NCT01991912

Brief Summary

The classic laminectomy for surgical treatment of spinal stenosis has considerable morbidity .This is further magnified by the disease being more common in elderly with associated medical comorbidities and being usually global involving multiple levels.The purpose of this study is to present and to evaluate a new endoscopic technique named Irrigation Endoscopic Decompressive Laminotomy (IEDL) for lumbar spinal canal decompression.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
Last Updated

January 29, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

June 7, 2013

Last Update Submit

January 28, 2014

Conditions

Lumbosacral Spinal Stenosis

Keywords

irrigation endoscopic decompressionminimally invasive surgeryspinal stenosis

Outcome Measures

Primary Outcomes (1)

  • oswestry disability index

    24 months

Secondary Outcomes (3)

  • postoperative hospital stay

    30 days

  • time required following surgery before return to work

    30 days

  • vas for back pain

    30 days

Other Outcomes (1)

  • complications

    24 months

Study Arms (1)

irrigation endoscopic decompression

EXPERIMENTAL

endoscopic decompression is performed for cases of lumbar spinal stenosis.Portals 0.5cm in size are used for the introduction of the instruments and the endoscope. Saline under pump pressure is used to open a potential working space. This is followed by performing an ipsilateral hemilaminotomy and contralateral decompression under the midline structure

Procedure: open lumbar decompression

Interventions

open lumbar decompressionPROCEDURE

A posterior midline incision is performed over the affected levels. Bilateral subperiosteal dissection of the paraspinal muscles is performed. Bilateral hemilaminotomies, foraminotomies and lateral recess decompression is performed followed by wound closure

irrigation endoscopic decompression

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • neurogenic claudication,that correlated with moderate to severe spinal canal stenosis as shown on MRI and resistant to 3 months of conservative management .

You may not qualify if:

  • predominant back pain or instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • hesham m soliman, MD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

June 7, 2013

First Posted

November 25, 2013

Study Start

June 1, 2009

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

January 29, 2014

Record last verified: 2014-01