Irrigation Endoscopic Decompression

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

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-03-31

Brief Summary

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To evaluate a new endoscopic technique for lumbar spinal canal decompression.

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Detailed Description

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104 consecutive patients suffering of neurogenic claudication were included in the study.

Patients were operated using the irrigation endoscopic decompression technique. Mean Follow up was 28 months Primary outcome measures were assessed using the Oswestry Disability Index \[19\] and the modified Macnab Criteria All statistical calculations were done using computer programs SPSS (Statistical Package for the Social Science; SPSS Inc., Chicago, IL, USA) version 15 for Microsoft Windows

Conditions

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Lumbar Spinal Canal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IEDL

Endoscopic decompression of spinal stenosis

Group Type EXPERIMENTAL

Irrigation Endoscopic Decompressive Laminotomy

Intervention Type PROCEDURE

2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.

Interventions

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Irrigation Endoscopic Decompressive Laminotomy

2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit
2. Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included)
3. Failure of 3 months conservative treatment
4. Grade I degenerative spondylolisthesis and degenerative scoliosis