No registrations found.
ID
Source
Health condition
haemophilia, arthropathy, joint damage
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic 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
Background summary
Repeated 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.
Study objective
- 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
Study design
-
Intervention
Diagnostic procedures:
* Ultrasound assessment of knees and ankles
* MRI assessment of knees and ankles
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4603 |
NTR-old | NTR4754 |
Other | University Medical Center Utrecht : METC 14-274 |