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

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by:
New York Presbyterian Hospital
ClinicalTrials.gov Identifier:
NCT00212485
First received: September 13, 2005
Last updated: June 30, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Inherited Bleeding Disorders
Procedure: Power Doppler Sonography
Procedure: MRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease

Resource links provided by NLM:


Further study details as provided by New York Presbyterian Hospital:

Primary Outcome Measures:
  • Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint [ Time Frame: Up to 1 month ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   1 Year to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00212485

Locations
United States, New York
New York Presbyterian Hospital/Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
New York Presbyterian Hospital
Bayer
Investigators
Principal Investigator: Suchitra S Acharya, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Suchitra Acharya, MD, New York Presbyterian Hospital
ClinicalTrials.gov Identifier: NCT00212485     History of Changes
Other Study ID Numbers: PDS
Study First Received: September 13, 2005
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by New York Presbyterian Hospital:
Hemophilia
Factor Deficiency
synovitis
sonogram

Additional relevant MeSH terms:
Joint Diseases
Blood Coagulation Disorders
Hemostatic Disorders
Musculoskeletal Diseases
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 22, 2014