Award winning study for the treatment of ankle arthritis
However, when it comes to choosing between these procedures, there’s a notable lack of information available to patients and surgeons alike. Consultant orthopaedic surgeon with HCA Healthcare UK, Andrew Goldberg, explains:
“Fortunately, most patients with ankle arthritis respond well to non-operative treatments, but once these have been tried and failed, and surgery is being considered, it is a really difficult choice for our patients to decide which treatment is best because the two treatments are so very different”.
He continues, “In an ankle fusion, the joint is stiffened so there’s no motion, while in a total ankle replacement the joint retains motion, and although both treatments have been shown to be effective at treating pain and improving function, there is very little scientific evidence as to which treatment is best.”
First steps, funding and feasibility
It was a desire to bridge this knowledge gap that led Mr Goldberg and a dedicated team of more than 50 clinical experts, based across 17 NHS Trusts, to come up with TARVA (Total Ankle Replacement Versus Arthrodesis) – a randomised clinical trial, it’s designed to provide a direct comparison between the two surgical treatments, giving end-stage ankle arthritis patients a meaningful choice.
There have been attempts at randomised controlled trials before, but each fell at the first hurdle. Either the surgeons or the patients hadn’t been willing to randomise, meaning they were essentially cohort follow-up studies.
It was clear that getting this trial off the ground would be a huge challenge, but it was one Mr Goldberg and the TARVA team were convinced they could pull off. First, however, there was the question of funding.
With a budget of over £1.2 billion, the NIHR (the National Institute of Health Research) is the UK’s largest funder of clinical and public health research. The team’s timing proved opportune, as the NIHR were in the process of putting together a call for surgical trials when they approached.
The field, however, was incredibly competitive, a factor compounded by a lack of existing data, as Mr Goldberg explains “The first question for the reviewers was, ‘How big a problem is it?’ and we couldn’t quote the orthopaedic literature which typically tends to say the problem is, ‘common and increasing’.
“So we had to carry out a lot of feasibility work, for example to publish the demand incidence for ankle arthritis, showing that 30,000 people in the UK were seeking advice of specialists for their symptoms. We also looked at how patients decide on their surgery type, most relying on the information given to them by their surgeon”.
Their hard work paid off in demonstrating a compelling need and proposition because out of nearly 300 applications, their bid was successful. With more than £2 million of funding in place, recruitment started in 2016.
More than 300 patients took part. Each was assigned, at random, to one of two surgical groups (TAR or ankle arthrodesis) and given assessments and questionnaires – first before their operation, and then at six, 12, 26 and 52 weeks after surgery.
Initial results brought positive news for patients. Both treatments proved safe and were clinically and cost effective. While the study found no overall superiority of one treatment over the other, it did uncover some subtle differences, for example, a certain type of TAR implant, known as a fixed bearing implant, seemed to outperform ankle fusion, while the presence of adjacent joint arthritis also seemed to point to an advantage of an ankle replacement over an ankle fusion.
Looking forward to the future
Beyond the end of the initial trial report, patients will be sent questionnaires at regular intervals – two, five and 10 years. This way, the team hope to capture important long-term outcomes.
“This was always meant to be a long-term study,” says Mr Goldberg. “What's going to happen in five, 10 years from now – that’s the exciting bit.
“For example,” he continues, “a paper published many years ago looked at patients years after their ankle fusion. All of them had adjacent joint arthritis show up on X-rays, so the evidence suggests a theoretical advantage of protecting the adjacent joints if we retain motion in the ankle. But it's only theoretical…”
In order to get some clarity on the casual relationship between fusion and adjacent arthritis, all patients in the TARVA trial were given an MRI scan before their treatment. This gives the team vital information on the health of the surrounding joints. “This was a really important factor in our study,” Mr Goldberg continues. “It was robust because the randomisation process was designed to ensure equal numbers of patients with surrounding joint arthritis were allocated to each treatment group, therefore removing bias, which is a particular problem with surgical trials. Without preoperative data, it’s impossible to answer the burning questions which we hope to address in due course”.
So TARVA is a trial that will provide answers for years to come. Perhaps this extended utility was one of the reasons the Roger A. Mann award panel chose TARVA to be the first recipient of this prestigious honour outside of America?
“Winning the Roger Mann Award at the American Orthopaedic Foot & Ankle Society was really amazing, and yet very humbling,” says Mr Goldberg. “It's nice to be recognised, but the award really belongs to the numerous surgeons and NHS Trusts that helped make this study happen.”