Lumbar Spinal StenosisNCT03388307
Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
A study testing unilateral laminotomy and decompressive laminectomy in people with Lumbar Spinal Stenosis, run by Assiut University.
Trial summary
The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- unilateral laminotomy and decompressive laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2018to 15 Nov 2018
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age:40-80 years
- sex:both sexes
- symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
- radiologically confirmed LSS , caused by degenerative changes
- canal stenosis at a maximum of 2 levels
Who cannot join
- were to undergo a concomitant fusion or instrumentation placement;
- had had previous lumbar surgeries at the same level;
- had spondylolisthesis of any grade or degenerative scoliosis;
- had evidence of instability on dynamic radiographs.
About this study
Official title: Unilateral Decompression Approach for Lumbar Canal Stenosis
The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.
Read the detailed description
Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord.
Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal .
The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes.
The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- unilateral laminotomy, decompressive laminectomy
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral laminotomyProcedure or surgery
minimally invasive technique
decompressive laminectomyProcedure or surgery
classic surgery
| Study group | Role | What they receive |
|---|---|---|
| unilateral laminotomy | Experimental | patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression Receives: Procedure: unilateral laminotomy |
| decompressive laminectomy | Experimental | patients with lumbar canal stenosis who undergo decompressive laminectomy Receives: Procedure: decompressive laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
back pain
visual analog scale
Measured: one year
Secondary outcomes (1)
neurogenic claudication pain
distance can be walked
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start15 Jan 2018 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion15 Nov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed esam mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388307
- Sponsor's protocol ID
- 29109242502338
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2017
- Last updated
- 3 Jan 2018
- 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 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Decompression Approach for Lumbar Canal Stenosis
- ClinicalTrials.gov ID
- NCT03388307
- Acronym / sponsor ID
- 29109242502338
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 15 Nov 2018 (estimated)
- First posted
- 2 Jan 2018 (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.
The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.
Detailed description
Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord.
Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal .
The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes.
The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral laminotomy | Experimental | Procedure: unilateral laminotomypatients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression |
| decompressive laminectomy | Experimental | Procedure: decompressive laminectomypatients with lumbar canal stenosis who undergo decompressive laminectomy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age:40-80 years
- sex:both sexes
- symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
- radiologically confirmed LSS , caused by degenerative changes
- canal stenosis at a maximum of 2 levels
Key exclusion criteria (4 listed)
- were to undergo a concomitant fusion or instrumentation placement;
- had had previous lumbar surgeries at the same level;
- had spondylolisthesis of any grade or degenerative scoliosis;
- had evidence of instability on dynamic radiographs.
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 |
|---|---|---|
| unilateral laminotomyminimally invasive technique | Procedure or surgery | unilateral laminotomy |
| decompressive laminectomyclassic surgery | Procedure or surgery | decompressive laminectomy |
Primary outcome
back pain
Time frame: one year
visual analog scale
1 secondary outcome
neurogenic claudication pain
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
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 unilateral laminotomy and decompressive laminectomy in people with Lumbar Spinal Stenosis, 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 5 inclusion and 4 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 3 Jan 2018. 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?
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?
back pain (time frame: one year). 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 3 Jan 2018.