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NCT Number: NCT06722859

Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine

To compare the outcomes of open and microsururgical decompression in degenerative spinal stenosis in lumbar spine

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients present with degenerative lumber spinal canal stenosis in one or two level

Exclusion criteria

  • degenrative listhesis.
  • degenerative scoliosis.
  • other secondary causes of lumber canal stenosis as tumor , abscesses and infection.
  • Patients with previous lumbar operation

Treatment and study plan

Open surgical decompression in degenerative lumbar canal stenosis

Procedure

Open surgical decompression in degenerative lumbar canal stenosis

microsurgical decompression

Procedure

Microsurgical decompression of degenerative lumbar canal stenosis

Primary outcomes

  1. Clincal evaluation by visual analogue scale back pain and leg pain

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Shamel Mahmoud Mohamed, Resident

CONTACT

[email protected]

01028174272

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison Between The Results of Open and Microsurgical Decompression in Degenerative Spinal Canal Stenosis in Lumbar Spine in Assuit University Hospital

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.