Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

Not Applicable

• Conditions: Lumbar Spinal Stenosis
• Interventions: Procedure: decompressive laminectomy; Procedure: unilateral laminotomy

• Registration Number: NCT03388307
• Lead Sponsor: Assiut University

Brief Summary

The purpose of this study was to compare standard open laminectomy with ULBD approach in regard to efficiency, safety, and clinical outcome.

Detailed Description

Lumbar stenosis is one of the common spinal pathologies; it presents with back pain, leg pain, and neurogenic claudication . Although different surgical modalities are available, the main objective of the operation is decompression of nerve roots and the spinal cord.

Minimally invasive surgical procedures and microsurgical unilateral laminotomy with bilateral spinal canal decompression (ULBD) have been reported to achieve this goal .

The objective of lumbar decompression is to decompress the neural elements while preserving stability and the spinous processes.

The object of this study is to compare outcomes following minimally invasive unilateral laminectomy for bilateral decompression (ULBD) to a standard "open" laminectomy for LSS.

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-01
• Study First Posted: 2018-01-02
• Last Update Posted: 2018-01-03
• Study Start: 2018-01-15
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. age:40-80 years
2. sex:both sexes
3. symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
4. radiologically confirmed LSS , caused by degenerative changes
5. canal stenosis at a maximum of 2 levels

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Exclusion Criteria

1. were to undergo a concomitant fusion or instrumentation placement;
2. had had previous lumbar surgeries at the same level;
3. had spondylolisthesis of any grade or degenerative scoliosis;
4. had evidence of instability on dynamic radiographs.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
decompressive laminectomy	decompressive laminectomy	patients with lumbar canal stenosis who undergo decompressive laminectomy
unilateral laminotomy	unilateral laminotomy	patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression

Primary Outcome Measures

Name	Time	Method
back pain	one year	visual analog scale

Secondary Outcome Measures

Name	Time	Method
neurogenic claudication pain	one year	distance can be walked