Degenerative Lumbar Canal StenosisNCT06722859
Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine
A study testing Open surgical decompression in degenerative lumbar canal stenosis and Microsurgical decompression in people with Degenerative Lumbar Canal Stenosis, run by Assiut University.
Trial summary
To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Lumbar Canal Stenosis
- What is being tested?
- Open surgical decompression in degenerative lumbar canal stenosis and Microsurgical decompression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients present with degenerative lumber spinal canal stenosis in one or two level
Who cannot join
- degenrative listhesis.
- degenerative scoliosis.
- other secondary causes of lumber canal stenosis as tumor , abscesses and infection.
- Patients with previous lumbar operation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine in Assuit University Hospital
To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
Read the detailed description
Lumbar spinal stenosis is defined as a circumscribed, osteoligamentous narrowing of the spinal canal. The clinical burden includes backaches and symptoms in the legs that deteriorate upon standing and walking (neurogenic claudication). Lumbar spinal stenosis is the most common cause of lumbar spine diseases in patients > 65 years old requiring surgical treatment; it is estimated that ∼0.1% of the population will need some procedure to treat degenerative lumbar spine conditions. Surgical treatment for lumbar spinal stenosis is indicated in cases of conservative treatment failure. It is also indicated in cases with very acute symptoms and radicular involvement associated with dermatome sensorial and motor changes and progressive worsening of severe neurogenic claudication. Vertebral canal decompression can be performed with several techniques. The gold standard is the open technique with laminectomy or laminotomy, in which laminae are resected or opened; next, the ligamentum flavum, usually thickened, is resected, exposing the nervous structures under compression. Laminotomy can be unilateral, bilateral or divide the spinous process. Damaging the paraspinal muscles and liberal removal of posterior bone may cause iatrogenic spinal instability. The Microsurgical spinal canal decompression decreases paravertebral musculature injury, reducing postoperative complications related to hematomas, seromas and infections and trunk extensor musculature atrophy. The dural sac is decompressed after its exposure and removed to allow the resection of the lateral recess and foramen opening to decompress an adjacent and/or emerging nerve root. It is believed that MIS may limit surgery-related morbidity and mortality by reducing the degree of surgical trauma while maintaining similar surgical outcomes.
- Conditions
- Degenerative Lumbar Canal Stenosis
- Being tested
- Open surgical decompression in degenerative lumbar canal stenosis, Microsurgical decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open surgical decompression in degenerative lumbar canal stenosisProcedure or surgery
Open surgical decompression in degenerative lumbar canal stenosis
Microsurgical decompressionProcedure or surgery
Microsurgical decompression of degenerative lumbar canal stenosis
| Study group | Role | What they receive |
|---|---|---|
| Open surgical decompression | Other | Not described Receives: Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression |
| Microsurgical decompression | Other | Not described Receives: Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clincal evaluation by visual analogue scale back pain and leg pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Canal 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
- Model description
- To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamel Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722859
- Sponsor's protocol ID
- Lumbar canal stenosis
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT06722859
- Acronym / sponsor ID
- Lumbar canal stenosis
- Conditions
- Degenerative Lumbar Canal Stenosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
Detailed description
Lumbar spinal stenosis is defined as a circumscribed, osteoligamentous narrowing of the spinal canal. The clinical burden includes backaches and symptoms in the legs that deteriorate upon standing and walking (neurogenic claudication). Lumbar spinal stenosis is the most common cause of lumbar spine diseases in patients > 65 years old requiring surgical treatment; it is estimated that ∼0.1% of the population will need some procedure to treat degenerative lumbar spine conditions. Surgical treatment for lumbar spinal stenosis is indicated in cases of conservative treatment failure. It is also indicated in cases with very acute symptoms and radicular involvement associated with dermatome sensorial and motor changes and progressive worsening of severe neurogenic claudication. Vertebral canal decompression can be performed with several techniques. The gold standard is the open technique with laminectomy or laminotomy, in which laminae are resected or opened; next, the ligamentum flavum, usually thickened, is resected, exposing the nervous structures under compression. Laminotomy can be unilateral, bilateral or divide the spinous process. Damaging the paraspinal muscles and liberal removal of posterior bone may cause iatrogenic spinal instability. The Microsurgical spinal canal decompression decreases paravertebral musculature injury, reducing postoperative complications related to hematomas, seromas and infections and trunk extensor musculature atrophy. The dural sac is decompressed after its exposure and removed to allow the resection of the lateral recess and foramen opening to decompress an adjacent and/or emerging nerve root. It is believed that MIS may limit surgery-related morbidity and mortality by reducing the degree of surgical trauma while maintaining similar surgical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine
| Arm | Type | Receives |
|---|---|---|
| Open surgical decompression | Other | Procedure: Open surgical decompression in degenerative lumbar canal stenosis, Procedure: Microsurgical decompression |
| Microsurgical decompression | Other | Procedure: Open surgical decompression in degenerative lumbar canal stenosis, Procedure: Microsurgical decompression |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients present with degenerative lumber spinal canal stenosis in one or two level
Key exclusion criteria (4 listed)
- degenrative listhesis.
- degenerative scoliosis.
- other secondary causes of lumber canal stenosis as tumor , abscesses and infection.
- Patients with previous lumbar operation
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 |
|---|---|---|
| Open surgical decompression in degenerative lumbar canal stenosisOpen surgical decompression in degenerative lumbar canal stenosis | Procedure or surgery | Microsurgical decompression, Open surgical decompression |
| Microsurgical decompressionMicrosurgical decompression of degenerative lumbar canal stenosis | Procedure or surgery | Microsurgical decompression, Open surgical decompression |
Primary outcome
Clincal evaluation by visual analogue scale back pain and leg pain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Open surgical decompression in degenerative lumbar canal stenosis and Microsurgical decompression in people with Degenerative Lumbar Canal 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 1 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: opening soon, as of the sponsor's last update on 9 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shamel Mahmoud Mohamed, Resident (01028174272, shamel.15259250@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clincal evaluation by visual analogue scale back pain and leg pain (time frame: 12 months). 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 9 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.