Prevalence of Synovitis in Patients With Haemophilia A
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: Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS).
- Who it may be relevant to
- Registry conditions: Haemophilia A, Synovitis, Hemophilia Arthropathy, Sonography. Basic parameters: from 18 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
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prevalence of Synovitis in Adult Patients With Haemophilia A in Germany and Austria
Overview
The aim of this study is to evaluate the prevalence of synovitis in adult patients with haemophilia A.
Detailed description
The bleeding disorder haemophilia causes recurrent spontaneous bleedings primarily into the joints and soft tissues. The reason is a congenital lack of factor VIII (haemophilia A) or factor IX (haemophilia B). In Germany, the most affected joints are the ankle, knee, and elbow. The joint bleedings are accompanied by pain and an inflammatory process that leads to synovitis and ultimately to degenerative joint changes resulting in haemophilic arthropathy: The synovial tissue is responsible for removing blood residuals from the joint cavity. However, blood components, especially iron, induce several changes in the synovial tissue. The resulting synovitis leads to damage of cartilage, bone cysts, osteophytes, and joint effusions. Synovitis can even become a bleeding-independent process, especially after repeated bleeding. According to current knowledge, there is no option to prevent synovitis except for preventing bleedings.
In the aftermath of recurrent joint bleedings, various changes in the synovial tissue, the articular cartilage, and the subchondral bone and blood vessels are observed. These changes are accompanied by restricted joint mobility and musculoskeletal dysfunction. In addition to these peripheral structural changes, various studies show that the entire musculoskeletal system is also affected by recurrent joint bleedings, as it adapts to pain.
Improved therapy over the past decades has led to a reduction in major joint bleeding rates. For this reason, it is important to examine whether this has improved the average joint status and how often patients with haemophilia (PwH) are affected by synovitis at all. Sonography is the radiation-free method of choice for the initial determination of synovitis.
In addition to the structural consequences, joint bleedings also lead to pain and reduction in physical performance. When considering the overall process of degenerative joint changes of PwH, it becomes apparent that this also reduces daily mobility and muscle strength. To the best of our knowledge, the effects of the degree of synovitis on pain perception and physical performance have not been evaluated in previous studies.
For this reason, the prevalence of synovitis in PwH and the consequences in relation to the pain situation and physical performance will be investigated.
Interventions
- Diagnostic test Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US); Haemophilia joint health score (HJHS)
Each subject is examined for the presence of synovitis using the aforementioned diagnostics.
Primary outcome measures
- Haemophilia early arthropathy detection with ultrasound (HEAD-US) [Time frame: 20 minutes]
Secondary outcome measures (3)
- The Hemophilia Joint Health Score version 2.1 (HJHS) [Time frame: 45 minutes]
- PROMIS-29 Questionaire [Time frame: 10 minutes]
- Haemophilia Activities List (HAL) [Time frame: 10 minutes]
Eligibility criteria
Inclusion criteria
- Participants (≥ 18 years old) suffering from moderate or severe haemophilia A, also with inhibitor or joint replacement
- Complete documentation of hemophilia severity, treatment history (past 12 months), and bleeding events (past 12 months), inhibitor status (at time of enrollment and in past medical history)
- Submitted written consent to participate in the study
Exclusion criteria
- Patients suffering from other bleeding disorders conflicting with the research question
- Patients in clinical studies with investigational drugs
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
Germany · 1 center
- University Hospital Bonn — Bonn
Identifiers
NCT: NCT06352216 · Elo-Ger-2023-1642