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

June 30, 2010 updated by: New York Presbyterian Hospital

Evaluation of the Role of Power Doppler Sonography 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.

Study Overview

Status

Completed

Conditions

Inherited Bleeding Disorders

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- New York
  - New York, New York, United States, 10021
    - New York Presbyterian Hospital/Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 60 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint Time Frame: Up to 1 month	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.	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	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York Presbyterian Hospital

Collaborators

Bayer

Investigators

Principal Investigator: Suchitra S Acharya, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria