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Percutaneous Rupture of Zygapophyseal Joint Cysts

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837070
First Posted: February 5, 2009
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Therese Seierstad, Oslo University Hospital
  Purpose
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture

Condition Intervention Phase
Zygapophyseal Synovial Joint Cyst Procedure: Percutaneous zygapophyseal cyst rupture Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Rupture of Zygapophyseal Joint Cysts

Resource links provided by NLM:


Further study details as provided by Therese Seierstad, Oslo University Hospital:

Primary Outcome Measures:
  • VAS(Visual analogue scale)for extremity pain [ Time Frame: 1-3 and 12 months after intervention ]

Secondary Outcome Measures:
  • Roland-Morris disability index [ Time Frame: 1-3 and 12 months after intervention ]
  • Reduction of cyst size based om T2 MRI [ Time Frame: 3 and 12 months after intervention ]

Enrollment: 26
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Percutaneous zygapophyseal cyst rupture
Procedure: 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.
Other Name: Axiom Artis Siemens

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837070


Locations
Norway
Departement of Neuroradiology Oslo university hospital avd Ullevaal
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Øivind Gjertsen, Md, Msc Oslo University Hospital
  More Information

Responsible Party: Therese Seierstad, Head of Research, Division for Radiology and Nuclear Medicine, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00837070     History of Changes
Other Study ID Numbers: 264-07111a 2007.345
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: September 28, 2017
Last Verified: September 2017

Keywords provided by Therese Seierstad, Oslo University Hospital:
Zygapophyseal
joint
cyst
Fluoroscopy
guided
percutaneous
Lumbar

Additional relevant MeSH terms:
Rupture
Cysts
Wounds and Injuries
Neoplasms
Pathological Conditions, Anatomical