Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Unilateral Decompression Approach for Lumbar Canal Stenosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03388307
• Other study ID #: 29109242502338
• Status: Not yet recruiting
• Phase: N/A
• First received: December 19, 2017
• Last updated: January 1, 2018
• Start date: January 15, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 15, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• unilateral laminotomy
minimally invasive technique
• decompressive laminectomy
classic surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	back pain	visual analog scale	one year
Secondary	neurogenic claudication pain	distance can be walked	one year