SOUTH WINDSOR, Conn., Feb. 17, 2020 /PRNewswire-PRWeb/ -- Oxford Performance Materials, Inc. (OPM), an industry leader in advanced materials science and high-performance additive manufacturing (HPAM®), announced today the publication of "A Comparative Study of Three Biomaterials in an Ovine Defect Model: A TETRAfuse® PEKK Study" in The Spine Journal.1,2,3 This study examined the in vivo material characteristics of polyetheretherketone (PEEK), titanium-coated PEEK, and 3D printed polyetherketoneketone (PEKK) in a sheep model. In comparison with PEEK, the PEKK implants displayed bone ingrowth, no fibrotic tissue formation, a significant increase in bony apposition over time, and a significantly higher push-out strength.
Conventionally, PEEK and Ti-coated PEEK have been used as standard biomaterials for implants like spinal interbody cages, but recent shortcomings in these materials have led to adoption of newer, more innovative technologies. Although PEEK shows an elastic modulus comparable to that of cortical bone, literature has illustrated that it consistently prompts a fibrotic and inflammatory tissue response, preventing it from integrating with host tissue. And while titanium exhibits similar osseointegrative properties when compared to PEKK, it is substantially stiffer than cortical bone and it is radiopaque, which makes bone fusion assessments difficult as the bone/implant interface is often obscured in post-operative imaging. With titanium coated PEEK implants, these drawbacks still exist but with the added risks of delamination of the titanium coating, subsidence, and the generation of wear debris.
"The results reported by The Spine Journal were gratifying and support the comparative benefits of 3D printed PEKK implants that we have been hearing from surgeons for some time, now," said Scott DeFelice, CEO. "OPM's OsteoFab® technology platform is increasingly recognized as a 'best of' solution for CMF and spinal implants, and we will be launching our unique 3D printed suture anchor product in the coming weeks."
3D printed PEKK delivers high mechanical integrity, radiographic visibility, and osseointegration, as well as inherent antibacterial characteristics.4 In this Spine Journal study, PEKK demonstrated a significantly higher push-out force when compared to PEEK at 8 and 16 weeks post-implantation and also had notably greater bone attachment following pushout when compared to PEEK and Ti-coated PEEK. From a histological standpoint, 3D printed PEKK also showed substantial bone growth. Within a 2mm radius of the implant, 3D printed PEKK exhibited the highest bone ongrowth percentage when compared to PEEK and Ti-coated PEEK at both the 8- and 16-week endpoints.
By directly comparing the three implant materials in an in vivo model, the study showed clear evidence of the performance characteristics at the bone-implant interface. In this instance, 3D printed PEKK presented a high propensity for bone-ingrowth, no radiographic interference, and a material structure that allowed for an increase of integration of cancellous bone into the implant. In a clinical scenario, 3D printed PEKK implants could improve the effectiveness of spinal fusion procedures by promoting osseointegration and decreasing the chance of complications associated with PEEK and Ti-coated PEEK.
Since 2013, OPM has been manufacturing patient-specific cranial and facial implant devices that have been distributed world-wide. In addition to over 2,300 craniomaxillofacial implants, OPM has 3D printed over 70,000 OsteoFab® implants under a number of 510(k) clearances and just recently entered the sports medicine arena with a soft tissue fixation device. As the pendulum shifts away from traditional material solutions, OsteoFab® 3D printed PEKK is proving to be a robust alternative with a rapidly growing user base.
About Oxford Performance Materials, Inc.
Oxford Performance Materials was founded in 2000 to exploit and commercialize the world's highest performing thermoplastic, PEKK (poly-ether-ketone-ketone). OPM's Materials business has developed a range of proprietary, patented technologies for the synthesis and modification of a range of PAEK polymers that are sold under its OXPEKK® brand for biomedical and industrial applications. The Company is a pioneer in 3D printing. OPM Biomedical's OsteoFab® technology is in commercial production in numerous orthopedic implant applications, including cranial, facial, spinal, and sports medicine devices. OPM is the first and only company to receive FDA 510(k) clearance to manufacture 3D printed patient-specific polymeric implants and has six 510(k) clearances in its portfolio. OPM Industrial produces 3D printed OXFAB® production parts for highly demanding applications in the energy, transportation and semiconductor markets. OXFAB® structures offer significant weight, cost, and time-to-market reductions that are defined in a set of specified performance attributes in the exhaustive OPM B-Basis database, developed in conjunction with NASA. For more information, please visit: http://www.oxfordpm.com
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1. Cheng, PhD B, Jaffee S, Swink I, Averick, PhD S, Horvath S, Zhukauskas, PhD R et al. A Comparative Study of Three Biomaterials in an Ovine Bone Defect Model: A TETRAfuse® PEKK Study. The Spine Journal. 2019. doi: 10.1016/j.spinee.2019.10.003
2. RESULTS paragraph from the Study abstract reads: "PEKK implants demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to standard PEEK. The PEKK implant displayed bone growth characteristics comparable to Ti-coated PEEK with significant improvements in implant integrity and radiographic properties."
3. Note: TETRAfuse® is a Registered Trademark of RTI Surgical, Inc. and the tradename for RTI's spinal implants that are additively manufactured by Oxford Performance Materials, Inc. using OPM's proprietary OsteoFab® technology platform. TETRAfuse® was awarded a 2019 MedTech Breakthrough Award for "Best New Technology Solution – Orthopedics" and a 2018 Spine Technology Award from Orthopedics This Week.
4. Wang M, Bhardwaj B, Webster T; Antibacterial properties of PEKK for orthopedic applications. Int'l Journal of Nanomedicine. 2017: 12 6471-6476.
SOURCE Oxford Performance Materials