Back to results

Percutaneous Rupture of Zygapophyseal Joint Cysts

Primary Purpose

Zygapophyseal Synovial Joint Cyst

Status

Completed

Phase

Phase 2

Locations

Norway

Study Type

Interventional

Intervention

Percutaneous zygapophyseal cyst rupture

About this trial

This is an interventional treatment trial for Zygapophyseal Synovial Joint Cyst focused on measuring Zygapophyseal, joint, cyst, Fluoroscopy, guided, percutaneous, Lumbar

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Departement of Neuroradiology Oslo university hospital avd Ullevaal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Percutaneous zygapophyseal cyst rupture

Outcomes

Primary Outcome Measures

VAS(Visual analogue scale)for extremity pain

Secondary Outcome Measures

Roland-Morris disability index

Reduction of cyst size based om T2 MRI

Full Information

NCT ID

NCT00837070

First Posted

February 4, 2009

Last Updated

September 26, 2017

Sponsor

Ullevaal University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00837070

Brief Title

Percutaneous Rupture of Zygapophyseal Joint Cysts

Official Title

Percutaneous Rupture of Zygapophyseal Joint Cysts

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ullevaal University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Zygapophyseal Synovial Joint Cyst

Keywords

Zygapophyseal, joint, cyst, Fluoroscopy, guided, percutaneous, Lumbar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Percutaneous zygapophyseal cyst rupture

Intervention Type

Procedure

Intervention Name(s)

Percutaneous zygapophyseal cyst rupture

Other Intervention Name(s)

Axiom Artis Siemens

Intervention Description

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.

Primary Outcome Measure Information:

Title

VAS(Visual analogue scale)for extremity pain

Time Frame

1-3 and 12 months after intervention

Secondary Outcome Measure Information:

Title

Roland-Morris disability index

Time Frame

1-3 and 12 months after intervention

Title

Reduction of cyst size based om T2 MRI

Time Frame

3 and 12 months after intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Øivind Gjertsen, Md, Msc

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Departement of Neuroradiology Oslo university hospital avd Ullevaal

City

Oslo

ZIP/Postal Code

0407

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

Percutaneous Rupture of Zygapophyseal Joint Cysts

We'll reach out to this number within 24 hrs