*Wrist Implants Made by Rapid Tooling Using Stereolithography With Injection Mold Engineering
Philip Schormans, trauma surgeon and researcher at Maastricht UMC+ and consultant trauma surgeon at the Amphia Ziekenhuis Breda, is the project leader for WISE. He explains that ‘hand and wrist injuries account for approximately 20% of all visits to Dutch emergency departments and are among the most expensive of all type of injuries. A known consequence of severe wrist trauma is post-traumatic wrist osteoarthritis, which can lead to severe functional impairment, pain, and occupational disability. Clinical results of available surgical treatments are disappointing; replacing cartilage by patient-specific and rapidly produced wrist implants can really make the difference. These patient-specific implants may enable patients to perform their daily activities free of pain while preserving mobility in the affected wrist joint.’
‘Every patient has their own life experiences, like playing hockey or boxing, that slightly reshape the wrist,’ explains Aylvin Dias, principal scientist at DSM. ‘This also affects the way the wrist wears out and the trauma it creates. Performing a CT scan gives us customized data on the wrist, which can be used to manufacture the correct implant, either by moulding or direct printing. An evaluation by the National Institute of Clinical Excellence in the UK has shown that customized implants result in more rapid recovery and reduce hospitalization time – and they’re also better for patients. This combination will really drive a trend towards more customized implants in the future. The biggest challenge is for the legal and regulatory frameworks to keep up with that trend.’
Expertise from three of InSciTe’ s partners has been brought together in WISE. Philip explains that ‘the department of trauma and orthopaedic surgery at Maastricht UMC+ is a tertiary referral center for complex post-traumatic wrist injuries. In addition, the orthopaedic research group has vast experience in cartilage replacement research. This combination has proven to be very synergistic in the course of this project.’ Aylvin adds: ‘We are working together closely with Xilloc Medical, one of the pioneers and market leaders in 3D-printed, patient-specific implants. DSM will be the manufacturer, and we will participate in manufacturing the implant. We are providing the materials as well as quality documentation. The biggest added value from InSciTe is time to market: InSciTe’s experience in crafting projects using the Biomedical Accelerator matrix ‘BEAM-NL’ really accelerates the process toward clinical implementation.’
The project can adapt to challenging timelines. How is that possible? ‘Part of the work has already been done in previous research that InSciTe has now revitalized, and DSM has developed a material that has already been approved for implantation,’ says Alvin. ‘Plus, through InSciTe, we have previous experience in first-in-man studies and regulatory testing. We are gaining experience as a group here, and InSciTe is becoming more and more of an experience incubator for ideas.’
How will the team translate the results into clinical implementation? ‘Even though the material for the wrist implants has been approved, there is still a lot of pre-clinical testing to do. We expect to perform the first-in-man implant in August 2021,’ says Philip. ‘While we focus on developing the best possible patient care, other team members are already working on business development, e.g. looking for a business framework and possible partners, as well as the possibility for implants in other joints. I believe that the knowledge gained from this project regarding the rapid production process of patient-specific implants will greatly change the way we will treat patients in the near future.’
Drs. Philip M.J. Schormans has obtained his medical degree in 2010 and has been working as a registered surgeon and trauma surgeon since 2018. In 2018 he did a fellowship in academic trauma surgery at the Maastricht UMC+ where he focused on hand and wrist surgery and has started numerous research projects in the field of hand and wrist surgery. Next to his research at the department of trauma surgery he has been working as a trauma surgeon at the Amphia Ziekenhuis in Breda, the Netherlands since 2019.
Aylvin Dias is the Principal Scientist and global competence manager for material – biology interactions at DSM. He obtained his B.Sc, M.Sc and PhD at University of Kent at Canterbury. After his PhD he worked at Total Chemie on printing materials for food packaging. In 1996 he joined DSM in the Netherlands. In the first 5 years he worked on optical fiber and stereolithographic materials. Since 1999 he established the biomedical research program and thereby was one of the founders of DSM Biomedical. The research program lead to the launch of 2 new medical coatings a lubricious coating and an antimicrobial coating that fall under the Comfort Coat TM first generation products. He then went to establish a drug delivery group and managed technology transfer of the polyesteramide polymer. Aylvin Dias has over 30 patents and 25 peer reviewed publications. He has served as chairman of the supervisory board of Xilloc Medical bv in 2013 and on advisory panel at the University Medical Centre Utrecht, The Netherlands and POLY division of the American Chemical Society and was President of the Surfaces in Biomaterials Foundation in 2015.