Joint AbnormalitiesNCT00724659
Pre and Post Arthrogram Ultrasound Images of Joints
A study testing Ultrasound in people with Joint Abnormalities, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Abnormalities
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically ordered arthrogram
Who cannot join
- pregnant women
- children under the age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: An Evaluation of Pre and Post Arthrogram Ultrasound Images of Joints: Does Arthrography Have a Role in Ultrasonography?
The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints.
Read the detailed description
To determine if using intra-articular contrast (contrast injected into a joint) will provide clearer, more precise ultrasound images of the joints then an ultrasound done without the use of a contrast agent.
- Conditions
- Joint Abnormalities
- Being tested
- Ultrasound
- Keywords
- Arthrogram, Contrast, Joint, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)
UltrasoundProcedure or surgery
Ultrasound of the joint(s) after a clinically scheduled arthrogram is performed. Ultrasound images will then be compared to the arthrogram findings, other imaging findings such as MRI and surgical pathological findings such as arthroscopy (if any.)
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Pre-Arthrogram | Experimental | Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s) Receives: Procedure: Ultrasound |
| Ultrasound Post-Arthrogram | Experimental | Ultrasound of the joint(s) after the clinically scheduled arthrogram of the same joint(s), performed while the body still has a contrast agent in it from the arthrogram. The contrast agent varies with different joint areas, but is usually iodine based (like Ultravist.) Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startSep 2004
- Primary completionAug 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint AbnormalitiesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Jacobson, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724659
- Sponsor's protocol ID
- 2004-0761
- Status last verified
- May 2012
- First submitted
- 28 Jul 2008
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Pre and Post Arthrogram Ultrasound Images of Joints: Does Arthrography Have a Role in Ultrasonography?
- ClinicalTrials.gov ID
- NCT00724659
- Acronym / sponsor ID
- 2004-0761
- Conditions
- Joint Abnormalities
- Keywords
- Arthrogram, Contrast, Joint, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Aug 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jul 2008 (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.
The purpose of this study is to determine the usefulness of contrast in ultrasonography of the joints.
Detailed description
To determine if using intra-articular contrast (contrast injected into a joint) will provide clearer, more precise ultrasound images of the joints then an ultrasound done without the use of a contrast agent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Pre-Arthrogram | Experimental | Procedure: UltrasoundUltrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s) |
| Ultrasound Post-Arthrogram | Experimental | Procedure: UltrasoundUltrasound of the joint(s) after the clinically scheduled arthrogram of the same joint(s), performed while the body still has a contrast agent in it from the arthrogram. The contrast agent varies with different joint areas, but is usually iodine based (like Ultravist.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinically ordered arthrogram
Key exclusion criteria (2 listed)
- pregnant women
- children under the age of 18
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 |
|---|---|---|
| UltrasoundUltrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s) | Procedure or surgery | Ultrasound Pre-Arthrogram |
| UltrasoundUltrasound of the joint(s) after a clinically scheduled arthrogram is performed. Ultrasound images will then be compared to the arthrogram findings, other imaging findings such as MRI and surgical pathological findings such as arthroscopy (if any.) | Procedure or surgery | Ultrasound Post-Arthrogram |
Primary outcome
To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities.
Time frame: 1 year
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 3 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Joint Abnormalities, run by University of Michigan at 1 site in United States.
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 2 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 3 May 2012. 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 United States. 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.
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?
To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities. (time frame: 1 year). 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 3 May 2012.