Haemophilic arthropathy of the ankle Musculoskeletal Diseases
Conditions
Interventions
This study is a pilot, single centre study that will address the question: does intra-articular Ostenil Plus improve pain and functionality in participants with haemophilic arthropathy of the ankle co
Sponsors
Oxford University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained before any study related activity 2. Adult male (age 18 years or older) with haemophilia A or haemophilia B of any severity, including those with inhibitors 3. MRI ankle changes consistent with haemophilic arthropathy – showing synovitic and/or degenerative changes to one or both ankle joints
Exclusion criteria
Exclusion criteria: 1. The patient has evidence of infection, including those patients taking antibiotic therapy 2. The patient has known inflammatory joint disease, including crystal disease 3. The patient has received an intra-articular steroid injection within the preceding 6 months 4. The patient is known to be allergic to any of the excipients of Ostenil Plus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured by the VAS pain score; Timepoint(s): 3, 6, 9, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functionality of the haemophilia ankle measured by the ankle HJHS score, the foot and ankle mobility measure (FAAM) and the global HJHS score at 3, 6, 9, 12 months 2. Quality of life measured by the EQ-5D-5L and Haemophilia Activity List (HAL) at 3, 6, 9, 12 months 3. Safety of treatment, including increased pain and stiffness to the injected joint at 3, 6, 9, 12 months | — |
Countries
England, United Kingdom
Outcome results
None listed