MedDataX Logo

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

NCT ID: NCT06722859

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Degenerative Lumbar Canal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open surgical decompression

Group Type OTHER

Open surgical decompression in degenerative lumbar canal stenosis

Intervention Type PROCEDURE

Open surgical decompression in degenerative lumbar canal stenosis

Microsurgical decompression

Intervention Type PROCEDURE

Microsurgical decompression of degenerative lumbar canal stenosis

Microsurgical decompression

Group Type OTHER

Open surgical decompression in degenerative lumbar canal stenosis

Intervention Type PROCEDURE

Open surgical decompression in degenerative lumbar canal stenosis

Microsurgical decompression

Intervention Type PROCEDURE

Microsurgical decompression of degenerative lumbar canal stenosis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open surgical decompression in degenerative lumbar canal stenosis

Open surgical decompression in degenerative lumbar canal stenosis

Intervention Type PROCEDURE

Microsurgical decompression

Microsurgical decompression of degenerative lumbar canal stenosis

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shamel Mahmoud

Resident of orthopedic and trauma surgery Assiut university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shamel Mahmoud Mohamed, Resident

Role: CONTACT

Phone: 01028174272

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lumbar canal stenosis

Identifier Type: -

Identifier Source: org_study_id