Percutaneous Rupture of Zygapophyseal Joint Cysts | NCT00837070

Studies
Percutaneous Rupture of Zygapophyseal Joint Cysts

NCT00837070

Sponsor

Ullevaal University Hospital

Status

Completed

Last Update Posted

Sep 28, 2017Actual

Enrollment

26Actual

Phase

Phase 2

Conditions

Zygapophyseal Synovial Joint Cyst

Interventions

Percutaneous zygapophyseal cyst rupture

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 4, 2009

First Posted Date

Feb 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2017

Last Update Posted Date

Sep 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Therese Seierstad, Head of Research, Division for Radiology and Nuclear Medicine, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Ullevaal University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Percutaneous zygapophyseal cyst rupture	Procedure: Percutaneous zygapophyseal cyst rupture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous zygapophyseal cyst rupture	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS(Visual analogue scale)for extremity pain		1-3 and 12 months after intervention

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Øivind Gjertsen, Md, Msc	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement of Neuroradiology Oslo university hospital avd Ullevaal		Oslo		0407	Norway

Condition Browse Module

MeSH Terms

ID	Term
D003560	Cysts

Ancestor Terms

ID	Term
D009369	Neoplasms
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided