Michael Barbella, Managing Editor11.15.21
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. Brian R. McLaughlin, president and CEO of Scarborough, Maine-based Amplify Additive, 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?
Brian R. McLaughlin: Much of the orthopedic sector is already using AM [additive manufacturing] or headed in the direction of AM/3D printing—for instance, if you are a spine company and don’t have a 3D printed titanium cage, you are behind, it’s as simple as that. The reasons include better fusion due to titanium being biocompatible (as opposed to PEEK that is bioinert), reduced 3D printed titanium density due to design optimization and use of lattice, and the overall manufacturability/cost. It is much more cost-effective to print cages than it is to machine PEEK.
In addition to the spine market, oncology and trauma are both market segments that can certainly leverage AM for better patient outcomes. Total joints—knees, hips, shoulders also leverage the technology to promote better initial fixation and better overall results. That is the key—AM provides better clinical outcomes.
Barbella: What benefits does additive manufacturing bring to the orthopedic industry?
McLaughlin: As mentioned previously, AM offers the opportunity for better clinical outcomes. For total hips, a benefit of 3D printed acetabular cups is initial fixation, which reduces incidences of malalignment and thus reduced dislocation. For total knees, the reduction of the use of cement conserves bone. Should a patient need revision surgery and need a replacement, aside from the bone in-growth that occurs with the 3D scaffolds, we can print this onto implants. For oncology and trauma, we can deliver customized solutions for the most challenging of situations, and in many cases save limbs and improve the quality of lives for patients. AM isn’t just a sexy new technology; it is a game-changer for the industry.
Barbella: What challenges are preventing wider scale adoption of additive manufacturing/3D printing in the orthopedic industry?
McLaughlin: The most significant challenge the industry faces is education around technology and growth. First, various platform technologies are available—both laser and EBM [electron beam melting]. While GE Additive’s Arcam EBM technology is the only commercially viable technology of its type, there are several laser platforms to choose from. Aside from choosing a platform, i.e., EBM or laser, there is a considerable understanding of all the software tools needed to make a product successful. Also, the cost to get in the game, so to speak, is significant with platforms ranging from $500,000 up to over $1 million for a single installation. After that, consider your facility, your team, and the knowledge of secondary to execute on a project thoroughly. Many have started the journey and have not been able to get there. The more successful companies have been the ones to internalize the capability, e.g., Stryker, with their investments in 3D metal printing. I think it is easy to state that they are the market leader when leveraging 3D printing for implants.
Barbella: How has additive manufacturing technology impacted/changed orthopedic implant innovation?
McLaughlin: AM has reduced the time to market for innovative implant solutions but keep in mind these innovative solutions were not previously able to be manufactured because AM works differently than traditional manufacturing technologies, allowing designs to be built layer by layer at a micron scale. With AM, implant solutions can be designed leveraging biomimicry. Biomimicry or biomimetics is examining nature, its models, systems, processes, and elements to emulate or take inspiration from life to solve human problems. The term biomimicry and biomimetics come from the Greek words bios, meaning life, and mimesis, meaning to imitate. For the first, AM allows us to leverage what we know about the human anatomy to optimize solutions for patients.
Barbella: What changes to additive manufacturing technology are spurring innovation in orthopedic implants?
McLaughlin: AM is changing rapidly, which has made it challenging for the industry to keep up in many cases. Some of those changes have to do with processing—faster using more lasers, more power to melt different materials, and better in-process inspection to eventually leverage machine learning and, ultimately, AI. We are not quite there yet, and with so many changes to AM systems, the regulatory effects are essential to consider with regards to different materials and process improvements. It is vital that companies that are enhancing technologies have a good understanding of the market and what the FDA could be thinking about regarding AM.
Barbella: How has software enhanced or impacted the design of 3D printed orthopedic implants?
McLaughlin: At Amplify Additive, we often ask ourselves if we are a manufacturing company or a software company with manufacturing capabilities. For design in today’s world of orthopedics, everything starts digitally, and software is an integral part of the process. Now take that, and add a layer for AM that wasn’t previously there with traditional manufacturing methods, which changes the approach to design. In order to leverage AM for good designs, the designer needs to understand the outputs of the AM machine. In understanding outputs based on specific software inputs, and then applying machine level process controls to those designs—that is where the rubber meets the road and where good inputs and understanding lead to innovative designs. A lack of understanding of the process relative to the design can lead to a poor experience and lack of execution.
Barbella: What challenges and/or opportunities are associated with using materials other than titanium for 3D printed orthopedic devices/implants?
McLaughlin: Titanium has been a gold standard for leveraging AM technology, whether laser or EBM. There is so much that can be addressed for implants just leveraging titanium, and we are a long way from realizing that full potential. That said, materials are the future of the industry. Think of CoCr as a material—it is heavy and has led to various clinical issues over the years—but it is still the standard of care for just about all articulating joints. Is there a material that could be 3D printed that could replace CoCr, or could CoCr be 3D printed? CoCr can be printed, we do know that, but the cost-benefit has not been close to realized, mainly because there isn’t even a resource in the U.S. that is printing CoCr for implants, as far as I am aware. We don’t have many answers about materials. Still, there is a lot of focus on materials in the industry at the moment, and investments in powder manufacturing companies continue to demonstrate that.
Barbella: Where do you see 3D printing in orthopedics headed in the next decade?
McLaughlin: I see 3D printing being a dominant force in the next five to 10 years and beyond. For now, we are able to develop innovative implant solutions that replace traditional manufacturing in many ways. However, we are still not able to address all materials for existing implants—plastics in particular. I do believe we will get there, but it is a race between printing existing materials, next-generation materials, and possibly biomaterials that will replace or regrow tissues. We need to focus on the education around existing systems to optimize the use of these technologies and focus on making investments in this area. Without investments in this area, there will not be scaled growth of AM, and the development for innovative implant solutions will be constrained.
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. Brian R. McLaughlin, president and CEO of Scarborough, Maine-based Amplify Additive, 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?
Brian R. McLaughlin: Much of the orthopedic sector is already using AM [additive manufacturing] or headed in the direction of AM/3D printing—for instance, if you are a spine company and don’t have a 3D printed titanium cage, you are behind, it’s as simple as that. The reasons include better fusion due to titanium being biocompatible (as opposed to PEEK that is bioinert), reduced 3D printed titanium density due to design optimization and use of lattice, and the overall manufacturability/cost. It is much more cost-effective to print cages than it is to machine PEEK.
In addition to the spine market, oncology and trauma are both market segments that can certainly leverage AM for better patient outcomes. Total joints—knees, hips, shoulders also leverage the technology to promote better initial fixation and better overall results. That is the key—AM provides better clinical outcomes.
Barbella: What benefits does additive manufacturing bring to the orthopedic industry?
McLaughlin: As mentioned previously, AM offers the opportunity for better clinical outcomes. For total hips, a benefit of 3D printed acetabular cups is initial fixation, which reduces incidences of malalignment and thus reduced dislocation. For total knees, the reduction of the use of cement conserves bone. Should a patient need revision surgery and need a replacement, aside from the bone in-growth that occurs with the 3D scaffolds, we can print this onto implants. For oncology and trauma, we can deliver customized solutions for the most challenging of situations, and in many cases save limbs and improve the quality of lives for patients. AM isn’t just a sexy new technology; it is a game-changer for the industry.
Barbella: What challenges are preventing wider scale adoption of additive manufacturing/3D printing in the orthopedic industry?
McLaughlin: The most significant challenge the industry faces is education around technology and growth. First, various platform technologies are available—both laser and EBM [electron beam melting]. While GE Additive’s Arcam EBM technology is the only commercially viable technology of its type, there are several laser platforms to choose from. Aside from choosing a platform, i.e., EBM or laser, there is a considerable understanding of all the software tools needed to make a product successful. Also, the cost to get in the game, so to speak, is significant with platforms ranging from $500,000 up to over $1 million for a single installation. After that, consider your facility, your team, and the knowledge of secondary to execute on a project thoroughly. Many have started the journey and have not been able to get there. The more successful companies have been the ones to internalize the capability, e.g., Stryker, with their investments in 3D metal printing. I think it is easy to state that they are the market leader when leveraging 3D printing for implants.
Barbella: How has additive manufacturing technology impacted/changed orthopedic implant innovation?
McLaughlin: AM has reduced the time to market for innovative implant solutions but keep in mind these innovative solutions were not previously able to be manufactured because AM works differently than traditional manufacturing technologies, allowing designs to be built layer by layer at a micron scale. With AM, implant solutions can be designed leveraging biomimicry. Biomimicry or biomimetics is examining nature, its models, systems, processes, and elements to emulate or take inspiration from life to solve human problems. The term biomimicry and biomimetics come from the Greek words bios, meaning life, and mimesis, meaning to imitate. For the first, AM allows us to leverage what we know about the human anatomy to optimize solutions for patients.
Barbella: What changes to additive manufacturing technology are spurring innovation in orthopedic implants?
McLaughlin: AM is changing rapidly, which has made it challenging for the industry to keep up in many cases. Some of those changes have to do with processing—faster using more lasers, more power to melt different materials, and better in-process inspection to eventually leverage machine learning and, ultimately, AI. We are not quite there yet, and with so many changes to AM systems, the regulatory effects are essential to consider with regards to different materials and process improvements. It is vital that companies that are enhancing technologies have a good understanding of the market and what the FDA could be thinking about regarding AM.
Barbella: How has software enhanced or impacted the design of 3D printed orthopedic implants?
McLaughlin: At Amplify Additive, we often ask ourselves if we are a manufacturing company or a software company with manufacturing capabilities. For design in today’s world of orthopedics, everything starts digitally, and software is an integral part of the process. Now take that, and add a layer for AM that wasn’t previously there with traditional manufacturing methods, which changes the approach to design. In order to leverage AM for good designs, the designer needs to understand the outputs of the AM machine. In understanding outputs based on specific software inputs, and then applying machine level process controls to those designs—that is where the rubber meets the road and where good inputs and understanding lead to innovative designs. A lack of understanding of the process relative to the design can lead to a poor experience and lack of execution.
Barbella: What challenges and/or opportunities are associated with using materials other than titanium for 3D printed orthopedic devices/implants?
McLaughlin: Titanium has been a gold standard for leveraging AM technology, whether laser or EBM. There is so much that can be addressed for implants just leveraging titanium, and we are a long way from realizing that full potential. That said, materials are the future of the industry. Think of CoCr as a material—it is heavy and has led to various clinical issues over the years—but it is still the standard of care for just about all articulating joints. Is there a material that could be 3D printed that could replace CoCr, or could CoCr be 3D printed? CoCr can be printed, we do know that, but the cost-benefit has not been close to realized, mainly because there isn’t even a resource in the U.S. that is printing CoCr for implants, as far as I am aware. We don’t have many answers about materials. Still, there is a lot of focus on materials in the industry at the moment, and investments in powder manufacturing companies continue to demonstrate that.
Barbella: Where do you see 3D printing in orthopedics headed in the next decade?
McLaughlin: I see 3D printing being a dominant force in the next five to 10 years and beyond. For now, we are able to develop innovative implant solutions that replace traditional manufacturing in many ways. However, we are still not able to address all materials for existing implants—plastics in particular. I do believe we will get there, but it is a race between printing existing materials, next-generation materials, and possibly biomaterials that will replace or regrow tissues. We need to focus on the education around existing systems to optimize the use of these technologies and focus on making investments in this area. Without investments in this area, there will not be scaled growth of AM, and the development for innovative implant solutions will be constrained.