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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00212485

Enrollment

Registered

2005-09-21

Start date

2005-09-30

Completion date

2009-05-31

Last updated

2010-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inherited Bleeding Disorders

Keywords

Hemophilia, Factor Deficiency, synovitis, sonogram

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.

Interventions

PROCEDUREPower Doppler Sonography

Power Doppler with gray-scale sonography is used to detect and quantify alterations in vascularity inside knee, elbow and ankle joints.

PROCEDUREMRI

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Comparison of magnetic resonance imaging (MRI) and power Doppler sonograms on patients with target joint	Up to 1 month
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.
Evaluation of PDS on patients with at least 2 joint bleeds to diagnose early synovitis	1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026