A range of groundbreaking genetic tests can help predict whether joint replacements work or fail. These new genetic tests are poised to help the UK achieve its goal of becoming a world’s leading ‘scientific superpower’ by 2030, according to UKRI.
The Medicines and Healthcare products Regulatory Agency launched ExplantLab orthotic pattern tests this week at the Artificial Intelligence in Orthopedic Conference at the Royal College of Surgeons.
The tests were developed with support from Innovate UK and the Academic Health Sciences Networks of North East and North Cumbria, in collaboration with:
North Tees University Hospital
Nuffield Health Tees
Hospital for Special Surgery, New York
Royal Perth Hospital, Australia
Bone composition tests identify genetic markers in saliva or blood samples for specific differences in human leukocyte antigen (HLA) genes, which regulate immune responses.
These genes indicate whether patients will develop an allergic reaction to cobalt chromium, a type of metal found in many joint replacement implants.
Anticipate the risks
David Langton of ExplantLab explains:
By sequencing DNA in saliva swabs and blood tests from more than 600 joint replacement patients around the world, we have demonstrated that those who experienced complications carry specific variations of the HLA gene family.
We then used our findings to develop a machine-learning algorithm called Orthotype that uses genetics to accurately predict whether a patient is at risk of responding to a joint replacement made from the component cobalt chromium (CoCr), often referred to as an allergic reaction to a joint implant.
Innovation is necessarily driven
The pandemic has seen the number of hip and knee replacements drop, due to pressures on the NHS. There is still a large backlog of cases that have led to increased waiting times.
The problem was compounded by not all joint replacements being successful. Worldwide, it is estimated that 10% to 20% of procedures performed are revision surgeries, where the original implants failed. Up to 44% of failed knee replacements show evidence of an adverse knee joint reaction.
In addition, about 20% of patients return after surgery with joint pain. Genetic testing that can help reduce the harmful effects of implants may help reduce the need to manage chronic pain after surgery and repeat surgery.
This will help deliver orthopedic care and better health outcomes for patients as well as reduce NHS waiting lists.
Innovation in orthopedics
Mr Jeremy Latham, Consultant Orthopedic Hip Surgeon in Southampton, said: ‘We know that the majority of patients have excellent outcomes after joint replacement surgery. However, some people experience an adverse reaction to implants made of cobalt chromium alloy.
Using Orthotype will help us identify these patients so we can make better decisions about the best transplant for them. In the age of personalized medicine and shared decision making, this is the kind of innovation we should embrace in orthopedics.
Why do artificial joints fail?
While joint replacements tend to be successful, a significant number of patients return after surgery with unexplained pain and inflammation that can lead to implant failure.
Sometimes this is because the joints have become unstable or injured, but over the past two decades, an allergic reaction to “debris,” or metal particles, from the joint implant has increasingly been recognized as a contributing factor.
In addition to chronic pain and inflammation, this can cause irreversible tissue damage. In severe cases, people can develop an autoimmune response to their implants, leading to a more serious disorder known as “metal hypersensitivity.” In these cases, joint revision surgery may be recommended.
Information is empowerment
Sally, 66, from Leeds, has been suffering from knee pain for over 40 years. She said:
When the pain started to stop me from doing the things I wanted, like hiking, I knew I needed some help. My doctor started discussing knee replacement surgery. I heard about Orthotype research in the news and thought getting the test done before surgery would be a good idea.
Sally auditioned for humanitarian reasons from ExplantLab prior to launch.
The test was easy at home, she said, and she mailed it in. Two weeks later I learned I had the genes that might make me more likely to react poorly to the most common knee replacement implants.
Having this information is helpful because my doctor can use it to choose the best type of implant for me, which makes me feel more confident in getting UKRI reviews of my surgery.
It is hoped that the launch of the Orthotype system will herald a new surgical era of personalized medicine in orthopedics where individuals undergo genetic testing before receiving implants.
Innovate UK, which partially funded the research into Orthotype, believes it will ease the burden on patients and an already struggling health service. Orthotype’s use in standard clinical practice is also further evidence of Britain’s burgeoning innovation in science and technology.
Richard Hebdon, Director of Health and Life Sciences at Innovate UK, said: As health systems come under increasing pressure to serve a growing elderly population, it is imperative that we see more movement towards personalized medicine.
The traditional “one size fits all” approach simply will not meet the increasing complexity of society’s needs. Therefore, innovations such as Orthotype, which inform and enhance clinical decision making on a personal and business level, will be vital in enabling fit-for-purpose transformation.
A shift that could help cement Britain’s position as a leader in scientific innovation on the international stage.
First-in-class genetic testing
The MyOrthotype saliva-based home test kit for preoperative joint replacement patients is available to order online via the ExplantLab website.
Surgeons and physicians can order more detailed blood-based copies of orthopedic tests via the pathology laboratory services of their hospitals. This includes a common post-operative test that can be used to diagnose metal sensitivity in people who have already had surgery.