search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


De waarde van echo en MRI bij de evaluatie van gewrichtsschade bij hemofilie


- candidate number19338
- NTR NumberNTR4754
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-aug-2014
- Secondary IDsMETC 14-274 University Medical Center Utrecht
- Public TitleDe waarde van echo en MRI bij de evaluatie van gewrichtsschade bij hemofilie
- Scientific TitleThe value of ultrasound compared to magnetic resonance imaging in haemophilic arthropathy
- ACRONYM
- hypothesis- The diagnostic accuracy of ultrasound assessment regarding the synovium in patients with haemophilia is > 70%.
- Soft tissue changes on initial MRI are associated with osteochondral changes on re-examination after 5 years, independent of bleeding-history in patients with haemophilia.
- Haemosiderin on MRI could be cleared five years later in joints of haemophilic patients without new joint bleeds
- Healt Condition(s) or Problem(s) studiedHaemophilia, Arthropathy , Ultrasonography, MRI
- Inclusion criteria* Aged 18-32 year
* Clinical and radiological absent or minimal arthropathy
* Severe (<1% FVIII/IX activity) or moderate haemophilia (1-5% FVIII/IX activity)
(* MRI assessment of both knees and ankles by the standardized MRI protocol in 2009/2010)
- Exclusion criteria* History of inhibitors
* Contra indication for MRI
* Exclusion of joints in case of a severe joint injury, joint surgery, or development of a target joint since initial MRI assessment in 2009/2010
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2014
- planned closingdate1-feb-2016
- Target number of participants24
- InterventionsDiagnostic procedures:
* Ultrasound assessment of knees and ankles
* MRI assessment of knees and ankles
- Primary outcomeDiagnostic accuracy of ultrasound assessment of the synovium in haemophilic arthropathy compared to MRI
- Secondary outcome* Association of soft tissue changes on initial MRI with osteochondral changes on re-examination after 5 years
* Reversibility of intra-articular haemosiderin
- Timepoints-
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES W. Foppen
- CONTACT for SCIENTIFIC QUERIES W. Foppen
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Baxter
- Publications
- Brief summaryRepeated provoked or spontaneous bleeding into the joints are the hallmark of haemophilia. From a clinical perspective, it is important to assess early, potentially reversible, joint changes in patients with normal findings on physical examination and X-rays. Consequently there is an increasing interest in the use of Magnetic Resonance Imaging (MRI) and ultrasound. So far, there is no literature available about the diagnostic accuracy of a recently developed, simple and fast, ultrasound protocol. Besides, the clinical relevance of early changes detected by MRI and ultrasound is still unclear. It is not known if subtle alterations such as haemosiderin and synovial hypertrophy seen on MRI are reversible or not, and if they have a predictive value for development of osteochondral changes. The primary objective of this study is to establish the diagnostic accuracy of ultrasound assessment of the synovium in haemophilic arthropathy compared to MRI. Secondary objectives are to determine whether or not synovial hypertrophy on MRI is able to predict osteochondral changes on MRI five years later and to evaluate if intra-articular haemosiderin can be cleared in five years.
- Main changes (audit trail)
- RECORD21-aug-2014 - 11-nov-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl