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OpenTrials
Completed

NCT Number: NCT02254590

Irrigation Endoscopic Decompression

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

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Key information

Conditions

Lumbar Spinal Canal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irrigation Endoscopic Decompressive Laminotomy

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.

Primary outcomes

  1. Oswestry Disability Index

    Time frame: 24 months

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

  2. Modified Macnab criteria

    Time frame: 24 months

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

Secondary outcomes

  1. Time for ambulation

    Time frame: 72 hours

    postoperative time required to start ambulation

  2. Time for hospitalization

    Time frame: 72 hours

    postoperative hospital stay till discharge

  3. VAS for back pain

    Time frame: 72 hours

    Pain intensity on scale from 0-10

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 2, 2014
Registry last updated
Oct 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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