Synovial Proliferation on Routine Ultrasound: Active or Inactive?
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound imaging.
- Who it may be relevant to
- Registry conditions: Haemophilia, Hemophilia A, Hemophilia B. Basic parameters: from 12 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Synovial Proliferation on Routine Ultrasound: Active or Inactive? A Prospective Study
Overview
There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. Patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, MRI, ultrasound and elastography. Synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the NSAID celecoxib (optional).
Detailed description
To be completed
Interventions
- Other Ultrasound imaging
Ultrasound, MRI and elastography to screen for and follow subclinical synovial changes in ankle, elbow and knee.
Primary outcome measures
- - The primary objective of this study is to evaluate the diagnostic accuracy of physical examination and ultrasound to identify active synovial proliferation in haemophilia patients with subclinical synovial hypertrophy. [Time frame: 12 weeks]
Secondary outcome measures (3)
- - To identify predictors for (changes in) synovial proliferation status within participant characteristics (age, baseline treatment, joint bleeding history) and joint characteristics (extent of arthropathy (Pettersson score on X-rays)). [Time frame: 12 weeks]
- - To evaluate the diagnostic accuracy of the presence of synovial hemosiderin, as measured by MRI, to identify active synovial proliferation in haemophilia patients with subclinical synovial hypertrophy. [Time frame: 12 weeks]
- - To evaluate the diagnostic accuracy of synovial elastography to identify active synovial proliferation in hemophilia patients with subclinical synovial hypertrophy [Time frame: 12 weeks]
Eligibility criteria
Inclusion criteria
- Gender: male
- Patients with severe haemophilia A or B
- Treated with registered prophylaxis medication including coagulation factors and by- passing agents.
- Age ≥ 12 years
- Subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score >0 according to the HEAD-US protocol, as confirmed during routine ultrasound screening.
- Able to give written informed consent.
Exclusion criteria
- A major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest.
- On demand therapy.
- Currently treated with any type of haemophilia prophylaxis medication.
- Joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. However, participants may still be included in the study with their other joints.
- Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis.
- History of inhibitor development (≥ 5 Bethesda Units\* (BU) at any time or 1-5 BU for
- 1 year prior to inclusion.
- Contra-indication for treatment with NSAIDs, (allergy, severe liver failure, renal failure (GFR <30ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease and/or cerebrovascular disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Utrecht — Utrecht
Identifiers
NCT: NCT06809972 · 2BEGIN