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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02254590
Other study ID # Kasr Einy
Secondary ID
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


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