Total Ankle Replacement Versus Arthrodesis Trial

A Randomised, Multi-centre, Non-blinded, Prospective, Parallel Group Trial of Total Ankle Replacement (TAR) Versus Ankle Arthrodesis in Patients With End Stage Ankle Osteoarthritis, Comparing Clinical Outcomes and Cost-effectiveness.

The purpose of TARVA is to determine whether Total Ankle Replacement (TAR) provides better clinical outcomes than ankle arthrodesis in patients aged 50-85 years with end-stage ankle osteoarthritis, and compare cost-effectiveness of the two treatments

This is a randomised, multi-centre, non-blinded, prospective, parallel-group trial of TAR versus ankle arthrodesis in patients with end-stage ankle osteoarthritis (OA) aged between 50 and 85 years, comparing clinical outcomes (pain-free function, quality of life (QoL), range of motion (ROM), and rate of post-procedural complications) and cost-effectiveness. TARVA is a clinician-led, pragmatic, superiority trial designed to compare the improvement in pain-free function, as assessed by the Manchester-Oxford Foot Questionnaire (MOXFQ) walking/standing domain score from pre-op to 52 weeks post-op for each surgical treatment group. A total of 328 patients will be randomly allocated on an equal basis to one of two surgical treatments: i) Total Ankle Replacement; and ii) Ankle Arthrodesis. Randomisation will be stratified by surgeon and presence of OA in two adjacent joints as determined by a pre-operative MRI scan.

Inclusion Criteria:

• Diagnosis of end-stage ankle osteoarthritis
• Aged 50-85 years inclusive
• The surgeon believes the patient is suitable for both TAR and arthrodesis (having considered deformity, stability, bone quality, soft tissue envelope, and neurovascular status)
• The patient is able to read and understand the Patient Information Sheet (PIS) and trial procedures
• The patient is willing and able to provide written informed consent

Exclusion Criteria:

• Previous ipsilateral talonavicular, subtalar or calcaneocuboid fusion or surgery planned within 1 year of index procedure
• More than 4 lower limb joints fused (including contralateral limb, but excluding proximal interphalangeal joint fusions)
• • Unable to have MRI/CT scan (e.g. severe claustrophobia or contraindication for either scan)
• History of local bone or joint infection
• Any co-morbidity, which, in the opinion of the investigator, is severe enough to; interfere with the patient's ability to complete the study assessments or; presents an unacceptable risk to the patient's safety
• Participant in another clinical trial that would materially impact on their participation in this study