Unilateral Approach for Bilateral Decompression of Lumbar Canal Stenosis

Unilateral Decompression Approach for Lumbar Canal Stenosis

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

Study Overview

• Status: Unknown
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: unilateral laminotomy; Procedure: decompressive laminectomy

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: unilateral laminotomy; patients with lumbar canal stenosis who undergo unilateral laminotomy for bilateral decompression	Procedure: unilateral laminotomy; minimally invasive technique
Experimental: decompressive laminectomy; patients with lumbar canal stenosis who undergo decompressive laminectomy	Procedure: decompressive laminectomy; classic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
back pain	visual analog scale	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neurogenic claudication pain	distance can be walked	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): November 15, 2018

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 24, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 1, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: 29109242502338

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No