Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2018-11-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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unilateral laminotomy

patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression

Group Type EXPERIMENTAL

unilateral laminotomy

Intervention Type PROCEDURE

minimally invasive technique

decompressive laminectomy

patients with lumbar canal stenosis who undergo decompressive laminectomy

Group Type EXPERIMENTAL

decompressive laminectomy

Intervention Type PROCEDURE

classic surgery

Interventions

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unilateral laminotomy

minimally invasive technique

Intervention Type PROCEDURE

decompressive laminectomy

classic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No