Osteoarthritis of Acromioclavicular JointNCT01628796
Ultrasound Examination and Guided Injection Into the Acromio-clavicular Joint
A study testing contrast material injection in people with Osteoarthritis of Acromioclavicular Joint, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Acromioclavicular Joint
- What is being tested?
- contrast material injection
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults over 18 years with AC joint degenerative changes
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Measurement of the Acromio-clavicular Joint and Injection of Standard Contrast Material Into the Joint Under Ultrasonic Control
Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?
- Being tested
- contrast material injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast material injectionOther
Also called iomeron 350
using ultrasound to locate ac joint and injecting contrast material to ensure that the dye is actually in the joint
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray
standard x-ray will be taken after the contrast dye has been injected into the joint to see whether it has successfully been placed into the joint.
Measured: outcome assessed at the time of the injection (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of Acromioclavicular JointStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, gordon edelson, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628796
- Sponsor's protocol ID
- 08-2012.CTIL
- Status last verified
- Jun 2012
- First submitted
- 19 Jun 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurement of the Acromio-clavicular Joint and Injection of Standard Contrast Material Into the Joint Under Ultrasonic Control
- ClinicalTrials.gov ID
- NCT01628796
- Acronym / sponsor ID
- 08-2012.CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 27 Jun 2012 (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.
Is it possible to improve the accuracy of injection into the acromio-clavicular joint with the use of ultrasound?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults over 18 years with AC joint degenerative changes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| contrast material injectionAlso: iomeron 350using ultrasound to locate ac joint and injecting contrast material to ensure that the dye is actually in the joint | Other | – |
Primary outcome
ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray
Time frame: outcome assessed at the time of the injection (1 day)
standard x-ray will be taken after the contrast dye has been injected into the joint to see whether it has successfully been placed into the joint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2012.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing contrast material injection in people with Osteoarthritis of Acromioclavicular Joint, run by The Baruch Padeh Medical Center, Poriya.
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 0 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: status not confirmed, as of the sponsor's last update on 27 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gordon Edelson, MD (97246652670, edelson@bezeqint.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound controlled injection of contrast material into the AC joint followed by standard x-ray (time frame: outcome assessed at the time of the injection (1 day)). 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 27 Jun 2012.