Total Ankle Replacement Versus Arthrodesis Trial (TARVA)

University College London (UCL)

Status

Active, not recruiting

Conditions

Osteoarthritis

Treatments

Procedure: Total Ankle Replacement

Procedure: Arthrodesis

Study type

Interventional

Funder types

Other

Identifiers

NCT02128555

U1111-1157-4155 (Registry Identifier)

12/0518

12/35/27 (Other Grant/Funding Number)

ISRCTN60672307 (Registry Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment

303 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

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