Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
Primary Purpose
Lumbar Spinal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
unilateral laminotomy
decompressive laminectomy
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- age:40-80 years
- sex:both sexes
- symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
- radiologically confirmed LSS , caused by degenerative changes
- canal stenosis at a maximum of 2 levels
Exclusion Criteria:
- were to undergo a concomitant fusion or instrumentation placement;
- had had previous lumbar surgeries at the same level;
- had spondylolisthesis of any grade or degenerative scoliosis;
- had evidence of instability on dynamic radiographs.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
unilateral laminotomy
decompressive laminectomy
Arm Description
patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression
patients with lumbar canal stenosis who undergo decompressive laminectomy
Outcomes
Primary Outcome Measures
back pain
visual analog scale
Secondary Outcome Measures
neurogenic claudication pain
distance can be walked
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03388307
Brief Title
Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
Official Title
Unilateral Decompression Approach for Lumbar Canal Stenosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2018 (Anticipated)
Primary Completion Date
November 1, 2018 (Anticipated)
Study Completion Date
November 15, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
unilateral laminotomy
Arm Type
Experimental
Arm Description
patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression
Arm Title
decompressive laminectomy
Arm Type
Experimental
Arm Description
patients with lumbar canal stenosis who undergo decompressive laminectomy
Intervention Type
Procedure
Intervention Name(s)
unilateral laminotomy
Intervention Description
minimally invasive technique
Intervention Type
Procedure
Intervention Name(s)
decompressive laminectomy
Intervention Description
classic surgery
Primary Outcome Measure Information:
Title
back pain
Description
visual analog scale
Time Frame
one year
Secondary Outcome Measure Information:
Title
neurogenic claudication pain
Description
distance can be walked
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age:40-80 years
sex:both sexes
symptomatic LSS with radiculopathy , neurogenic claudication , or urinary dysfunction.
radiologically confirmed LSS , caused by degenerative changes
canal stenosis at a maximum of 2 levels
Exclusion Criteria:
were to undergo a concomitant fusion or instrumentation placement;
had had previous lumbar surgeries at the same level;
had spondylolisthesis of any grade or degenerative scoliosis;
had evidence of instability on dynamic radiographs.
12. IPD Sharing Statement
Learn more about this trial
Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis
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