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Percutaneous Rupture of Zygapophyseal Joint Cysts

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00837070
First received: February 4, 2009
Last updated: March 2, 2010
Last verified: January 2009
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Percutaneous Rupture of Zygapophyseal Joint Cysts

Further study details as provided by Ullevaal University Hospital:

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

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

Estimated Enrollment: 30
Study Start Date: January 2009
Estimated Study Completion Date: January 2012
Estimated 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837070

Contacts
Contact: Øivind Gjertsen, MD, Msc +4792663236 ext +47 gjei@uus.no
Contact: Per Hj Nakstad, Phd +4722118080 ext +47 pena@uus.no

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

No publications provided

Responsible Party: Dr. Øivind Gjertsen, Ullevål university hospital
ClinicalTrials.gov Identifier: NCT00837070     History of Changes
Other Study ID Numbers: 264-07111a 2007.345
Study First Received: February 4, 2009
Last Updated: March 2, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Zygapophyseal
joint
cyst
Fluoroscopy
 guided
percutaneous
Lumbar

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

ClinicalTrials.gov processed this record on May 19, 2013