Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
Not Applicable
Completed
- Conditions
- Inherited Bleeding Disorders
- Registration Number
- NCT00212485
- Lead Sponsor
- New York Presbyterian Hospital
- Brief Summary
The purpose of this study is to see whether power Doppler sonography (PDS) can be used to diagnose synovitis in patients with inherited bleeding disorders.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
- Diagnosis of inherited bleeding disorder
For Aim 1:
- Age of at least 6 years
- History of at least 4 bleeds in the same joint in the preceding 6 months
- Joint swelling, synovitis or deformity
For Aim 2:
- Meet inclusion criteria for Aim 1 and will be having a synovectomy
For Aim 3:
- Age of at least 1 year
- Have had at least 2 joint bleeds
Exclusion Criteria
- Not meeting inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention 1. day of synovectomy; 2. 6 months post synovectomy. Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis 1 day Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint Up to 1 month
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York Presbyterian Hospital/Hospital for Special Surgery
🇺🇸New York, New York, United States