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Irrigation Endoscopic Decompression

Primary Purpose

Lumbar Spinal Canal Stenosis

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Irrigation Endoscopic Decompressive Laminotomy

About this trial

This is an interventional treatment trial for Lumbar Spinal Canal Stenosis focused on measuring IEDL, irrigation endoscopic decompressive laminotomy, irrigation endoscopic decompression, minimally invasive spine surgery, endoscopic decompression, spinal stenosis

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Segmental Instability
Lytic Spondylolisthesis

2- Predominant low back pain

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IEDL

Arm Description

Endoscopic decompression of spinal stenosis

Outcomes

Primary Outcome Measures

Oswestry Disability Index

Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling

Modified Macnab criteria

patient satisfaction, the need for medications, ability to return to activity

Secondary Outcome Measures

Time for ambulation

postoperative time required to start ambulation

Time for hospitalization

postoperative hospital stay till discharge

VAS for back pain

Pain intensity on scale from 0-10

Full Information

NCT ID

NCT02254590

First Posted

September 26, 2014

Last Updated

October 1, 2014

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02254590

Brief Title

Irrigation Endoscopic Decompression

Official Title

Irrigation Endoscopic Decompressive Laminotomy. A New Endoscopic Approach for Spinal Stenosis Decompression

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Canal Stenosis

Keywords

IEDL, irrigation endoscopic decompressive laminotomy, irrigation endoscopic decompression, minimally invasive spine surgery, endoscopic decompression, spinal stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IEDL

Arm Type

Experimental

Arm Description

Endoscopic decompression of spinal stenosis

Intervention Type

Procedure

Intervention Name(s)

Irrigation Endoscopic Decompressive Laminotomy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Oswestry Disability Index

Description

Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling

Time Frame

24 months

Title

Modified Macnab criteria

Description

patient satisfaction, the need for medications, ability to return to activity

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Time for ambulation

Description

postoperative time required to start ambulation

Time Frame

72 hours

Title

Time for hospitalization

Description

postoperative hospital stay till discharge

Time Frame

72 hours

Title

VAS for back pain

Description

Pain intensity on scale from 0-10

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Neurogenic claudication or radicular leg pain with or without back pain, and/or a neurological deficit Symptoms and signs correlating with moderate to severe spinal canal stenosis as shown on MRI. (Degenerative and congenital bony stenosis were included) Failure of 3 months conservative treatment Grade I degenerative spondylolisthesis and degenerative scoliosis Exclusion Criteria: Segmental Instability Lytic Spondylolisthesis 2- Predominant low back pain

12. IPD Sharing Statement

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Irrigation Endoscopic Decompression

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