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

Inherited Bleeding Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212485
• Other study ID #: PDS
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: June 30, 2010
• Start date: September 2005
• Est. completion date: May 2009

Study information

• Verified date: June 2010
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 60 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders
• Inherited Bleeding Disorders
• Joint Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Presbyterian Hospital	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint		Up to 1 month	No
Primary	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.	No
Primary	Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis		1 day	No