Centre-to-Centre (C2C) Collaborative Partnership

The NSF-ERC for Revolutionizing Metallic Biomaterials (RMB), the CÚRAM SFI Centre for Research in Medical Devices, and the Nanotechnology and Integrated Bioengineering Centre (NIBEC) at Ulster University have formed a Centre-to-Centre (C2C) collaborative partnership for the development of advanced metallic biomaterials capable of supporting regenerative biological functions through their use in innovative orthopedic biomedical implants. The partners have multi-faceted, complementary, and, we propose, synergistic talents.

Intellectual Merit: The US based ERC-RMB, comprised of North Carolina Agricultural & Technical State University (NCAT), with its recognized materials research and processing capabilities; the University of Pittsburgh (Pitt), with expertise in bioengineering, biomaterials and regenerative medicine; and the University of Cincinnati (UC), with expertise in smart nanotechnology, engineered systems and test beds, will collaborate with CÚRAM the SFI Centre for Research in Medical Devices (SFI), based at the National University of Ireland Galway, with its innovative approach to both traditional and new combinational modelling of next generation medical devices from multi-scale design to device manufacturing and with the Nanotechnology and Integrated Bioengineering Centre (NIBEC), based at the Ulster University Jordanstown Campus, with expertise in medical instrumentation, sensors, diagnostic systems, surface science and biomaterials coating strategies will collaborate under the auspices of the US-Ireland R&D program to develop critical enabling technologies that are necessary for the effective application of novel magnesium (Mg) alloys exhibiting ultra-high ductility, high strength and toughness in areas of patient care related to orthopedic devices for complex fracture fixation. We propose to develop biodegradable orthopedic implants made from novel high strength, high ductility Mg and Mg alloy systems to replace the permanent metals/metal alloys currently used, in orthopedic implant applications ranging from thin wires to thicker pins, rods and elastic stable intramedullary nails (ESINs), as well as meshes, for the treatment of bone fractures. We propose to use both existing high purity Mg systems and new alloys of Mg currently being developed by ERC-RMB, by multiple novel (patents pending) processing methods, in this work. In addition to using them in their inherent state we will employ advanced surface modification and coating procedures to control the key properties necessary for the clinical applications concerned. We will use stateof-the-art modeling techniques to provide the data necessary to target multiple orthopedic applications by variations in alloy bulk and surface properties. Central to this effort will be the development of specialized orthopedic implant devices for pediatric use, which have several major benefits.

Broader Impacts: In addition to the broader technical and translational impact of resorbable orthopedic implants for the treatment of complex fractures, the C2C team will promote a culture of entrepreneurship that supports creative, adaptive and innovative global engineers. The C2C will create excitement and participation by students (from undergraduate through doctoral level) in the area of biomaterials and related areas, especially among women, socially and economically disadvantaged, and African-American students. Further, it will foster a culture of innovation in bioengineering research and education and provide for entrepreneurship and economic development that will help the USA and Ireland succeed in a global economy by directly engaging small innovative firms, industries and practitioners and technology transfer officers. Our highly effective ERC web seminar series will continue and will be leveraged to include this C2C program, as appropriate, using remote access facilities to provide the necessary links. Our multi-university trans-ERC courses will also be extended to include the C2C international partners. It is expected to draw new enrollments from RMB, CURAM and NIBEC students across institutional boundaries to promote “outside the box” thinking in the 21st century workforce, and to aid individuals to find permanent employment in a wide range of industrial and governmental positions. This tripartite collaboration can have a strong impact on the next generation workforce, with particular emphasis on students having opportunities for study-abroad activities, spending time conducting research at both academic and industrial partner research sites (USA, Ireland, and Northern Ireland). All the graduate students participating will have research advisory committee members from all the 3 university center partners, and industry members, as appropriate.

 

Achievements for 2017:  US-Ireland- Northern Ireland R&D partnership between the NSF-ERC for Revolutionizing Metallic Biomaterials (ERC-RMB) in the US and CÚRAM at NUI Galway, Ireland, NIBEC at Ulster University, Northern Ireland: NSF-SFI-C2C

 

What have you accomplished thus far with your C2C supplement?

  • Seven conference calls and webinars with technical presentations have occurred, with the entire C2C team, along with industrial partners OrthoKinetic, Inc, NC, USA and Ft. Wayne Metals (FWM) IN, USA that focused on details of bioresorbable orthopedic implants made from novel high strength, high ductility magnesium and magnesium alloy systems that can replace the permanent metals/metal alloys usually used in applications ranging from thin wires (for clinical use as “k wires”) to thicker pins, rods and elastic stable intramedullary nails (IMs or ESINs), as well as meshes for the treatment of complex bone fractures.
  • Materials Transfer agreements, MOUs, NDAs have been signed among the C2C and Industry members.
  • First set of key biodegradable magnesium alloy systems developed by the NSF-ERC-RMB using novel alloy processing methods (invention disclosures filed) have been shipped to NIBEC at Ulster University. Ulster has employed advanced surface modification and coating procedures to control key interfacial properties for our clinical applications. 
  • First stage finite element models have been developed at the Science Foundation Ireland Centre for Research in Medical Devices (CÚRAM) at the National University of Ireland, Galway (NUIG) that model 3-point bending tests for samples with and without corrosion and IM in-bone insertion.
  • Clinicians from Ireland and the US have supplied surgical requirements for k-wires and IMs. Appropriate animal models are being explored in initial tests based on these requirements.
  • Patrick Lemoine from Ulster University visited ERC-RMB during summer 2017
  • ERC-RMB members at NCAT and UC have produced Mg alloy rods and wires through single crystal formation or thermomechanical extrusion for in-vivo, in- vitro experiments
  • Mg Intramedullary Bone nails (IMs), provided by ERC groups and industrial partner (FWM), were tested for biomechanical properties (2017). All but one type of Mg IMs had sufficient strength to withstand insertion and extraction pressures, using pig cadaveric fore-leg bones.
  • A 4-point bending protocol was refined, involving a UC bioengineering inter, to fulfill ASTM F1264 standards, with reduced support spacing for smaller specimens. It is hypothesized that the stiffness of Mg IM nails needed to be ~ 25-50% that of current IMs and testing of ERC-RMB materials is planned.
  • Multiple types of surgical nails for C2C are being produced using single crystal technology and ERC-RMB magnesium alloys. Proprietary methods developed by ERC-RMB are being used to prepare surgical meshes made of magnesium.
  • Dr. Pat McGarry (CÚRAM the SFI Centre for Research in Medical Devices (SFI), based at the National University of Ireland Galway), has hired personnel and they are working on the computational modeling of the bone and Mg materials.
  • NCAT is finishing preparation of a Mg materials data base and will shortly release it to both academic and industrial members. A subset of mechanical properties of ERC-RMB alloys produced at NCAT and Pitt was provided to industrial team members and FEA specialists in Ireland to drive the testing and discussion of promising alloy candidates.

 

What has the C2C supplement enabled that you would not otherwise have been able to do?

Modern industry is multi-global and so should the training of our current and future researchers. The regulatory landscape, especially for biomedical materials and devices, is highly dependent on intercountry efforts. This tripartite partnership is creating a unique convergence of world-leading expertise from academia and industry in the fields of materials processing, surface characterization, and computational modeling with the shared goal of developing bioresorbable magnesium (Mg) alloy systems for orthopedic implant devices. We can communicate person-to-person on the different challenges associated with each country’s academic, industrial, and regulatory challenges.

In particular, the participation of Fort Wayne Metals with infrastructure in the US and Ireland serves as a real-life mentor to the research team in these areas. The international and highly interactive nature of this program empowers us to envision a unique next-generation workforce within the global knowledge economy. We plan to leverage this opportunity via student and faculty transatlantic visits and cross-institution offerings of seminars and lectures this year, as outlined in the program funding.

 

Improvement healing/treatment process for an individual and how C2C research revolutionize medical practice/treatment?

Complex orthopedic fracture fixation in pediatric, young adult and baby boomers uses a range of stable bio-inert alloys such as Ti6Al4V.  The limitations include the need for secondary surgery, especially in cases of high energy trauma in the young (traffic accidents, falls from height, sports injuries, etc.) and osteoporotic fractures in the elderly that lead to risks of inflammation and further fractures.

The C2C’s bioresobable Mg alloys of high strength, high ductility in pins, wires, rods and elastic stable intramedullary nails can provide solution as the next generation of improved devices offering significant therapeutic advantages over implants used today.

 

Who has been and/or is involved (numbers of faculty, students, etc.)

USA only: Industry members (3), Faculty (5), Students (4 G, 3UG), Clinicians (2), Scientists: (4)

 

Are there any quantifiable outputs that have been produced thus far?  We realize that it may be too early for many of the outputs to be counted at this point, but anything you have that can show the value added by the supplement would be great.

 

  • Three (3) international keynote talks and one at the NSF-CREST national meeting by Dr Sankar in which C2C program and its activities were presented emphasizing its wisdom, vision and impacts.
  • Invention disclosures have been filed at NCAT for Magnesium wire science processing
  • Joint paper published on Mg corrosion in vitro and in vivo through a collaboration between ERC researchers (UC, Pixley) and industrial members at Ft. Wayne (funded in part by C2C). Griebel, AJ, Schaffer, JE, Hopkins, TM, Alghalayini, A, Mkorombindo, T, Ojo, KO, Xu, Z, Little, KJ, Pixley, SK 2017. “An in vitro and in vivo characterization of fine WE43B magnesium wire with varied thermomechanical processing conditions”. J Biomed Mater Res Part B 2015:00B:000–000.  DOI: 10.1002/jbm.b.34008.