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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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.

Shamel Mahmoud Mohamed, Resident contact

01028174272

shamel.15259250@med.aun.edu.eg

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.

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 groups in NCT06722859
Study groupRoleWhat they receive
Open surgical decompressionOtherNot described
Receives: Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression
Microsurgical decompressionOtherNot 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.

  1. 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.

  1. First posted9 Dec 2024
  2. Study startDec 2024 (estimated)
  3. Primary completionSep 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

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)
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

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