Lengthening bones – changing people's lives
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New approach in Limb Lengthening
What must a 3rd generation Limb Lengthening system be able to do to make a quantum leap in performance and fulfill the newest trends in healthcare driven by Value-Based Healthcare and Personalized Medicine initiatives?
Limb Lengthening procedures were pioneered and made popular by Prof. Gavril Ilizarov, a Russian orthopedic surgeon, and his external fixator frame more than sixty years ago.
Since Ilizarov’s day there have been many copies and renditions of his famous frame, and his procedures are now performed around the world.
In the early 2000’s, expanding implantable nails using a procedure similar to intramedullary nailing were first used. The expense of these nails was offset by the reduced pain, less scarring, and less interruption to patient’s lives. The first generation nails promised a lot, but had their own set of problems. The second decade of the new millennium has introduced a second generation nail offering a degree of superiority over the fifteen year-old technologies.
The third generation needs to promise more than just an advancement in nail technology, it needs to be a complete package solution, offering a quantifiable improvement in outcomes and a new level of personal experience for both surgeons and patients.
How can a 3rd generation Limb Lengthening system change the users’ experience? What will a 3rd generation Limb Lengthening system have to do to achieve a dramatic leap in patient outcomes?
The concept of products alone, e.g., Limb Lengthening frames or implants is passé. Many surgeons and patients may not know it today, but the trend is towards solutions that in the hands of anyone will improve the users’ personal performance and experience.
External fixators remain the standard and continue to offer the flexibility to handle complex or highly deformed Limb Lengthening cases. However, there are well-documented disadvantages due to complications, which given today’s technology needlessly impact a patient’s quality of life.
It is often said: “today’s problems, were yesterday’s solutions”.
The second generation nails offer advantages over external fixators, especially in allowing patients to unobtrusively undergo the procedure and rehabilitation.
In the hands of very specialist surgeons, today’s second generation nails support reproducible outcomes. However, are these second generation nails complication free? The somewhat obsessive drive towards ever-smaller nails, widens the opportunities for the procedure. Nonetheless, they are not necessarily in the best interest of all patients – who would not want to return to full weight bearing immediately after the surgery? Simply put, thinner nails may be less stable and therefore risk of breakages is higher, thus preventing normal use of the limb.
The key to 3rd generation nails is to provide a complete solution that can be safely applied by more surgeons, benefit more patients, and ensure a positive user experience.
The new Limb Lengthening technology must impact and change the user experience and outcomes like the iPhone did to the mobile phone industry.
That is the challenge, a challenge worth pursuing, and from the users’ perspective a challenge worth demanding.
The foundation of a 3rd generation Limb Lengthening system
It’s fashionable to launch ever-smaller nails to open the opportunity for lengthening procedures in smaller boned people. That’s OK, however, when you want guaranteed results, full weight-bearing and return to past activities, then the strength, robustness, and security of the intramedullary nail becomes a critical success factor.
Predictability is defined as the degree to which a correct prediction or forecast of a system's state can be made. The critical success factor in Limb Lengthening is about utilizing the right technologies to attain certainty: fail-safe predictability and precision in the elongation of the nail to achieve the lengthening desired by the patient and the surgeon.
All products claim that they facilitate control; however, it is control that truly differentiates 3rd generation systems from the rest of the field. The biggest factor leading to poor control in current generation products is the human factor – user errors and inability to follow the treatment plan – combined with the lack of tools for following the treatment progress. The 3rd generation system will remove the human factor and improve the controllability of the treatment.
Every surgeon and patient wants to have confidence and trust in the solutions they choose. How will a surgeon define “safety” in tomorrow’s evermore-litigious healthcare environment? The Internet has changed how patients can learn about their disorder and possible treatments; there is now no reason not to understand the safety issues of every Limb Lengthening procedure.
The 3rd generation Limb Lengthening solutions will completely change peoples’ view and appreciation of safety. Today people focus on product safety. The 3rd generation approach covers product safety, but considers treatment process safety too.
3rd generations solutions will not be compromised by a surgeon’s experience or on a patient’s demographics, compliance in terms of load-bearing, capability to recall nuances of the lengthening protocol or future activities.
A safe Limb Lengthening solution should provide a combination of products and services that aims to achieve and offer a 100% guarantee in outcome reproducibility across all stakeholders involved in the treatment.
For many Limb Lengthening patients the home period where distraction and osteogenesis occurs can be a time of great pain, frustration and inconvenience. Helping patients through this process enhances their experience and improves their outcomes.
How would you expect a 3rd Generation Limb Lengthening solution to change today’s negative experiences during the home care period?
It was not so long ago, that patients with external fixators had the somber choice of staying in hospital during the entire distraction period or being sent home with a “do-it-yourself” kit consisting of spanner and screwdriver. The real fun begins when you forget the protocol!
Thank goodness modern healthcare has moved on since then, or has it? There are still some limitations in using traditional strong magnets in the home environment and that correct use of the external control units require strict supervision with the second generation nails. The user errors reduce the controllability of the nail and have negative effect on the predictability of the treatment outcomes.
We live in the second decade of the 21st Century; such home care procedures should be relegated to the past. What will patients expect in terms of home-care in the future with the new 3rd Generation Limb Lengthening solutions? Following the trends in personalized healthcare we can anticipate: total control and predictability during the distraction stage, AND with a high level of customer convenience and ease of use.
Who is SYNOSTE?
SYNOSTE is a Finnish venture, which was started in 2007 by three young engineering students Harri, Antti, and Juha studying at Aalto University, Finland. The company was established in Helsinki in 2012 and expanded to Germany the following year.
Their passion, skills and competencies have led them to develop a solution for millions of people less fortunate than themselves – people suffering from bone deformities…
The three founders were just normal, fun-loving students who gradually built up expertise in the management of smart materials, micro mechanics and wireless technology.
What set them apart from their student colleagues was their drive to be entrepreneurs – not working for someone else. They decided to pool their competencies, skills and know how to correcting different types of bone deformities – people with curved backs (Scoliosis) or people whose two legs or arms were not of equal length (Limb Length Discrepancy, LLD).
They decided to prioritize creating an application for LLD because today’s standard of care was based on technology over sixty years old and was known for its high complication rates.
What they didn’t realize was that they had chosen one of the toughest and most challenging areas in orthopedics. However, history teaches us that some of the world’s best and life changing innovations have come when the inventor was unwittingly naive enough to rise to impossible challenges.
Technology trends in Limb Lengthening
Increasing use of strong bio-compatible shape memory alloys, which predictably contracts and expands upon heating or cooling. The predictability provides insurance for the surgeon and the patient – lengthening can be totally controlled.
A modern wireless technology is not just about transferring energy. It can sense, communicate and give feedback for the patient and surgeon about successful positioning and lengthening.
Modern biocompatible superalloys will enable the 3rd generation nails to allow full weight bearing and normal walking from day one without nail breakages and unwanted backtracking.
Having access to an independent and trusted self-support community helps patients to make better decisions.
Orthopedic & Spine surgeon, Professor
ORTON Orthopaedic Hospital, Helsinki
A “community of practice”, supports life-long learning by enabling surgeons to continually and freely share and exchange their experiences.
Professor in Traumatology and Sports medicine
Success in terms of Patient Reported Outcomes needs to be measured and driven by the patients themselves.
Peter H. Thaller
Reconstruction Surgeon, Head of 3D-Surgery
Ludwig-Maximilian-University of Munich
Eminence-based education has been replaced by learner-oriented training that truly prepares a surgeon and enhances their competencies.
Lengthening and deformity surgery in adults and children
We need three 'best things' to get best outcomes in bone lengthening journey; Surgeon, Patient compliance, and Lengthening device.
Limb lengthening and Reconstruction Surgeon
Yonsei University, Seoul, South Korea
Meet the team
SYNOSTE’s business is built around the vision, know-how and scientific expertise of the three founding engineers who transferred their university research into innovative products with a good cause. The three founders have committed everything to developing their vision – SYNOSTE is their passion; they have invested their time, their energy and what capital they had into this venture.
Project Manager, R&D Engineer
Principal Mechanical Engineer
Medical and Regulatory Affairs
SYNOSTE is a small dynamic team; we are passionate about the development of our first product to help people suffering with Limb Lengthening Discrepancy, so we would be very happy to share information with you during our journey.
We believe in co-operation, as we don’t have all the answers. So if you have ideas to help surgeons and patients, contact us and let’s make things better together!
Tel. +358 45 179 6300
SYNOSTE Germany GmbH