Irrigation Endoscopic Decompression

Lumbar Spinal Canal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254590
• Other study ID #: Kasr Einy
• Status: Completed
• Phase: N/A
• First received: September 26, 2014
• Last updated: October 1, 2014
• Start date: September 2009
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Cairo University
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Exclusion Criteria:

1. Segmental Instability

2. Lytic Spondylolisthesis

2- Predominant low back pain

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Canal Stenosis
• Spinal Stenosis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index	Measurement of pain intensity, personal care, sitting, standing, walking, lifting,sleeping, sex life, social life, travelling	24 months	No
Primary	Modified Macnab criteria	patient satisfaction, the need for medications, ability to return to activity	24 months	No
Secondary	Time for ambulation	postoperative time required to start ambulation	72 hours	No
Secondary	Time for hospitalization	postoperative hospital stay till discharge	72 hours	No
Secondary	VAS for back pain	Pain intensity on scale from 0-10	72 hours	No