NCT00837070

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

September 28, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

February 4, 2009

Last Update Submit

September 26, 2017

Conditions

Zygapophyseal Synovial Joint Cyst

Keywords

ZygapophysealjointcystFluoroscopyguidedpercutaneousLumbar

Outcome Measures

Primary Outcomes (1)

  • VAS(Visual analogue scale)for extremity pain

    1-3 and 12 months after intervention

Secondary Outcomes (2)

  • Roland-Morris disability index

    1-3 and 12 months after intervention

  • Reduction of cyst size based om T2 MRI

    3 and 12 months after intervention

Study Arms (1)

1

EXPERIMENTAL

Percutaneous zygapophyseal cyst rupture

Procedure: Percutaneous zygapophyseal cyst rupture

Interventions

Percutaneous zygapophyseal cyst rupturePROCEDURE

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.

Also known as: Axiom Artis Siemens
1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Infection, uncontrollable bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of Neuroradiology Oslo university hospital avd Ullevaal

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Cysts

Condition Hierarchy (Ancestors)

NeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Øivind Gjertsen, Md, Msc

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Division for Radiology and Nuclear Medicine

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2012

Last Updated

September 28, 2017

Record last verified: 2017-09

Locations

NO(1)