Percutaneous Rupture of Zygapophyseal Joint Cysts

Zygapophyseal Synovial Joint Cyst Clinical Trial

Official title:

Percutaneous Rupture of Zygapophyseal Joint Cysts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837070
• Other study ID #: 264-07111a 2007.345
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2009
• Last updated: September 26, 2017
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: September 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Rupture
• Zygapophyseal Synovial Joint Cyst

Intervention

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.

Locations

Country	Name	City	State
Norway	Departement of Neuroradiology Oslo university hospital avd Ullevaal	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS(Visual analogue scale)for extremity pain		1-3 and 12 months after intervention
Secondary	Roland-Morris disability index		1-3 and 12 months after intervention
Secondary	Reduction of cyst size based om T2 MRI		3 and 12 months after intervention