Patients with ankle arthritis required for clinical trial comparing the two main surgical treatments

We are recruiting patients aged 50-85 years with severe ankle arthritis who are considering having surgery, for a trial comparing the two most common surgical treatments: total ankle replacement, and ankle arthrodesis (fusion).

Patients are eligible for the trial if their surgeon considers them suitable for either procedure, and they are willing to have their surgical treatment assigned randomly (i.e. there is an equal chance of being allocated either type of surgery).

If you wish to participate you will need your GP to refer you to a Consultant Orthopaedic Surgeon at a participating hospital (see anklearthritis.co.uk for details), where you will have a Magnetic Resonance Imaging (MRI) scan of your affected ankle. After the scan, you will be randomly allocated to have either ankle replacement or ankle arthrodesis (fusion) surgery. After your operation you be asked to attend follow-up visits at the hospital at 2, 6, 12, 26 and 52 weeks. You will also be asked to complete questionnaires about your health and wellbeing, and any other treatments you are on or clinics you are attending, before and after your operation. Researchers will use this information to help determine which treatment gives the best outcomes for patients one year after surgery.

You can find out more about the treatments, as well as details of your closest participating NHS hospital on our website at anklearthritis.co.uk or contact us with any queries at tarva@rnoh.nhs.uk. You can also follow us on Twitter @Tarva_Trial.

Date required

Ongoing

Organisation

Comprehensive Clinical Trials Unit at UCL

Contact

tarva@rnoh.nhs.uk

anklearthritis.co.uk

Clinical Trial Registration Details

ISRCTN60672307
isrctn.com/ISRCTN60672307

ClinicalTrials.gov Identifier: NCT02128555 clinicaltrials.gov/ct2/show/NCT02128555