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Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

A

Assiut University

Status

Unknown

Conditions

Lumbar Spinal Stenosis

Treatments

Procedure: decompressive laminectomy
Procedure: unilateral laminotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03388307
29109242502338

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

unilateral laminotomy
Experimental group
Description:
patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression
Treatment:
Procedure: unilateral laminotomy
decompressive laminectomy
Experimental group
Description:
patients with lumbar canal stenosis who undergo decompressive laminectomy
Treatment:
Procedure: decompressive laminectomy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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