Percutaneous Rupture of Zygapophyseal Joint Cysts

NCT ID: NCT00837070

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-01-31

Brief Summary

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Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture

Detailed Description

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Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture.

30 patient with lower extremity radiculopathy caused by lumbar zygapophyseal joint cysts will be included in the study.

Conditions

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Zygapophyseal Synovial Joint Cyst

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Percutaneous zygapophyseal cyst rupture

Group Type EXPERIMENTAL

Percutaneous zygapophyseal cyst rupture

Intervention Type PROCEDURE

Patients will be treated by introducing a 20G spinal needle in the inferior joint recess of the zygapophyseal joint.1 ml of celestone-chronodose,1 ml of Marcain 5 mg/ml and 1-3 ml of contrast media:Omnipaque 240 will be injected until the cyst ruptures.

Interventions

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Percutaneous zygapophyseal cyst rupture

Patients will be treated by introducing a 20G spinal needle in the inferior joint recess of the zygapophyseal joint.1 ml of celestone-chronodose,1 ml of Marcain 5 mg/ml and 1-3 ml of contrast media:Omnipaque 240 will be injected until the cyst ruptures.

Intervention Type PROCEDURE

Other Intervention Names

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Axiom Artis Siemens

Eligibility Criteria

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Inclusion Criteria

* Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI.

Exclusion Criteria

* Infection, uncontrollable bleeding disorder
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Therese Seierstad

Head of Research, Division for Radiology and Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Øivind Gjertsen, Md, Msc

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Departement of Neuroradiology Oslo university hospital avd Ullevaal

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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264-07111a 2007.345

Identifier Type: -

Identifier Source: org_study_id