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

Primary Purpose

Inherited Bleeding Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Power Doppler Sonography
MRI
Sponsored by
New York Presbyterian Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inherited Bleeding Disorders focused on measuring Hemophilia, Factor Deficiency, synovitis, sonogram

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital/Hospital for Special Surgery

Outcomes

Primary Outcome Measures

Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint
Evaluation of PDS on patients with target joints pre and post synovectomy to assess response to therapeutic intervention
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
June 30, 2010
Sponsor
New York Presbyterian Hospital
Collaborators
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00212485
Brief Title
Study to Evaluate the Use of Ultrasound in the Diagnosis of Hemophilic Joint Disease
Official Title
Evaluation of the Role of Power Doppler Sonography in the Diagnosis of Hemophilic Joint Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
New York Presbyterian Hospital
Collaborators
Bayer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inherited Bleeding Disorders
Keywords
Hemophilia, Factor Deficiency, synovitis, sonogram

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Power Doppler Sonography
Intervention Description
Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
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 Outcome Measure Information:
Title
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint
Time Frame
Up to 1 month
Title
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.
Title
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suchitra S Acharya, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital/Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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