Safe Introduction of the SAIPH® Knee
Discerning surgeons can now choose the SAIPH® Knee based on its evidence. If the enthusiasm of those at the Forever Active Forum 2018 is a reflection of data quality, the SAIPH® Knee is a good choice!
New technologies are essential
New technologies are essential to advance quality of care and surgeons who embrace those that succeed become leaders in their field.
But not all new technologies improve patient outcomes. Joint replacement technologies have been used in huge numbers around the world before clinical data emerged that ultimately showed that the technology was flawed. Such experiences inspired national joint registers to provide long-term, non-biased, multicentre data.
Surgeons are responsible for making decisions about the medical treatment of their patients based on careful appraisal of the available evidence. With good data, surgeon’s decision making is much easier, but when technology is new, the body of evidence is limited.
How can evidence-based decision making work with new technologies?
Some authorities and procurement groups take the view that technologies should not be used unless they have 10 years of registry data and ODEP 10A rating. If all parties maintained this view then nothing would ever achieve this point. But an approach taken by large mainstream manufacturers is to launch new technologies to many thousands of patients, effectively in a race to get to the point where registry data then demonstrates the device’s credentials. While some pay lip service to good initiatives such as Beyond Compliance, they are still implanting thousands around the world. In reality this is no safer than the approach of the technologies that failed.
In the wake of such failures, ‘innovation’ is being forced down the road of rebranding technologies or providing superficial technologies that do not directly benefit patients.
MatOrtho® is focussed on innovating new technologies and recognises that they have a part to play in answering the problem. Patient safety is indispensable and maintaining trust in innovation and finding a way to make it work is essential.
The responsible approach to new technology introduction
MatOrtho® introduces new technologies gradually and responsibly, so that as few patients as possible are exposed to potential risk of failure while, as the evidence grows, as many patients as possible can ultimately benefit. Proper surveillance ensures that surgeons can uphold their responsibility for evidence-based decision making.
A close analogy to this approach is Henrik Malchau’s ‘Stepwise Introduction’ algorithm1.
1 Pre-clinical testing
The first step for all new technologies is pre-clinical testing and provision of an evidence-base sufficient to obtain European Community (CE) Approval. While this is a licence to market a device, it does not provide sufficient evidence for many surgeons to provide the technology to large numbers of patients. This is when staged clinical release is planned and reviewed with an organisation such as Beyond Compliance who works with manufacturers to advise on a safe rate of introduction to market.
2 First clinical step
The first clinical step is to make the technology available to a small group of fully informed expert surgeons (usually the inventors) who provide the technology to a modest number of informed patients under strict conditions. Use of the technology is recorded by relevant national registers and it may receive an ‘ODEP Pre-Entry’ rating.
3 Second clinical step
Based on results of the first clinical step, a multicentre trial exposing the technology to a wider and independent community without susceptibility to performance bias can be initiated. This includes carefully prepared study controls and sufficient numbers of patients to allow adequate statistical analysis. Registry data may report on use of the device in small numbers and for 1-3 years, and ODEP ratings may be 3A or even 5A. ODEP 3A, 5A or 5B would mean that the device is on track to achieve a 10A and may even be showing better outcomes than others that already have a 10A* rating.
4 Wider release
Based on results of the second clinical step wider release of a technology can be pursued with continuous control groups such as those captured by national joint registries – the NJR and the NJRR used in the UK and Australia respectively are examples of this. Continued review of data including ODEP ratings is essential to ensure success continues to be demonstrated.
Support from technology adopters
Critics of the staged introduction approach would claim that it means that it takes too long for new technologies to become available to the patients who need it. However, despite real confidence in the SAIPH® knee, the inventor surgeons were firmly behind the initiative to release the device gradually, particularly in the wake of recent well-publicised ‘copy’ resurfacing designs.
Results from the first clinical step were sufficient for independent surgeons to enter into a SAIPH® Knee multicentre study. They were equally supportive of the initiative and this led to the organisation of the Forever Active Forum.
This approach with the SAIPH® Knee has found a good balance between carefully monitoring performance and gradually ‘opening the gates’. With the SAIPH® Knee we are seeing more genuinely satisfied patients and we have the data to show it!
So where are we now?
The SAIPH® Knee now has a very respectable evidence base on which surgeons can choose to use the device.
SAIPH® is associated with excellent data based on evaluation of sufficient numbers of patients to demonstrate that it is an advance compared to technologies that surgeons were using previously.
Further details can be found in the SAIPH® Knee Clinical Data Summary9.