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
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