Intra-articular hyaluronic acid for haemophilic ankle arthropathy

Not Applicable

Completed

• Conditions: Haemophilic arthropathy of the ankle; Musculoskeletal Diseases

• Registration Number: ISRCTN19698897
• Lead Sponsor: Oxford University Hospitals NHS Foundation Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35905300/ (added 01/08/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-04
• Study Completion: 2020-08-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measured by the VAS pain score; Timepoint(s): 3, 6, 9, 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Quality of life measured by the EQ-5D-5L and Haemophilia Activity List (HAL) at 3, 6, 9, 12 months<br> 3. Safety of treatment, including increased pain and stiffness to the injected joint at 3, 6, 9, 12 months<br>