Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352216
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-07
Brief Title:
Prevalence of Synovitis in Patients With Haemophilia A
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Prevalence of Synovitis in Adult Patients With Haemophilia A in Germany and Austria
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SynoPrev
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None