A major national study will pitch human skill against machine precision as it compares the benefits of knee replacement surgery performed using a robot to a surgeon using traditional methods.
Knee replacements are now very common operations; over 100,000 procedures are performed each year in the UK. The RACER (Robotic Arthroplasty: a Clinical and cost Effectiveness Randomised controlled trial) study is set to compare the use of surgical robots to standard instruments in an effort to determine which of the two techniques is best at improving patient outcomes and reducing pain following surgery.
The study will be jointly run between University Hospitals Coventry and Warwickshire (UHCW) NHS Trust, Warwick Medical School at the University of Warwick, and the Royal Orthopaedic Hospital (ROH) in Birmingham.
The £1.6 million randomised controlled trial is funded by the National Institute for Health Research (NIHR) – the research partner of the NHS, public health and social care. With equal numbers of participants in each treatment group, a balanced and fair comparison can be made to find out which surgical technique results in better outcomes. This will include asking questions about people’s ability to do activities and their quality of life in the long-term and will also find out which method provides the best value for the NHS.
The surgeon performs the operation for both options in the study. They normally use instruments that provide pre-set angles to help them do the operation, but some surgeons have started using a robotic arm attached to a computer with a pre-prepared map of the leg to guide them.
Surgical robots are favoured by some for their precision and guidance, while standard instruments are preferred by others for their simplicity and ability to make greater of use of surgeons’ skills and experience, without the added expense.
The team will invite patients to take part from six NHS hospitals across England and Scotland over the coming months. The company that makes the robot, Stryker, will be supporting the study with costs to ensure hospitals do not have to pay extra to take part.
The study is being led by two surgeons, Mr Andy Metcalfe, from UHCW and Warwick Clinical Trials Unit at the University of Warwick, and Professor Ed Davis, from ROH.
Mr Metcalfe said: “Can robots help surgeons perform knee replacements better? This is a really important question and we’re delighted that the NIHR has agreed to support the study.
“Surgeons are always working to improve the care we give and we’re seeing more robots in surgery now. This study is about whether using a robot gives better results for patients having knee replacements and we’re looking forward to being able to answer that.
“It is a big achievement for the team to be at the forefront of a world-leading multi-centre study like this, it is probably one of the most important questions in orthopaedic surgery right now. We’re really pleased to be able to get started.”
Professor Davis added: “We are excited to begin this incredibly significant study. It will help orthopaedic surgeons across the world to better understand the most effective tools and techniques when performing knee replacements. It will also help us to ensure patients enjoy the very best outcomes.
“The team have all worked incredibly hard during the pandemic to ensure this trial is safe and of the highest quality. We are all very keen to evaluate the evidence and share it as widely as possible.”
Although the trial opened at the end of December 2020, activity was delayed by the Covid-19 response, when most orthopaedic services were paused. Some hospitals are now seeing patients again and the study is now accepting patients into its first sites.
The Royal Orthopaedic Hospital in Birmingham and the Royal National Orthopaedic Hospital in Stanmore, London, are already open for recruitment, with a number of other hospitals across the UK (including the Glasgow Royal Infirmary, the Royal Infirmary of Edinburgh, the Freeman Hospital in Newcastle, the Royal Devon and Exeter NHS Trust, and Portsmouth NHS Hospitals) expected to open soon.