Joint distraction in the treatment of haemophilic ankle arthropathy: clinical and structural efficacy, a pilot study
- Conditions
- bleeding disorderhaemophilia1008362410023213
- Registration Number
- NL-OMON46992
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Patients with haemophilia A or B and severe complaints of ankle arthropathy in the upper ankle (talocrural) joint, insufficiently responding to analgetics and conservative treatment, and leading to functional limitations
Age >= 18 years and <= 55 years
Contra-indications for surgery in general according to standard clinical practice protocol.
Complaints of the ankle due to arthropathy primarily in the lower ankle joint .
Psychological inabilities making it impossible to wear a distraction frame for 10 weeks or difficulty to instruct.
Contra-indications for MRI examination according to standard clinical practice protocol.
Bone-to-bone contact in the joint (absence of any joint space on X-ray)
Inflammatory or rheumatoid arthritis in the affected ankle present or in history
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline to 1 year after distraction in the ankle osteoarthritis<br /><br>scale, a validated questionnaire in degenerative ankle complaints.</p><br>
- Secondary Outcome Measures
Name Time Method <p>A) Other clinical parameters - change in functionality measured by<br /><br>questionnaires and functional tests<br /><br>B) Tissue (bone, cartilage, and soft tissue) structure changes will be measured<br /><br>by imaging (X-ray and MRI), and analysis of biochemical markers of cartilage<br /><br>and bone turnover.<br /><br>C) Short-term costs (during surgery patients need high levels of expensive<br /><br>clotting factor) is assessed by questionnaires on employment and medical usage,<br /><br>and registration of clotting factor consumption.<br /><br>D) Quality of life, measured by the EQ-5D questionnaire, also during treatment<br /><br>to assess the psychological burden of the treatment</p><br>