Total Ankle Replacement Versus Ankle Arthrodesis (TARVA) trial: A pragmatic, randomised controlled trial to assess clinical and cost effectiveness, with an internal feasibility phase.
Surgeons across the NHS cannot agree on whether to replace or fuse a severely arthritic ankle, so this trial will randomly assign patients to one of the two operations and compare the results head-to-head. End-stage ankle osteoarthritis leaves people in constant pain and struggling to walk, yet there is no clear evidence to tell surgeons which of the two main surgical options—total ankle replacement or ankle fusion (arthrodesis)—works better or costs less. Current practice varies wildly from hospital to hospital, meaning patients get different treatments depending on where they live. This trial directly addresses that uncertainty by running a pragmatic comparison inside 12 NHS hospitals, using the implants and techniques surgeons already use. If the trial shows one treatment is clearly superior in terms of pain relief, mobility, or cost-effectiveness, it could end the national variation in practice and give surgeons a definitive answer. That would allow patients and clinicians to choose with confidence, reduce the number of people needing repeat surgery, and help the NHS allocate resources more efficiently. The primary outcome is measured by a validated patient-reported questionnaire, so the results will reflect what matters most to the people undergoing these operations.
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DESIGN: A multi-centre randomized pragmatic open trial of total ankle replacement (TAR) versus ankle arthrodesis with an internal feasibility phase in patients with end-stage ankle osteoarthritis (OA). Randomisation will use a minimisation algorithm incorporating a random element, stratifying by surgeon and presence of OA in the 2 joints adjacent to the ankle (subtalar and talonavicular) – as determined by a preoperative MRI scan. SETTING: 12 committed NHS hospitals including district general hospitals, University teaching hospitals and Specialist centres. TARGET POPULATION: Patients aged 50-85 with end-stage ankle OA not meeting the exclusion criteria. HEALTH TECHNOLOGIES BEING ASSESSED: TAR is being compared to ankle arthrodesis, the two main surgical treatments for end-stage Ankle OA. We aim to run a pragmatic trial comparing two existing NHS surgical treatment options. There is marked variation in practice nationally. To ensure treatment homogeneity for TAR we will only use third generation (mobile bearing) CE marked implants with an agreed post-operative protocol. Ankle arthrodesis will be by the surgeon’s usual technique, again with a similar post-operative protocol. Surgical trials that specify a single type of implant are notoriously difficult to conduct and we do not believe such a design could recruit surgeons, nor would the outputs be generalizable across the NHS. MEASUREMENT OF COSTS AND OUTCOMES: The primary outcome measure is the change in Manchester Oxford Foot & Ankle Questionnaire (MOXFQ) walking/standing domain scores from pre-op to 1 year post-op. MOXFQ is a validated clinical score, and the most published patient reported measure for foot and ankle conditions. A search of www.comet-initiative.org has not identified other established relevant Core Outcomes. Secondary outcome measures include MOXFQ pain and social interaction domains, EQ-5D, AOFAS score, revision surgery, other reoperation, complications, and resource utilisation. The incremental cost and cost-effectiveness of both treatments from the NHS and societal perspectives will be compared in terms of quality-adjusted life years, based on the EQ-5D. Resource use will be collected directly from patient notes and patient diaries. INCLUSION CRITERIA: Patients with end-stage ankle OA; age 50-85 inclusive; fit for an anaesthetic; no exclusion criteria. EXCLUSION CRITERIA: Deformity greater than 25 degrees at Tibiotalar joint (on standing films); Complete ligamentous disruption and clinical instability; poorly controlled diabetes (HbA1C level of over 9% or as advised by the diabetologist); moderate to severe avascular necrosis of the talus (more than 15% talus affected on plain x- ray); history of infection in ipsilateral ankle/foot; more than 3 lower limb joints previously fused (ipsilateral) and/or more than 4 bilateral; patient has had concomitant ipsilateral subtalar or talonavicular fusion or where this is planned; poor vascular supply (established critical limb ischaemia or active leg ulceration); serious concomitant disease (metastatic disease or terminal illness); severe osteoporosis (T Score of less than -2.5) with recent fracture (within last 12 months); pregnancy; unable to give informed consent – cognitive impairment demonstrated by Mini-Mental State Exam (MMSE) of under 16/30; patient unwilling to give informed consent. SAMPLE SIZE: To detect a difference of 12 (the minimum clinically important detectable change) in the post-operative change in MOXFQ walking/standing domain score (primary outcome) between the two treatment groups assuming a standard deviation of 27, a significance level of 5%, and power of 90%, a sample size of 214 participants is required. To account for clustering by surgeon, assuming an average cluster size of 14 (participants/surgeon) and an Intra-class correlation coefficient (ICC) of 0.03 (estimated from the median of 10 previous surgical studies) an adjusted sample size of 298 is required. After
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