: Procedure: Irrigation Endoscopic Decompressive Laminotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling
Measured: 24 months
Modified Macnab criteria
patient satisfaction, the need for medications, ability to return to activity
Measured: 24 months
Secondary outcomes (3)
Time for ambulation
postoperative time required to start ambulation
Measured: 72 hours
Time for hospitalization
postoperative hospital stay till discharge
Measured: 72 hours
VAS for back pain
Pain intensity on scale from 0-10
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2009
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal Canal StenosisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hesham magdi soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254590
- Sponsor's protocol ID
- Kasr Einy
- Status last verified
- Sep 2014
- First submitted
- 26 Sep 2014
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression
- ClinicalTrials.gov ID
- NCT02254590
- Acronym / sponsor ID
- Kasr Einy
- Conditions
- Lumbar Spinal Canal Stenosis
- Keywords
- IEDL, irrigation endoscopic decompressive laminotomy, irrigation endoscopic decompression, minimally invasive spine surgery, endoscopic decompression, spinal stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Oct 2014 (estimated)
- 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.
To evaluate a new endoscopic technique for lumbar spinal canal decompression.
Detailed description
104 consecutive patients suffering of neurogenic claudication were included in the study.
Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index [19] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IEDL | Experimental | Procedure: Irrigation Endoscopic Decompressive LaminotomyEndoscopic decompression of spinal stenosis |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit
- Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included)
- Failure of 3 months conservative treatment
- Grade I degenerative spondylolisthesis and degenerative scoliosis
Key exclusion criteria (3 listed)
- Segmental Instability
- Lytic Spondylolisthesis
- 2- Predominant low back pain
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 |
|---|---|---|
| Irrigation Endoscopic Decompressive Laminotomy2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures. | Procedure or surgery | IEDL |
Primary outcome
Oswestry Disability Index
Time frame: 24 months
Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling
Modified Macnab criteria
Time frame: 24 months
patient satisfaction, the need for medications, ability to return to activity
3 secondary outcomes
Time for ambulation
Time frame: 72 hours
Time for hospitalization
Time frame: 72 hours
VAS for back pain
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
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LUMBAR STENOSIS
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigation Endoscopic Decompressive Laminotomy in people with Lumbar Spinal Canal Stenosis, run by Cairo 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 2 Oct 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: 24 months). The study lists 2 primary outcomes in all. 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 2 Oct 2014.