China: 3D Printed Vertebral Body Used to Reconstruct Upper Cervical Spine of 9 Patients

Primary osseous spinal tumors make up roughly 5% of all primary bone tumors, and reconstruction is required to restore the spine’s integrity and stability. However, it’s hard to reconstruct this complex section, which is responsible for transitioning the axial loading force from the cranium to the spinal column, and subpar implants can result in complications like migration and nonfusion.

3D printing can be used to fabricate patient-specific porous implants for fixing these bone defects. A group of researchers from Beijing published a study, “Upper cervical spine reconstruction using customized 3D-printed vertebral body in 9 patients with primary tumors involving C2,” where they described “the clinical outcomes of upper cervical spine reconstruction using customized 3D-printed vertebral body,” with “a mean follow-up of 28.6 months” for the patients.

“Patients with primary tumors involving C2 who were treated in our institution between July 2014 and November 2018 were enrolled,” the team stated.

“Nine patients (2 males and 7 females) were included in the study with a mean age of 31.4 years (12 to 59 years). Seven patients demonstrated tumors located in C2 and 2 showed involvement of C2 and C3.”

The nine patients initially complained of “aggravating pain,” with two suffering neurological impairment, and average duration since the onset of these symptoms was almost three months. Here’s the tumor breakdown for the patients, established using a CT-guided biopsy:

  • 4 giant cell tumors (GCT)
  • 2 chordoma
  • 1 Ewing sarcoma
  • 1 paraganglioma
  • 1 aggressive hemangioendothelioma

Fig. 1: Imaging studies for patient #3. The achievement of osseointegration was defined when new bone formation was observed around the bone-implant interface on X-ray (B) and CT (D) during the follow-up compared to that of immediately postoperative (A,C). The postoperative segment vertebral height was measured on the midsagittal reconstruction CT from atlas anterior tubercle to the midpoint of the adjacent lower endplate (C).

Making the implants was a 7-day process. First, CT scans were performed on the patients’ spines, and the DICOM data was imported into Materialise Mimics 15.0 software, where a CAD model for the implant was designed. Ti6Al4V powder was used to print the porous metal scaffold implants with Arcam EBM’s electron beam melting technology.

“Based on our previous studies, the parameters set for the trabecular structure and the size of the uniform micro-pores were determined to generate the optimized biomechanical and osteoinductive properties (,,). The upper contact surface morphology of the implant coincided with the inferior articular surfaces of C1, while the lower contact surface morphology coincided with the upper endplate of the caudal vertebra,” they wrote.

Fig. 2: The 3D printed artificial vertebral body with porous scaffold fabricated out of titanium alloy powder.

A two-stage intralesional spondylectomy was performed on each patient, and the 3D printed vertebral body was used to accomplish anterior reconstruction, without the use of a bone graft.

“The average interval between the posterior and anterior procedures was 14.4 days,” the researchers said.

“In the first 4 cases in this series, occipitocervical fixation was performed (Figure 1). Subsequently, with more confidence in the stability of the 3D-printed anterior construct, we were able to preserve the atlanto-occipital joint in the next 5 cases.”

If you’re interested in the rest of the nitty-gritty surgical details, check out the full research paper.

Table 1: The details of the 9 patients

In the table above, you can see the details of the patients, who all had follow-up appointments after the 3D printed vertebral body was implanted. All nine received postoperative radiotherapy, while two also received chemotherapy.

“Patient one died of systemic metastases 15 months postoperatively without signs of local recurrence. Patient seven had tumor local recurrence. The others were alive and functional in their daily livings at the last follow-up without evidence of disease. At their final follow-ups, the neurological status of all alive patients was ASIA E, and the average VAS score was 0.9. Three patients had ECOG 1, while 5 patients had ECOG 0 for their general well-being and activities of daily life,” they stated.

Fig. 3: Imaging studies for patient #3.

Through radiograph and CT examinations, the researchers observed new bone formation around the bone to implant contact surfaces, “which provided the evidence of osseointegration,” and they found that all of the 3D printed vertebral bodies were stable, without any signs of ” implant displacement or subsidence.” Additionally, none of the screws had come loose, and there was no rod breakage in the posterior instrumentation systems.

The researchers found several advantages to using 3D printing for this reconstruction rather than traditional methods of manufacturing, such as the implant offering “reliable primary immediate postoperative stability.” A patient-specific implant provides a better match to bony surfaces and a larger contact area, and because screw tracks are actually integrated directly into the artificial vertebra, “self-stabilization” occurs.

Fig. 4: Imaging studies for patient #6 showing fusion process. Compared to the immediate postoperative X-ray (A) and CT (D), regenerated osseous tissue can be seen to have gradually grown along the implant 12 months (B,E) and 24 months (C,F) post-op (arrow).

“Secondly, the anatomical design of the contact surface of the curved porous endplate and its biocompatibility provided reliable mid-long-term stability. The porous bone-contacting surface of the 3D-printed vertebral body is conducive to bone in-growth into the trabecular pores to achieve firm osseointegration, which was supported by evidence from previous basic research and in vivo studies (,,),” they explained.

Additionally, post-op radiotherapy may not affect the 3D printed vertebral body as much, so long as osseointegration on two ends occur, “because solid combination was accomplished.” Conversely, this treatment can lead to instrumentation failure with conventionally manufactured implants.

“In our study, the progress of osseointegration is evident on follow-up with imaging studies. On lateral radiography, regenerated osseous tissue was seen adhering to the 3D-printed vertebral body (Figures 1B,4B,C1B,4B,C).),” the researchers noted. “Sagittal CT revealed new bone tissue crawling and growing around the ends of the 3D-printed vertebral body from the upper and lower vertebra (Figures 1D,4E,F1D,4E,F).). All patients were capable of resuming normal activity without mechanical pain associated with spinal instability at 12-month follow-up.”

Finally, a 3D printed vertebral body could mean there’s less of a need for transoral (direct access through the mouth) or transmandibular surgical approaches. For example, as noted above, this research team used the posterior-anterior approach to perform C2 spondylectomy, which made it easier and safer to isolate the vertebral arteries.

“Our study suggests that 3D-printed implant may be a good option in upper cervical reconstruction, the tailored shape matching with the contact surfaces and the porous structure conductive to osseointegration provide both short- and long-term stability to the implant,” the researchers concluded. “However, a higher level of evidence is still needed.”

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Nexxt Spine Increases Investment in GE Additive’s Concept Laser Metal 3D Printing

Founded in 2009, Indiana-based medical device company Nexxt Spine first invested in metal 3D printing two years ago, with the purchase of its first Concept Laser Mlab 100R system. The company works in the expanding spinal cage sector and is working to increase procedural efficiency and patient outcomes for those suffering from debilitating spinal conditions. While Nexxt Spine originally used more traditional manufacturing methods to fabricate specialty spinal plates, rods, and screws, the business is scaling rapidly and increasing its metal additive investment with the installation of its fourth and fifth Mlab 100R systems from GE Additive this month.

Alaedeen Abu-Mulaweh, the director of engineering at Nexxt Spine, stated, “Additive is booming.”

Nexxt Spine aims to drive medical device innovation, and designs, manufactures, and distributes all of its spinal implants from its Noblesville facility. With its latest 3D printer purchase, the company is looking to, as GE Additive put it, “tap further into the growing global spinal implant market.”

“We are seeing ongoing adoption of additive manufacturing in the orthopaedic industry and an exciting shift from research and development to serial production,” said Stephan Zeidler, senior global and key accounts director for the medical sector at GE Additive. “Early innovators like Nexxt Spine are scaling up and there is a significant increase in production volumes.”

By continuing to invest in Concept Laser’s LaserCUSING metal 3D printing technology, which has been used in medical and military applications, to name just a few, Nexxt Spine is able to eliminate the need for contract manufacturers. Because it now owns the whole design, production and distribution process on-site, the company can increase how quickly it develops and commercializes its spinal implants.

Alaedeen Abu-Mulaweh

“We used the first Mlab primarily for R&D purposes, but we soon realised that further investment in additive technology could add value not only to our overall growth strategy, but also at a clinical application level with the ability to develop implants with very intricate micro-geometries that could maximise healing,” Alaedeen explained. “Over the past two years, we have made a seamless jump from R&D to serial production and in doing so have significantly accelerated the time from concept to commercialization.

“Like I said, additive is absolutely booming. It is driving our business and innovation strategy forward and our design team is actively developing and testing new applications, parameters and surgical devices to target new markets. We are excited for what the future holds for us.”

Nexxt Spine knows what it’s talking about when it comes to designing, developing, and fabricating spinal fusion implants – its products use interconnected micro-lattice architectures to promote osteoconduction, osteointegration, and boney fusion. A flagship product introduced in 2017 is the company’s Nexxt Matrixx System, which includes multiple porous titanium spinal fusion implants that combine novel 3D printed cellular scaffolding with highly differentiated surface texturing technology.

The company blends cellular porosity that’s inspired by the natural biology of bones with the underlying fundamentals of engineering in order to create fusion-optimized, structurally sound medical devices. This is a big difference from other medical manufacturers that use 3D printing to create devices which merely mimic the trabecular geometry of bone.

“Titanium – porous or otherwise – is physically incapable of biological remodeling, so using additive to directly mimic the structural randomness of bone doesn’t make a whole lot of sense,” Alaedeen explained. “Rather than simply looking like bone, Nexxt Matrixx® was designed with functionality in mind to fulfil our vision of actively facilitating the body’s natural power of cellular healing.”

Now that Nexxt Spine has shifted to serial additive manufacturing production and moved all of its design, manufacturing and distribution functions on-site in Indiana, it will be able to service customers and scale up as much as it needs to continue meeting the increased demand for better spinal fusion implants.

Zeidler concluded, “Nexxt Spine is another great example that shows the power of our Mlab machine, which is proven to be an easily accessible machine for research & development, with the capability to be a reliable, scalable and modular production machine at the same time.”

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[Images provided by GE Additive]

Captiva Spine Receives FDA Clearance for 3D Printed Titanium Lumbar Cages

3D printing has been playing a big role in helping people with spinal conditions over the last few years, particularly in terms of implants and other medical devices. But none of these 3D printed spinal solutions can get too far without the necessary clearance from the FDA. Florida-based Captiva Spine, Inc., a privately owned medical device organization that was founded in 2007, recently received 510(k) clearance from the FDA for its 3D printed TirboLOX-L Titanium Lumbar Cages.

“With the advanced capabilities of 3D Additive Manufacturing we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone ingrowth and vascularization,” said Dennis Ty, the Director of R&D of Captiva Spine. “Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

The company helps spine surgeons, healthcare facilities, and tenured spine distributors that work to provide patients with progressive, high quality spinal care. It’s dedicated to providing elegant and intuitive spinal fusion solutions, such as its TirboLOX-L Titanium Lumbar Cages. This spinal implant uses 3D printing to form interbody fusion devices, made out of titanium alloy, with a double layer organic lattice structure.

The lattice structure has an open architecture, a micro-rough surface topography, and interconnected dual porosity. The architecture can help lower radiographic presence to ensure clear imaging, while implants that possess the latter two features have shown that they can promote bone ingrowth, ongrowth, and vascularization. In addition, Captiva’s TirboLOX-L has a high coefficient of friction, which, as the company puts it, “creates immediate bidirectional fixation.”

Some of the main benefits of 3D printed porous titanium alloy cages, like the TirboLOX-L lumbar cages made of Titanium Alloy (Ti-6Al-4V), is bone’s ability to successfully grow within its architecture, which can then help it achieve good kinematic properties. The TirboLOX-L Titanium Lumbar Cage also features the company’s Pivotec technology.

“I am pleased our development team was able to incorporate our proprietary Pivotec Pivoting TLIF Cage into TirboLOX,” said Dale Mitchell, the President and Founder of Captiva Spine. “Pivotec technology has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”

With FDA clearance, Captiva is now cleared to take its 3D printed TirboLOX-L Titanium Lumbar Cage to market. This device is also one of five new product launches that the company is featuring at the upcoming North American Spine Society (NASS) Annual Meeting later this month in Los Angeles. Stop by its booth #1649 at the meeting to see the other four.

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3D Printing News Briefs: June 29, 2018

In today’s 3D Printing News Briefs (the last one this month, how is the summer going by so quickly?!), a few companies are announcing special honors and recognitions, and then we’re sharing stories stories about some interesting new 3D printing projects, and finally wrapping things up before the weekend with some business news. Renishaw’s Director of R&D has been honored by the Royal Academy of Engineering, while MakerBot earned an important designation for its 3D printing certification program for educators and Renovis Surgical Technologies received FDA approval for its new 3D printed implant. Festo is introducing three new bionic robots, one of which is partially 3D printed, and CINTEC is using 3D printing for its restoration of a famous government house. GE wants to use blockchains for 3D printing protection, and ExOne announced a global cost realignment.

Royal Academy of Engineering Honors Renishaw’s Chris Sutcliffe

Earlier this week, the Royal Academy of Engineering (RAE) awarded a Silver Medal to Professor Chris Sutcliffe, the Director of Research and Development of the Additive Manufacturing Products Division (AMPD) for global metrology company Renishaw. This award is given to recognize outstanding personal contributions to British engineering, and is given to no more than four people a year. The Silver Medal Sutcliffe received was in recognition of his part in driving the development of metal 3D printed implants in both human and veterinary surgery, and also celebrates his successful commercialization of 3D printed products with several companies, including Renishaw, and the University of Liverpool.

“Throughout my career I’ve worked hard to commercialise additive manufacturing technology. As well as AM’s benefit to the aerospace and automotive sectors, commercialisation of AM and associated technologies has been lifechanging for those with musculoskeletal diseases,” said Sutcliffe. “The award celebrates the successes of the engineers I have worked with to achieve this and I am grateful to receive the award to recognise our work.”

MakerBot’s Certification Program for Educators Gets Important Designation

One of the leaders in 3D printing for education is definitely MakerBot, which has sent its 3D printers to classrooms all over the world. Just a few months ago, the company launched a comprehensive, first of its kind 3D printing certification program, which trains educators to become 3D printing experts and create custom curriculum for STEAM classrooms. An independent review of the program showed that it meets the International Society for Technology in Education (ISTE) standards, and it has earned the prestigious ISTE Seal of Alignment from the accreditation body. In addition, a survey conducted over the last three years of over 2,000 MakerBot educators shows that the percentage of teachers reporting that MakerBot’s 3D printers met their classroom needs has doubled in just two years.

“This data shows that MakerBot isn’t just growing its user base in schools. We’re measurably improving teachers’ experiences using 3D printing,” said MakerBot CEO Nadav Goshen. “Much of this impressive teacher satisfaction is thanks to the effort we’ve put into solving real classroom problems—like the availability of 3D printing curriculum with Thingiverse Education, clear best practices with the MakerBot Educators Guidebook, and now training with the new MakerBot Certification program.”

Earlier this week, MakerBot exhibited its educator solutions at the ISTE Conference in Chicago.

FDA Grants Clearance for 3D Printed Interbody Spinal Fusion System 

California-headquartered Renovis Surgical Technologies, Inc. announced that it has received 510(k) clearance from the FDA for its Tesera SA Hyperlordotic ALIF Interbody Spinal Fusion System. All Tesera implants are 3D printed, and use a proprietary, patent-pending design to create a porous, roughened surface structure, which maximizes biologic fixation, strength, and stability to allow for bone attachment and in-growth to the implant.

The SA implant, made with Renovis’s trabecular technology and featuring a four-screw design and locking cover plate, is a titanium stand-alone anterior lumbar interbody fusion system. They are available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles, with various heights and footprints for proper lordosis and intervertebral height restoration, and come with advanced instrumentation that’s designed to decrease operative steps during surgery.

Festo Introduces Partially 3D Printed Bionic Robot

German company Festo, the robotics research of which we’ve covered before, has introduced its Bionic Learning Network’s latest project – three bionic robots inspired by a flic-flac spider, a flying fox, and a cuttlefish. The latter of these biomimetic robots, the BionicFinWave, is a partially 3D printed robotic fish that can autonomously maneuver its way through acrylic water-filled tubing. The project has applications in soft robotics, and could one day be developed for tasks like underwater data acquisition, inspection, and measurement.

The 15 oz robot propels itself forward and backward through the tubing using undulation forces from its longitudinal fins, while also communicating with and transmitting data to the outside world with a radio. The BionicFinWave’s lateral fins, molded from silicone, can move independently of each other and generate different wave patterns, and water-resistant pressure and ultrasound sensors help the robot register its depth and distance to the tube walls. Due to its ability to realize complex geometry, 3D printing was used to create the robot’s piston rod, joints, and crankshafts out of plastic, along with its other body elements.

Cintec Using 3D Printing on Restoration Work of the Red House

Cintec North America, a leader in the field of structural masonry retrofit strengthening, preservation, and repair, completes structural analysis and design services for projects all around the world, including the Egyptian Pyramids, Buckingham Palace, Canada’s Library of Parliament, and the White House. Now, the company is using 3D printing in its $1 million restoration project on the historic Red House, which is also known as the seat of Parliament for the Republic of Trinidad and Tobago and was built between 1844 and 1892.

After sustaining damage from a fire, the Red House, featuring signature red paint and Beaux-Arts style architecture, was refurbished in 1904. In 2007, Cintec North America was asked to advise on the required repairs to the Red House, and was given permission to install its Reinforcing Anchor System. This landmark restoration project – the first where Cintec used 3D printing for sacrificial parts – denotes an historic moment in structural engineering, because one of the reinforcement anchors inserted into the structure, measuring 120 ft, is thought to be the longest in the world.

GE Files Patent to Use Blockchains For 3D Printing Protection

According to a patent filing recently released by the US Patent and Trademark Office (USPTO), industry giant GE wants to use a blockchain to verify the 3D printed parts in its supply chain and protect itself from fakes. If a replacement part for an industrial asset is 3D printed, anyone can reproduce it, so end users can’t verify its authenticity, and if it was made with the right manufacturing media, device, and build file. In its filing, GE, which joined the Blockchain in Transport Alliance (BiTA) consortium in March, outlined a method for setting up a database that can validate, verify, and track the manufacturing process, by integrating blockchains into 3D printing.

“It would therefore be desirable to provide systems and methods for implementing a historical data record of an additive manufacturing process with verification and validation capabilities that may be integrated into additive manufacturing devices,” GE stated in the patent filing.

ExOne to Undergo Global Cost Realignment

3D printer and printed products provider ExOne has announced a global cost realignment program, in order to achieve positive earnings and cash flow in 2019. In addition to maximizing efficiency through aligning its capital resources, ExOne’s new program will be immediately reducing the company’s consulting projects and headcount – any initial employee reductions will take place principally in consulting and select personnel. The program, which has already begun, will focus first on global operations, with an emphasis on working capital initiatives, production overhead, and general and administrative spending. This program will continue over the next several quarters.

“With the essential goal of significantly improving our cash flows in 2019, we have conducted a review of our cost structure and working capital practices. We are evaluating each position and expense within our organization, with the desire to improve productivity. As a result, we made the difficult decision to eliminate certain positions within ExOne, reduce our spending on outside consultants and further rely on some of our recently instituted and more efficient processes,” explained S. Kent Rockwell, ExOne’s Chairman and CEO. “Additional cost analyses and changes to business practices to improve working capital utilization will be ongoing over the next several quarters and are expected to result in additional cost reductions and improved cash positions. All the while, we remain focused on our research and development goals and long-term revenue growth goals, which will not be impacted by these changes, as we continue to lead the market adoption of our binder jetting technology.”

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