3D Printing Opportunities Abound in Orthopedics

Knee osteoarthritis treatment is getting personal.
 
University of Bath (U.K.) researchers have devised a knee realignment system using customized high-tibial osteotomy (HTO) plates made from 3D printed titanium. The plates fit almost perfectly when implanted, thanks to an improved surgical technique also developed by university engineers.
 
“Knee osteoarthritis is a major health, social, and economic issue, and does not receive as much attention as it should,” said Professor Richie Gill, of the university’s Centre for Therapeutic Innovation. “A quarter of women over 45 have it, and about 15 percent of men, so it’s a significant burden that many live with. Knee replacement is only useful for end-stage osteoarthritis, so you can be in pain and have to live with a disability for a long time, potentially decades, before it’s possible. We hope the new TOKA process we’ve developed will change that.”
 
Tailored Osteotomy for Knee Alignment (TOKA) aims to improve HTO plate fit and cut OR time four-fold (from two hours to 30 minutes). The procedure uses a 3D CT (computed tomography) scan to create a customized HTO plate and surgical guide that fit the patient’s shin bone as perfectly as a jigsaw puzzle piece. The HTO plates have already been tested in a virtual in-silico trial, and data from the 28 participants convinced U.K. regulators to greenlight a study in Britain. Hospitals in Bath, Bristol, Cardiff, and Exeter are expected to participate in the randomized controlled study to compare patient outcomes with an existing generic HTO procedure.
 
The TOKA technique also is undergoing testing in Italy, where 25 patients have received customized HTO plates in a trial conducted at the Rizzoli Institute in Bologna.
 
“The HTO surgery has a long clinical history and it has very good results if done accurately. The difficulty surgeons have is achieving high accuracy, which is why we have created the TOKA method, which starts with a CT scan and digital plan,” Gill said. “3D print the custom knee implant and doing the scanning before operating means surgeons will know exactly what they’ll see before operating and where the implant will go. In addition to a surgeon being able to precisely plan an operation, a surgical guide (or jig) and a plate implant, each personalized to the patient, can be 3D printed automatically based on the scanning data. Importantly, this type of treatment relieves the symptoms of knee osteoarthritis while preserving the natural joint.”
 
Natural joint preservation and better implant fit are just two of the many advantages of fabricating implants via 3D printing (a.k.a., additive manufacturing). The technology has expanded rapidly in the orthopedic sector in the past decade because it can create more natural anatomical shapes and porous bone replacement scaffolds that allow for natural bone ingrowth, thus ensuring better implant stability.
 
ODT’s feature “Printer Friendly” explores the ways in which 3D printing is improving orthopedic implant design and patient outcomes. Adam M. Clark, CEO of Fairborn, Ohio-based Tangible Solutions Inc., was among the half-dozen industry experts interviewed for the story. His full input is provided in the following Q&A.
 
Michael Barbella: Please discuss the additive manufacturing/3D printing trends currently driving and shaping the orthopedic industry. Have these trends changed of late?
Adam M. Clark: The top two drivers are the maturing base of contract manufacturers who provide 3D-printed titanium orthopedic Implants and operate under FDA regulations and guidelines. Over the last 10 years, there have been a number of companies throwing their hat into the ring of additive manufactured implants. There are some well-known failures, but the manufacturing side has evolved to support the level of quality expected by orthopedic OEMs. 
The second is design software. There are major advancements and a growing pool of competitors in this arena. The translation from design software to additive manufacturing machines has enhanced greatly over the last couple of years, along with the expertise in people that lies in between. Orthopedic companies now realize the value of the latest level of innovation and can intentionally design smaller, intentional features and still achieve consistency across the product line that has fantastic results for the patient. 
 
Barbella: What benefits does additive manufacturing bring to the orthopedic industry? 
Clark: Additive manufacturing brings another tool to the tool belt in the industry. It’s not applicable to everything and it’s finding success in particular niches aligned with particular strategies. There has been a significant amount of trial and error within the industry and we as a whole are starting to see where the technology applies. Once there is an application, it’s followed by accelerated use.
 
Barbella: What challenges are preventing wider scale adoption of additive manufacturing/3D printing in the orthopedic industry?
Clark: There are misconceptions about the ease of movement into additive manufacturing and perhaps this can be an opportunity to reset the expectations for the industry. This is a technology that was developed 30 years ago. Over time, it has made its way to more production-oriented use. With that, additive manufacturing found niches within the broader realm of the manufacturing industry and medical has taken advantage of the technology.   
 
Barbella: How has additive manufacturing technology impacted/changed orthopedic implant innovation?
Clark: There is a design evolution happening before our eyes. We are part of a Renaissance in the orthopedic industry. Masterpieces are coming to market more frequently. Outside the “Big Five,” finding a solid partnership is to your advantage right now, as the Big Five continue to bureaucratically print their way into losses. Everyone has access to this technology, but the expertise and experience with AM technology on the OEM side is still in its infancy but rapidly changing.
 
Barbella: What changes to additive manufacturing technology are spurring innovation in orthopedic implants?
Clark: There was a  technology innovation plateau about two years ago in additive manufacturing technology itself. The biggest Innovations are happening in software and ancillary/supporting technologies.
 
Barbella: What challenges and/or opportunities are associated with using materials other than titanium for 3D printed orthopedic devices/implants? 
Clark: Every material has its own challenge and a significant reason we are solely focused on 3D-printed titanium orthopedic Implants. However, though there are challenges, there are opportunities associated with new materials that can lead to better outcomes for patients. Developing new materials is a very costly process in many aspects. 
 
Barbella: Where do you see 3D printing in orthopedics headed in the next decade?
Clark: 3D printed implants will continue to expand their market share exponentially over the next five to six years. We are barely past the infancy stage of additive manufacturing in orthopedics, so there is a long road ahead and plenty of opportunity for the application of the technology. It’s going to take a while for additive manufacturing to find solid footing in large joints. Other sectors like spine, foot and ankle, craniomaxillofacial, and others are accelerating their use of the technology. There is another wave of opportunity in the form of printed surgical guides and tools to planning models. Getting instruments into the field can be very costly, and with the quickening evolution of materials and feasibility, orthopedic OEMs are applying the consideration of additive manufacturing to more than just implants.