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 (2A) to determine whether or not synovial hypertrophy on MRI is…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Research question 1: Ultrasound and MRI scores for synovial hypertrophy
according to the HEAD-US score and the additive IPSG MRI score respectively.
Secondary outcome
Research question 2a: MRI scores for synovial hypertrophy, haemosiderin, and
osteochondral defects on the initial MRI, and MRI scores for osteochondral
defects at re-examination.
Research question 2b: MRI scores for synovial hypertrophy at the initial MRI,
and MRI scores for synovial hypertrophy at re-examination.
Determinants of interest are: Number of joint bleeds between MRI examinations
specified per joint, age, history of joint injuries, and Body Mass Index (BMI).
Background summary
Repeated provoked or spontaneous bleeding into the joints are the hallmark of
haemophilia. Recurrent or prolonged joint bleeds eventually lead to synovial
hypertrophy, progressive cartilage degradation and bone damage through
mechanical and metabolic joint destruction. Joint assessment in haemophilia is
important to assess results of the expensive replacement therapy with clotting
factor concentrates. Traditionally, the six main joints (elbows, knees, and
ankles) were examined with standard X-rays. However, standard X-rays are able
to assess osteochondral changes only, and therefore detect late and mostly
irreversible joint changes. From a clinical perspective, it is important to
assess early, potentially reversible, joint changes in patients with normal
findings on physical examination and X-ray. Consequently there is an increasing
interest in the use of Magnetic Resonance Imaging (MRI) and ultrasound. MRI is
the most sensitive imaging modality to demonstrate effusion or haemartrosis,
synovitis, and cartilage defects. However, MRI assessment is less available
than a standard X-ray, it is expensive and time consuming. Therefore MRI is not
the first choice for routine joint assessment in the absence of major
complaints. The typical haemophilic joint changes including effusion or
haemartrosis, synovitis, and cartilage defects can be assessed by ultrasound
too and show strong correlations with MRI findings. Unfortunately the operator
dependency of ultrasound is a potential disadvantage, and previous ultrasound
protocols for haemophilic arthopathy were too time consuming to use in daily
practice. For both imaging modalities new scoring systems have been published
recently to evaluate haemophilic arthropathy: the MRI scale by the
International Prophylaxis Study Group (IPSG) and a simplified ultrasound
scanning procedure (Haemophilia Early Arthropathy Detection with Ultrasound
(HEAD-US)). So far, there is no literature available about the accuracy of the
HEAD-US score compared to MRI. 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.
Study objective
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 (2A) to determine whether or not synovial
hypertrophy on MRI is able to predict osteochondral changes on MRI five years
later and (2B) to evaluate if intra-articular haemosiderin be cleared in five
years.
Study design
Cross-sectional study for the primary objective on the value of ultrasound in
patients with haemophilia. Longitudinal observational study for the secondary
objectives using clinical follow-up and baseline data of a previous MRI study
(METC 07-220).
Study burden and risks
Participating patients will spent more time in the hospital at the day of their
planned clinical follow-up due to the additional US and MRI examination.
Patients will not have a direct benefit from participating in this study: their
bleeding pattern and current outcome will not change. On long term, patients
are expected to benefit from the optimization of treatment due to detailed
assessment of outcome.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
• Clinical and radiological absent or minimal arthropathy
• Participation in MRI study by Den Uijl:
- MRI assessment of both knees and ankles by the standardized MRI protocol described by Den Uijl in 2009/2010
- Severe (<1% FVIII/IX activity) or moderate haemophilia (1-5% FVIII/IX activity)
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 |
---|---|
CCMO | NL49256.041.14 |