Keith Tucker, FRCS, Chairman of the Orthopaedic Data Evaluation Panel (ODEP) and the Beyond Compliance Advisory Group discusses how real-world data is driving better decisions in orthopaedics
Across the UK, information collected through the National Joint Registry (NJR), alongside programmes such as Beyond Compliance and the Orthopaedic Data Evaluation Panel (ODEP), is providing an increasingly detailed picture of how implants perform in everyday clinical practice. Rather than relying solely on clinical trials or laboratory testing, surgeons and manufacturers can now understand how devices perform across thousands of patients, multiple hospitals and many years of follow-up.
This continuous flow of real-world evidence (RWE) is allowing surgeons and manufacturers to identify opportunities to improve devices and, ultimately, patient outcomes much earlier than would previously have been possible. Much of that evidence comes from registry data, which provides far more than overall revision rates. By analysing how implants perform in everyday clinical practice, it helps explain not just what is happening, but why.
Looking beneath the headline numbers
Sometimes, the overall performance of an implant can hide important differences between its individual components.
In one example, detailed analysis of registry data identified that while one component of a knee replacement was performing well, another component was showing early signs of loosening. Because the stronger-performing component masked the poorer results, the issue only became apparent after the data was examined in greater detail.
Once the problem had been identified, the component was redesigned before it became a more widespread issue. This demonstrates how carefully analysed data can identify emerging problems early enough for manufacturers to improve devices before larger numbers of patients are affected.
Improving how implants are used
Perhaps more importantly, registry data doesn’t just shape the next generation of implants. It is also helping surgeons get the very best from the devices already being used today.
Early data from one knee replacement entering the Beyond Compliance programme suggested the implant was underperforming. Rather than assuming there was a problem with the device itself, clinicians and data specialists at NEC Software Solutions dug deeper into the data.
They discovered that the implant performed well when the patella was resurfaced during surgery, but outcomes were significantly worse when it was not. Further analysis showed that the results for a small number of surgeons were flagging towards potential outlier status because they were using the implant without routinely resurfacing the patella. Following discussions with the Medicines and Healthcare products Regulatory Agency (MHRA), surgeons using the implant were advised to resurface the patella when using that device.
Following that change, patient outcomes improved significantly.
This is where real-world data comes into its own. Rather than highlighting problems after they have become established, it provides an opportunity to identify patterns early, understand their causes and make changes that improve patient care.
Changing behaviour across orthopaedics
The impact extends well beyond individual implants too. One of the biggest changes we’ve seen over the past two decades of using ODEP has been the way manufacturers engage with their own data.
Before the panel was established, there was little expectation that manufacturers would routinely analyse long-term clinical performance. Today, continuous evaluation has become an accepted part of introducing and supporting new implants.
Manufacturers now monitor outcomes much more closely. Surgeons increasingly consider ODEP ratings when selecting implants, while hospitals and procurement teams use them to support purchasing decisions. Real-world evidence has become part of everyday clinical decision-making rather than something reviewed only after problems emerge.
And the improvements a