Intra-articular hyaluronic acid for haemophilic ankle arthropathy
Research type
Research Study
Full title
A single centre, open label, pilot study evaluating the effect of intra-articular hyaluronic acid injection on pain and functionality when injected into the ankle (tibio-talar and sub-talar) joint in patients with haemophilic arthropathy.
IRAS ID
236372
Contact name
Nicola Curry
Contact email
Sponsor organisation
Oxford Univeristy Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 9 months, 30 days
Research summary
Haemophilia is the most common inherited severe bleeding disorder which puts patients at increased risk of bleeding into large joints, such as the ankle. Bleeding leads to changes within the joints, including joint lining inflammation (synovitis), and this in turn results in further bleeding and chronic synovitis. Blood in the joint can also directly damage the cartilage, and with repeated bleeding, there is progressive destruction of both cartilage and bone. The end result is known as haemophilic arthropathy. The most common joint affected with haemophilic arthropathy is the ankle complex. Both the tibiotalar and the subtalar joints may be affected within the ankle complex. Haemophilic arthropathy affects young men and this has a significant impact on their occupation, earning capacity and participation in normal family life.
Physiotherapy, pain-killers and steroid joint injections are all helpful for management of haemophilic arthropathy but there is a need for an intervention for the damaged osteoarthritic joint where surgery is not appropriate. Routine options for pain-killers for persons with haemophilia (PwH) are limited as standard non-steroidal anti-inflammatory drugs (NSAIDs) are contra-indictated. COX-2 inhibitor therapy has associations in certain patient groups with increased cardiovascular risk.
Ostenil Plus (Hyaluronic acid plus mannitol) has the potential to bridge the ‘treatment gap’ between simple analgesia and more complex orthopaedic solutions for haemophilic arthropathy. In particular in those patients with ‘bone-on-bone’ arthropathic changes, Ostenil Plus may provide cushioning to the damaged joint and in turn reduce pain and increase functionality of the joint. The potential benefits to patients may be great, and may also be more acceptable to patients when compared with an orthopaedic solution.
This pilot study will explore whether Ostenil Plus joint injection improves pain and functionality of the ankle joint in persons with haemophilia.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0422
Date of REC Opinion
24 Oct 2018
REC opinion
Further Information Favourable Opinion