When an orthopaedic in-patient tells visitors, ‘they had to put metal pins in,” the sympathetic murmurs normally assume it was ‘one of those titanium thingamajigs.”, writes Chris Bateman for MedicalBrief. Very soon that assumption will be misplaced – and the secondary surgery and anaesthesia often required to remove the titanium plate, pin or screw, unnecessary.
That’s because a new magnesium-based metal implant is disrupting the traditional titanium-based plates market world-wide, dramatically lowering infection risks while promoting quicker bone healing. The metal compound has previously unheard-of properties, organically assimilating into the bone once healing has taken place…
This disruptive breakthrough in bio-medical technology accelerates and improves the healing of serious fractures, with fast-growing children and adolescents among the biggest beneficiaries.
Despite common assumptions, difficult fractures or surgically-corrected bone deformities do not always grow back stronger. More often than not, they require metallic implants that can pose problems such as infection, irritation and discomfort. According to the medical literature, a full 81% of all orthopaedic surgeries that use a titanium-based implant require risky secondary surgery to remove the screw, plate or pin. The infection rate after secondary surgery is cited as up to 20% – with refracture after removal at 27%. For polymer-based implants, foreign body reactions stand at 27,9%, while breakage during surgery is 11,6%, with overall complications weighing in at a worrisome 39%.
Clearly medical technology faced a serious challenge. This is where the globally game-changing bio-technological solution by a multi-discipline-qualified German professor, Utz Claassen, 56, came to the fore. After several decades of experimentation, research and development, Claassen has come up with a bio-absorbable metal implant device made of bone-friendly magnesium. With inbuilt anti-infection properties, it is absorbed into the bone, disappearing entirely. This provides support for the bone in the time it takes to heal, strengthens it, increases flexibility and promotes and accelerates healing. The unacceptably high percentages cited above have, at a single stroke, been eradicated in one of the most disruptive advances in medical technology in recent history.
Says Claassen: “With other implants, the total complication risk is nearly 40%. Also, if you look at the literature on anaesthesia, the incidence rate of something undesirable happening while ‘under’ is between 10 and 40%, depending on the patient’s age. Even in advanced countries, the chances of irreversible damage with anaesthesia are about one in one hundred. My deep conviction is that any unnecessary surgery and anaesthesia that can be avoided has to be, even more so in children. There’s almost always traumatisation with surgery, so every single unnecessary surgery is at least gross negligence, one might even argue, a crime.”
Mimicking the human bone
The biomechanical properties of the implant, trade-marked as Magnezix, are very similar to those of human bone. Since the holding company Syntellix AG was founded in 2008, there are no recorded implant-related complications using this compound. One top German orthopaedic surgeon reported 800 surgeries with a 100% patient satisfaction rate. Not only are Magnezix implants proving clinically superior to other metals but any screws inadvertently or unavoidably left protruding are no longer a problem – they’re absorbed away. The metal compound also provides clean long-term MRI and CT scans, something the other metal implants cannot match.
Claassen has so far registered 160 derivatives of the screw and at last count (late August 2019) had sold more than 46,000 units worldwide. His team received feedback on 1088 of these devices of which 33 involved genuine clinically undesirable results – of which only four had to be reported to the health authorities. Further analysis and examination proved that not a single reported case could be attributed to the implant itself.
A former CEO of nuclear, solar energy and other biotech companies, plus a New York hedge fund, Claassen holds degrees in economics, business studies and industrial design, and considers himself an avid, life-long student. He’s studied brain inter-hemispheric relations and neuropsychological development and economics, writing a thesis on the connectivity between brain research and economics when he was 22.
His company has won every technical innovation prize available in Germany, not entirely surprising given they spent between half and 90% of their budget on research and development. Of Germany’s 36 university hospitals, six are now routinely using the new products and another 28 are in negotiations to use them. He expects a 100% ratio within a few years.
“We’re now working on products for neuro-surgery, which is a very big market, aesthetics and dental surgery, plus the veterinary market,” Claassen adds, describing Magnezix as especially helpful in cranial surgery closure and healing.
Asked to give some comparison in scientific history to quantify the technological leap his product represents, he responds; “the step from Newton to Einstein’s world is the same as the step from titanium to magnesium. This is the game-changer we’ve been waiting for. There’s huge patient advantage with no extra cost to the system across the entire value chain. It will save billions of dollars to health systems globally and over the next 20 years impact at least one billion people, exponentially improving their quality of life with benefits to the environment and society. In the same way steel was disrupted by titanium, magnesium is disrupting titanium,” he says.
He sees South Africa as the pioneering country on the African continent with a history of innovation and creativity. Already, six major local public academic hospitals are using it, having been convinced of the economic and patient-load-reduction benefits. Says Claassen: “What can be more profitable for the public sector than avoiding unnecessary surgeries? They can then use their limited capacity for higher value work than implant removals.”
Says Professor Gowreeson Thevendran, an internationally known orthopaedic surgeon at Raffles Hospital in Singapore: “In the five years I’ve worked with these implants, I have not seen any adverse effects in patients. They are as good as titanium, but have many advantages. I would call them the new gold standard in orthopaedic and trauma surgery.”
Bostman O, Pihajamaki H: Routine implant removal after fracture surgery: a potentially reducible consumer of hospital resources in trauma units. J Trauma.1996;41:846-9
Minkowitz RB, Bhadsavle S, Walsh M, Egol KA: Removal of Painful Orthopaedic Implants After Fracture Union. J Bone Joint Durg AM. 2007;89:1906-1912
Hanson B, van der Werken C, Stengel: Surgeon‘s beliefs and perceptions about removal of orthopaedic implants. BMC Musculoskeletal Disorders 2008, 9:73