Back to resultsPre and Post Arthrogram Ultrasound Images of Joints
Primary Purpose
Joint Abnormalities
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Joint Abnormalities focused on measuring Arthrogram, Contrast, Joint, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- clinically ordered arthrogram
Exclusion Criteria:
- pregnant women
- children under the age of 18
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ultrasound Pre-Arthrogram
Ultrasound Post-Arthrogram
Arm Description
Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)
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.)
Outcomes
Primary Outcome Measures
To add to the general knowledge of the researchers and to possibly benefit future patients in the diagnosis and treatment of joint abnormalities.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00724659
Brief Title
Pre and Post Arthrogram Ultrasound Images of Joints
Official Title
An Evaluation of Pre and Post Arthrogram Ultrasound Images of Joints: Does Arthrography Have a Role in Ultrasonography?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Abnormalities
Keywords
Arthrogram, Contrast, Joint, Ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound Pre-Arthrogram
Arm Type
Experimental
Arm Description
Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)
Arm Title
Ultrasound Post-Arthrogram
Arm Type
Experimental
Arm Description
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.)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound of the joint(s) before the clinically scheduled arthrogram of the same joint(s)
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
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.)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinically ordered arthrogram
Exclusion Criteria:
pregnant women
children under the age of 18
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pre and Post Arthrogram Ultrasound Images of Joints
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