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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Lumbar Canal Stenosis
• Intervention / Treatment: Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression

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 Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shamel Mahmoud Mohamed, Resident; Phone Number: 01028174272; Email: shamel.15259250@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open surgical decompression	Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression; Microsurgical decompression of degenerative lumbar canal stenosis
Other: Microsurgical decompression	Procedure: Open surgical decompression in degenerative lumbar canal stenosis; Open surgical decompression in degenerative lumbar canal stenosis; Procedure: Microsurgical decompression; Microsurgical decompression of degenerative lumbar canal stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clincal evaluation by visual analogue scale back pain and leg pain	12 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: Lumbar canal stenosis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No