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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

May 22, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

-Comparison of 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

Change History

Complete list of historical versions of study NCT00212485 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Inherited Bleeding Disorders

Intervention ^ICMJE

Procedure: Power Doppler Sonography
Procedure: MRI

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

September 2009

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Year to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00212485

Responsible Party

Suchitra Acharya, MD, New York Presbyterian Hospital

Study ID Numbers ^ICMJE

PDS

Study Sponsor ^ICMJE

New York Presbyterian Hospital

Collaborators ^ICMJE

Bayer

Investigators ^ICMJE

Principal Investigator:

Suchitra S Acharya, MD

Weill Medical College of Cornell University

Information Provided By

New York Presbyterian Hospital

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP