Ground breaking approach to recruitment of patients in nationwide clinical trial

A new clinical study being run at NNUH promises to provide a major breakthrough in the treatment of ankle arthritis.

The clinical trials industry is worth in excess of £30bn yet in the UK, yet recruitment of patients is a known major barrier to successful research, with several pharmaceutical companies having pulled out of the UK after failing to recruit patients.

A national study led by the Royal National Orthopaedic Hospital (RNOH) in partnership with UCL is looking to reverse this trend with the TARVA study; involving surgeons from NHS centres across the nation. The study will investigate whether total ankle replacement is a more effective treatment for ankle arthritis than arthrodesis, which involves the fusing of ankle bones.

TARVA is using unique recruitment channels, following helpful suggestions from Channel 4’s Jon Snow, who spoke at the Orthopaedic Surgical Trials event at the Royal College of Surgeons, which includes social media and an online information video, to encourage patients to become involved in the study and to help educate them in the process.

Ankle arthritis affects up to 30,000 people across the UK each year. The condition sees shock absorbing cartilage being worn down which leads to bones rubbing against bone. This in turn causes stiffness and pain which can have a major effect on a person’s quality of life.

Total ankle replacement is an operation that replaces worn-out ankle joints with metal and plastic components and allows a gliding motion between the tibia (in the leg) and talus (in the foot). This is similar to other replacement surgeries, such as hip or knee replacements. Total ankle replacement is often a successful operation and it is estimated that more than 80% of ankle replacements will still be in place 10 years after surgery.

The more commonly used treatment for ankle arthritis is ankle arthrodesis, which involves fusing the worn-out arthritic joint, meaning that the ankle bones are joined together or made into one. Approximately 2,000 ankle fusion surgeries take place each year in the UK.

Actor Sylvester McCoy (Dr Who / The Hobbit) agreed to help the TARVA team engage with patients by starring in an Award winning* patient information video aimed to help engagement and understanding**. Patients with ankle arthritis identified as possible candidates will be shown the video at the screening stage with a view to being invited to join the trial. The video can also be accessed through the trial’s website ( 

It is hoped that the TARVA study will offer vital evidence on which is the best course of treatment for patients who suffer with this condition and the one which offers best value to the NHS.

Mr Andy Goldberg, Consultant Orthopaedic Foot and Ankle Surgeon at the RNOH and Associate Professor at UCL, who is leading the study in Stanmore, said:

“Ankle arthritis causes pain and misery for thousands of people across the UK so we’re really excited to be delivering this national study, which could bring new hope to patients with the condition.

“We have involved patients and the public at every step so far, including in the design of the study as well as the outcome measures we shall capture and the tools we are using to engage with potential study participants.” He continued: “Traditionally clinical trials have relied on a doctor mentioning a study when they are in front of a patient. This means hundreds of potential study patients just don’t know about the study. With the help of many experts in the national spotlight we are turning things around, by allowing patients to find out about us, through the media and the web.”

Consultant Orthopaedic Surgeon Mr. D Loveday at NNUH says “We are delighted to be part of this very important study and to innovate new ways of running research, which is in line with NNUH agenda and mission to ensure our patients receive the highest standards and quality of care.”

For further information please contact 01603 286706  

TARVA stands for Total Ankle Replacement Versus Ankle Arthrodesis. The study is being run by the Comprehensive Clinical Trials Unit (CCTU) at UCL and its lead centre, the Royal National Orthopaedic Hospital in Stanmore and Central London. It is funded by more than £1m of support from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Scheme which is the UK’s largest funding body for medical research. The study started recruiting patients in March 2015 and aims to recruit 328 patients with severe ankle arthritis aged between 50-85 years within 18 months. The Trial video recently won a New Media Award for the Best Patient Education and Recruitment Video. TARVA will involve NHS centres across England, Scotland and Wales.