Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
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|ClinicalTrials.gov Identifier: NCT00212485|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : July 1, 2010
|Condition or disease||Intervention/treatment||Phase|
|Inherited Bleeding Disorders||Procedure: Power Doppler Sonography Procedure: MRI||Not Applicable|
Aim #1 - To determine if PDS can be used to diagnose synovial hypertrophy and inflammation in joint disease associated with inherited bleeding disorders. MRI will be used as a reference standard.
Aim #2 - To determine if PDS can be used to assess therapeutic response to treatment.
Aim #3 - To determine if PDS can be used as a screening tool for diagnosing early synovitis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||May 2009|
- Procedure: Power Doppler Sonography
Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.
- Procedure: MRI
Magnetic Resonance Imaging with intravenous gadolinium contrast will be done using a standardized protocol, including a spin echo T2 weighted image and gradient echo images.
- Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint [ Time Frame: Up to 1 month ]
- Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention [ Time Frame: 1. day of synovectomy; 2. 6 months post synovectomy. ]
- Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212485
|United States, New York|
|New York Presbyterian Hospital/Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Suchitra S Acharya, MD||Weill Medical College of Cornell University|