Zygapophyseal Synovial Joint CystPhase 2NCT00837070
Percutaneous Rupture of Zygapophyseal Joint Cysts
A Phase 2 study testing Percutaneous zygapophyseal cyst rupture in people with Zygapophyseal Synovial Joint Cyst, run by Ullevaal University Hospital at 1 site in Norway.
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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Zygapophyseal Synovial Joint Cyst
- What is being tested?
- Percutaneous zygapophyseal cyst rupture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2009to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI.
Who cannot join
- Infection, uncontrollable bleeding disorder
Trial locations and contacts
1 site in 1 country.
Norway1 site
Departement of Neuroradiology Oslo university hospital avd Ullevaal
Oslo, 0407
About this study
Lumbar zygapophyseal joint cysts can cause lower extremity radiculopathy. These cysts can be cured by a minimally invasive technique: percutaneous cyst distention and rupture
Read the 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.
- Conditions
- Zygapophyseal Synovial Joint Cyst
- Being tested
- Percutaneous zygapophyseal cyst rupture
- Keywords
- Zygapophyseal, joint, cyst, Fluoroscopy, guided, percutaneous, Lumbar
- Medical subject headings
- Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous zygapophyseal cyst ruptureProcedure or surgery
Also called Axiom Artis Siemens
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Percutaneous zygapophyseal cyst rupture Receives: Procedure: Percutaneous zygapophyseal cyst rupture |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS(Visual analogue scale)for extremity pain
Measured: 1-3 and 12 months after intervention
Secondary outcomes (2)
Roland-Morris disability index
Measured: 1-3 and 12 months after intervention
Reduction of cyst size based om T2 MRI
Measured: 3 and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zygapophyseal Synovial Joint CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Therese Seierstad, Oslo University Hospital
- Investigators
- Øivind Gjertsen, Md, Msc, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837070
- Sponsor's protocol ID
- 264-07111a 2007.345
- Status last verified
- Sep 2017
- First submitted
- 4 Feb 2009
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Rupture of Zygapophyseal Joint Cysts
- ClinicalTrials.gov ID
- NCT00837070
- Acronym / sponsor ID
- 264-07111a 2007.345
- Conditions
- Zygapophyseal Synovial Joint Cyst
- Keywords
- Zygapophyseal, joint, cyst, Fluoroscopy, guided, percutaneous, Lumbar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Percutaneous zygapophyseal cyst rupturePercutaneous zygapophyseal cyst rupture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with lumbar zygapophyseal joint cyst and compression of a spinal nerve root with lower extremity radiculopathy proven by MRI.
Key exclusion criteria (1 listed)
- Infection, uncontrollable bleeding disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous zygapophyseal cyst ruptureAlso: Axiom Artis SiemensPatients 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. | Procedure or surgery | 1 |
Primary outcome
VAS(Visual analogue scale)for extremity pain
Time frame: 1-3 and 12 months after intervention
2 secondary outcomes
Roland-Morris disability index
Time frame: 1-3 and 12 months after intervention
Reduction of cyst size based om T2 MRI
Time frame: 3 and 12 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øivind Gjertsen, Md, Msc principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Percutaneous zygapophyseal cyst rupture in people with Zygapophyseal Synovial Joint Cyst, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS(Visual analogue scale)for extremity pain (time frame: 1-3 and 12 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017.