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Completed

NCT Number: NCT00212485

Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease

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.

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Key information

Conditions

Inherited Bleeding Disorders Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders Joint Diseases Musculoskeletal Diseases Synovitis

Age range

1 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital/Hospital for Special Surgery

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Power Doppler Sonography

Procedure

Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.

MRI

Procedure

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.

Primary outcomes

  1. Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint

    Time frame: Up to 1 month

  2. 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.

  3. Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

New York Presbyterian Hospital

Other

Collaborators

  • Bayer

Registry information

Official study title

Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Sep 21, 2005
Registry last updated
Jul 1, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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