Degrading magnesium screws ZEK100: biomechanical testing, degradation analysis and soft-tissue biocompatibility in a rabbit model

Magnesium alloys are promising implant materials for use in orthopaedic applications. In the present study, screws made of the Mg-alloy ZEK100 (n = 12) were implanted in rabbit tibiae for four and six weeks, respectively. For degradation analysis, in vivo µ-computed tomography (µCT), a determination of the weight changes and SEM/EDX examinations of the screws were performed. Screw retention forces were verified by uniaxial pull-out tests. Additionally, soft-tissue biocompatibility was estimated using routine histological methods (H&E staining) and the immunohistological characterization of B- and T-cells. After six weeks, a 7.5% weight reduction occurred and, in dependence of the implant surrounding, the volume loss (µCT) reached 9.6% (screw head) and 5.0% for the part of the thread in the marrow cavity. Pull-out forces significantly decreased to 44.4% in comparison with the origin value directly after implantation. Soft tissue reactions were characterized by macrophage and lymphocyte infiltration, whereas T-cells as well as B-cells could be observed. In comparison to MgCa0.8-screws, the degradation rate and inflammatory tissue response were increased and the screw holding power was decreased after six weeks. In conclusion, ZEK100-screws seem to be inferior to MgCa0.8-screws, although their initial strength was more appropriate.

[1]  Frank Witte,et al.  Histology and research at the hard tissue-implant interface using Technovit 9100 New embedding technique. , 2010, Acta biomaterialia.

[2]  Alexis M Pietak,et al.  Magnesium and its alloys as orthopedic biomaterials: a review. , 2006, Biomaterials.

[3]  Andrej Atrens,et al.  Corrosion mechanism applicable to biodegradable magnesium implants , 2011 .

[4]  C. Krettek,et al.  Effect of mechanical stability on fracture healing--an update. , 2007, Injury.

[5]  Berend Denkena,et al.  Biodegradable magnesium implants for orthopedic applications , 2012, Journal of Materials Science.

[6]  Fritz Thorey,et al.  Biomechanical testing and degradation analysis of MgCa0.8 alloy screws: a comparative in vivo study in rabbits. , 2011, Acta biomaterialia.

[7]  L. Eschbach,et al.  Stainless steel in bone surgery. , 2000, Injury.

[8]  Rocky S. Tuan,et al.  What are the local and systemic biologic reactions and mediators to wear debris, and what host factors determine or modulate the biologic response to wear particles? , 2008, The Journal of the American Academy of Orthopaedic Surgeons.

[9]  Ke Yang,et al.  In vivo evaluation of biodegradable magnesium alloy bone implant in the first 6 months implantation. , 2009, Journal of biomedical materials research. Part A.

[10]  S. Goodman Wear particles, periprosthetic osteolysis and the immune system. , 2007, Biomaterials.

[11]  Ke Yang,et al.  In vivo corrosion behavior of Mg-Mn-Zn alloy for bone implant application. , 2007, Journal of biomedical materials research. Part A.

[12]  M Navarro,et al.  Biomaterials in orthopaedics , 2008, Journal of The Royal Society Interface.

[13]  Andrea Meyer-Lindenberg,et al.  Long-term in vivo degradation behaviour and biocompatibility of the magnesium alloy ZEK100 for use as a biodegradable bone implant. , 2013, Acta biomaterialia.

[14]  K. Tew,et al.  Trace elements in human physiology and pathology: zinc and metallothioneins. , 2003, Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie.

[15]  A. M. Jha,et al.  Clastogenicity of lanthanides--induction of micronuclei in root tips of Vicia faba. , 1994, Mutation research.

[16]  Yang Song,et al.  Research on an Mg-Zn alloy as a degradable biomaterial. , 2010, Acta biomaterialia.

[17]  G. O. Hofmann,et al.  Biodegradable implants in traumatology: a review on the state-of-the-art , 2004, Archives of Orthopaedic and Trauma Surgery.

[18]  G. Song,et al.  Understanding Magnesium Corrosion—A Framework for Improved Alloy Performance , 2003 .

[19]  S Ghosh,et al.  Zirconium , 1992, Biological Trace Element Research.

[20]  L. Claes,et al.  Magnitudes of local stress and strain along bony surfaces predict the course and type of fracture healing. , 1998, Journal of biomechanics.

[21]  E. Willbold,et al.  Biodegradable magnesium scaffolds: Part II: peri-implant bone remodeling. , 2007, Journal of biomedical materials research. Part A.

[22]  W. Ip,et al.  Theoretical risk assessment of magnesium alloys as degradable biomedical implants. , 2010, Acta biomaterialia.

[23]  Frank Witte,et al.  Degradable biomaterials based on magnesium corrosion , 2008 .

[24]  Frank Witte,et al.  Evaluation of short-term effects of rare earth and other elements used in magnesium alloys on primary cells and cell lines. , 2010, Acta biomaterialia.

[25]  Vangsness Ct,et al.  In vitro evaluation of the loosening characteristics of self-tapped and non-self-tapped cortical bone screws. , 1981 .

[26]  F. Beckmann,et al.  In vivo corrosion and corrosion protection of magnesium alloy LAE442. , 2010, Acta biomaterialia.

[27]  Y. Shikinami,et al.  Bioresorbable devices made of forged composites of hydroxyapatite (HA) particles and poly-L-lactide (PLLA): Part I. Basic characteristics. , 1999, Biomaterials.

[28]  Berend Denkena,et al.  In vitro corrosion of ZEK100 plates in Hank's Balanced Salt Solution , 2012, Biomedical engineering online.

[29]  Yufeng Zheng,et al.  In vitro corrosion and biocompatibility of binary magnesium alloys. , 2009, Biomaterials.

[30]  Berend Denkena,et al.  Biomechanical characterisation of a degradable magnesium-based (MgCa0.8) screw , 2012, Journal of Materials Science: Materials in Medicine.

[31]  O. Pohler,et al.  Unalloyed titanium for implants in bone surgery. , 2000, Injury.

[32]  N Birbilis,et al.  Assessing the corrosion of biodegradable magnesium implants: a critical review of current methodologies and their limitations. , 2012, Acta biomaterialia.

[33]  G. Daculsi,et al.  Cytokines, growth factors and osteoclasts. , 1998, Cytokine.

[34]  Andrea Meyer-Lindenberg,et al.  Comparison of morphological changes in efferent lymph nodes after implantation of resorbable and non-resorbable implants in rabbits , 2011, Biomedical engineering online.

[35]  Carolin Hampp,et al.  Evaluation of the biocompatibility of two magnesium alloys as degradable implant materials in comparison to titanium as non-resorbable material in the rabbit. , 2013, Materials science & engineering. C, Materials for biological applications.

[36]  Baoping Zhang,et al.  In-vitro cytotoxicity and in-vivo biocompatibility of as-extruded Mg–4.0Zn–0.2Ca alloy , 2012 .

[37]  P. Uggowitzer,et al.  MgZnCa glasses without clinically observable hydrogen evolution for biodegradable implants. , 2009, Nature materials.

[38]  M. Shive,et al.  Biodegradation and biocompatibility of PLA and PLGA microspheres , 1997 .

[39]  P. Uggowitzer,et al.  Magnesium alloys for temporary implants in osteosynthesis: in vivo studies of their degradation and interaction with bone. , 2012, Acta biomaterialia.

[40]  A. Clark,et al.  The influence of surface chemistry on implant interface histology: a theoretical basis for implant materials selection. , 1976, Journal of biomedical materials research.

[41]  Andrea Meyer-Lindenberg,et al.  Evaluation of the soft tissue biocompatibility of MgCa0.8 and surgical steel 316L in vivo: a comparative study in rabbits , 2010, Biomedical engineering online.

[42]  Henning Windhagen,et al.  Degradation behaviour and mechanical properties of magnesium implants in rabbit tibiae , 2010, Journal of Materials Science.

[43]  S. Hirano,et al.  Exposure, metabolism, and toxicity of rare earths and related compounds. , 1996, Environmental health perspectives.

[44]  K. Donath,et al.  A method for the study of undecalcified bones and teeth with attached soft tissues. The Säge-Schliff (sawing and grinding) technique. , 1982, Journal of oral pathology.

[45]  Henning Windhagen,et al.  In Vivo Corrosion of Two Novel Magnesium Alloys ZEK100 and AX30 and Their Mechanical Suitability as Biodegradable Implants , 2011, Materials.

[46]  H. Uhthoff,et al.  Mechanical factors influencing the holding power of screws in compact bone. , 1973, The Journal of bone and joint surgery. British volume.

[47]  Frank Witte,et al.  Three-dimensional microstructural analysis of Mg-Al-Zn alloys by synchrotron-radiation-based microtomography , 2008 .

[48]  Yufeng Zheng,et al.  The development of binary Mg-Ca alloys for use as biodegradable materials within bone. , 2008, Biomaterials.

[49]  H. Haferkamp,et al.  In vivo corrosion of four magnesium alloys and the associated bone response. , 2005, Biomaterials.

[50]  G. Song,et al.  Degradation of the surface appearance of magnesium and its alloys in simulated atmospheric environments , 2007 .

[51]  Henning Windhagen,et al.  In vivo assessment of the host reactions to the biodegradation of the two novel magnesium alloys ZEK100 and AX30 in an animal model , 2012, Biomedical engineering online.