Joint distraction in the treatment of haemophilic ankle arthropathy: clinical and structural efficacy, a pilot study

Joint distraction in the treatment of haemophilic ankle arthropathy: clinical and structural efficacy, a pilot study - Joint distraction in haemophilic ankle arthropathy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46992

Enrollment

Registered

2013-03-28

Start date

2013-08-26

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bleeding disorder haemophilia

Interventions

All ten patients included will be treated by ankle joint distraction during ten weeks. An external frame will generate 5 mm distraction of the joint.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Change from baseline to 1 year after distraction in the ankle osteoarthritis scale, a validated questionnaire in degenerative ankle complaints.	—

Secondary

Measure	Time frame
A) Other clinical parameters - change in functionality measured by questionnaires and functional tests B) Tissue (bone, cartilage, and soft tissue) structure changes will be measured by imaging (X-ray and MRI), and analysis of biochemical markers of cartilage and bone turnover. C) Short-term costs (during surgery patients need high levels of expensive clotting factor) is assessed by questionnaires on employment and medical usage, and registration of clotting factor consumption. D) Quality of life, measured by the EQ-5D questionnaire, also during treatment to assess the psychological burden of the treatment	—

Measure

Time frame

A) Other clinical parameters - change in functionality measured by questionnaires and functional tests B) Tissue (bone, cartilage, and soft tissue) structure changes will be measured by imaging (X-ray and MRI), and analysis of biochemical markers of cartilage and bone turnover. C) Short-term costs (during surgery patients need high levels of expensive clotting factor) is assessed by questionnaires on employment and medical usage, and registration of clotting factor consumption. D) Quality of life, measured by the EQ-5D questionnaire, also during treatment to assess the psychological burden of the treatment

—

Countries

Netherlands

Contacts

Public ContactL.F.D. Vulpen

Universitair Medisch Centrum Utrecht

l.f.d.vanvulpen-2@umcutrecht.nl0887558450

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)