If Patients Only Knew!
The need and demand for total joint replacement is rapidly increasing despite a number of impediments. Covid the world over has delayed many non-life-threatening operations and lockdown has meant many people have taken up more exercise which will result in healthy people with new interest in activity for many years which inevitably puts wear and tear on hip and knee joints in particular. Covid has probably also made many aware of the value in being more active and it is perhaps a useful conundrum that the last year has meant that many people should live longer, happier lives by enjoying exercise and being fitter. However, many will need implants, and some last longer and allow the patient to perform better than others.
Patients put up with whatever ‘the system’ gives them; but NHS and Private health companies are focused on saving costs of implants by getting bundled deals with large corporations as the priority over implant performance. Purchasers of implants and clinicians are expected to take account of the National Joint Registry (NJR) and Orthopaedic Data Evaluation Panel ODEP ratings but many implants used are not the best performers. The world is massively dominated by three large American implant companies vying for market share with glossy marketing claims but do they sell the most advanced implants?
Once diagnosed, patients can research implant devices for themselves on the internet and, like all products, they vary a lot. Research can provide implant options not always made clear to patients by surgeons who are increasingly told what to use and often prefer not to change to learn another device however good it is.
National Joint Registries (NJR) UK and Australia particularly, and ODEP ratings are available for patients to research different implants for; – likely longevity, performance measures, satisfaction scores, e.g. Forgotten Joint Score.
Only the patient has the ultimate interest in satisfaction and longevity. The best outcomes for patients will be with the best implants in the hands of the best surgeons. Patients can ‘shop around’ for which implant and surgeon they want. Better performing implants cost very little if any more than the cheapest.
Total Knee Replacement
Total Knee Replacement (TKR) has poor patient satisfaction compared to hip replacement.
Most dissatisfaction for TKR is due to instability when performing basic activities including descending steps. The normal or native knee has a high degree of stability (forwards – backwards) due to its geometry of a medial (inside) ball-in-socket accompanied by ligaments each side of it.
TKR development in the USA evolved a mistake that has dominated designs since the 1980s which does not provide the natural ball in socket geometry. To overcome instability a post and cam arrangement has evolved (PS) but only works for the knee at more than 60 degrees of flexion, i.e. outside walking range! Its results are the poorest in National Joint Registries.
MatOrtho Ltd (formally Finsbury Orthopaedics), began implanting a more natural TKR design in 1994 (The Medial Rotation Knee™) providing a ball-in-socket like the normal knee which has consistently achieved the lowest re operation (revision) rates in NJR’s and higher patient satisfaction than other knee types. This has further evolved into the SAIPH® Total Knee Replacement from MatOrtho® which is set to change the landscape of total knee replacement. The Australian NJR has recognised that total knees can be separated into one of three ‘Stabilised’ types and established the ‘Medial Pivot’ design as distinct from ‘Posterior Stabilised’ and ‘Minimally Stabilised’. The powers at the AU NJR have mistakenly named it Medial Pivot which is a trade name for the implant licenced by Finsbury to Wright Medical in 1996. The correct description is ‘Medially Stabilised’, like the native knee! Which demands special features that cannot be ‘tacked onto’ existing knee devices
Total Hip Replacement
MatOrtho® only sells a Resurfacing Total Hip Replacement, it does not sell hip stems with modular heads. Surgeons throughout the world have a preference for a hip stem that is often mixed with a cup system from a different manufacturer. It is not commercially sensible for a small company like MatOrtho® to provide copy hip stems to go with an advanced cup system such as Finsbury developed in the groundbreaking DeltaMotion. This large diameter ceramic-on-ceramic system could be matched with any hip system with a compatible taper junction and ceramic head supplied by Ceramtec. DePuy J&J bought Finsbury for DeltaMotion in 2010, it has performed remarkably well and is especially appropriate for young active patients with small hips who want a normal range of motion and do not want to dislocate their hips. For patients who want to cross their legs, and squat this is a massive improvement to total hip replacement. It was unfortunately expensive to manufacture so DePuy have dropped it in favour of a product with better margin but without the advantages.
The plan by Mike Tuke from 2004 was to take development steps to culminate in a ceramic–on- ceramic Total Hip Resurfacing, a cup system that uses the same cup with ceramic heads as did the DeltaMotion but these cups to take a step beyond that design as a passing proof of concept by removing the metal shell and applying ceramic almost direct to bone utilising a coating only to provide fixation. Thus ReCerf® and DeltaRom® hip systems have been developed which further advance the head to cup ratio to improve range of motion and reflect a native size ball and socket for ALL patients.
A salutary fact that has emerged in favour of Hip Resurfacing even with Metal-on-Metal like the MatOrtho ADEPT® system is that of postoperative mortality. The registries have data that demonstrates a problem with total hips that introduce a stem into the femur which means that by 10 years the same patient has a higher likelihood of death than if they had a hip resurfacing. Arguments abound with respect to statistics and confounding factors but patients should be aware of this emerging data.
The Future for Innovation
MatOrtho®, and Finsbury before that under the leadership of Mike Tuke, has pioneered some of the most serious advances to replacement joints and the instrumentation to accompany them. Most companies have given up innovating devices and instead are selling ‘stories’, for example, that robots will provide a patient with a long term better outcome. This is true to a degree but only in so far as it removes some surgeon variables, it makes no difference to what the implant can provide, a poor design will still give poor performance. Robots increase the cost of each operation but there is no convincing proof of better patient outcomes compared with what a better implant can do.
Invention and innovation for implant devices is now threatened with extinction. MatOrtho is the last remaining independent UK orthopaedic company but now its development future is facing an end due to ridiculous over-regulation.
The EU CE system is changing the process for existing products as well as new developments which is making it almost impossible to continue to supply despite being able to demonstrate best in class long term results independently monitored by a number of national registries. This is a disaster for everyone. Many good existing products from all companies will be taken off the market as unviable and worse for the survival for small development companies like MatOrtho®. New product development is many years behind even the approval of existing devices, this is regulation gone mad, it has no practical way of being implemented as currently being insisted upon unless the EU regulators abandon the current out of control process.