Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

Windhagen, Henning; Radtke, Kerstin; Weizbauer, Andreas; Diekmann, Julia; Noll, Yvonne; Kreimeyer, Ulrike; Schavan, Robert; Stukenborg-Colsman, Christina; Waizy, Hazibullah

doi:10.1186/1475-925x-12-62

Cited by 407 publications

(265 citation statements)

References 29 publications

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“…In addition, implantation of a Mg-Y-Nd alloy containing heavy rare-earth elements into rats showed no systemic inflammatory reactions in blood smears of operated animals [34]. Thus, the findings 20 reported by others and the results shown here support the notion that Mg-based implants do not cause deleterious effects on animal growth or on inner organs.…”

Section: Discussionsupporting

confidence: 88%

“…After fracture healing, the nail usually remains but under certain circumstances such as pain or the need for another implant, removal of the intramedullary nail might become necessary [4,5]. Thus, biodegradable materials, including Mg-alloys, are promising alternatives that could obviate the need for implant removal [8,9,13,20]. Although Mgbased implants have a long history in musculoskeletal research [7], degradation, biocompatibility and the influence on bone tissue of intramedullary Mg2Ag nails under steady state and fracture conditions has not yet been investigated.…”

Section: Discussionmentioning

confidence: 99%

“…In addition to its favorable mechanical properties, Mg has been shown to increase osteoblast differentiation in vitro [18,19] and to induce new bone formation in vivo [13], demonstrating a high osteogenic potential. Furthermore, as screws for hallux valgus surgery, Mg-based implants are already in use for clinical applications [10,20]. However, these implants are much smaller than intramedullary nails and are not entirely surrounded by bone marrow, an environment that might affect implant degradation and tissue response.…”

Section: Introductionmentioning

confidence: 99%

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Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Jähn¹,

Saito

Taipaleenmäki

et al. 2016

Acta Biomaterialia

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Intramedullary stabilization is frequently used to treat long bone fractures. Implants usually remain unless complications arise. Since implant removal can become technically very challenging with the potential to cause further tissue damage, biodegradable materials are emerging as alternative options. Magnesium (Mg)-based biodegradable implants have a controllable degradation rate and good tissue compatibility, which makes them attractive for musculoskeletal research. Here we report for the first time the implantation of intramedullary nails made of an Mg alloy containing 2% silver (Mg2Ag) into intact and fractured femora of mice. Prior in vitro analyses revealed an inhibitory effect of Mg2Ag degradation products on osteoclast differentiation and function with no impair of osteoblast function. In vivo, Mg2Ag implants degraded under non-fracture and fracture conditions within 210 days and 133 days, respectively. During fracture repair, osteoblast function and subsequent bone formation were enhanced, while osteoclast activity and bone resorption were decreased, leading to an augmented callus formation. We observed a widening of the femoral shaft under steady state and regenerating conditions, which was at least in part due to an uncoupled bone remodeling. However, Mg2Ag implants did not cause any systemic adverse effects. These data suggest that Mg2Ag implants might be promising for intramedullary fixation of long bone fractures, a novel concept that has to be further investigated in future studies.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Jähn¹,

Saito

Taipaleenmäki

et al. 2016

Acta Biomaterialia

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“…12 The highest clinical knowledge was gained by using supplied or modified WE43 alloys. [13][14][15][16] Therefore this alloy was chosen as reference. The influence of cells and the in vivo environment on magnesium corrosion is not well described either.…”

Section: Introductionmentioning

confidence: 99%

In Vitro Resorption of Magnesium Materials and its Effect on Surface and Surrounding Environment

Charyeva¹

2015

MOJT

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Introduction: Magnesium has attracted much attention for its potential use in trauma and orthopedics fields due to its mechanical properties, biocompatibility, biodegradability and the possible ability to stimulate bone formation. It is desirable for magnesium-based alloys to have a low toxicity rate so the fractured bone heals before the implant resorbs. Materials and methods:Corrosion properties of Mg2Ag, Mg10Gd, WE43 and 99.99% pure Mg were studied under physiological conditions. The samples were placed in DMEM containing 10% fetal bovine serum (FBS) and corrosion was studied after immersion and by gas evolution tests. The corrosion rate (CR), osmolality, pH and Ca2¬+ concentrations, as well as surface changes in the form of average surface roughness (Sa), developed surface area ratio (Sdr) and summit density (Sds), were determined.Results: WE43 showed the highest CR of all the materials tested-1.057 mm/year, which is almost twice as high as in the other samples. The lowest mean CR was in the Mg2Ag group. All alloys made pH more alkaline and decreased the concentration of free Ca2¬+ in the solution. Osmolality decreased in all samples after day 7. Pure Mg had the most constant Sa and Sdr while WE43 had the most stable Sds of all materials over the observation period. Conclusion:The surface of alloys changed as the implants corroded: the summits became lower with time, while the pitting corrosion progressed. Mg2Ag was the most promising of all the studied materials with regard to toxicity.

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“…[ 50,51 ] Indeed, a drug-eluting, absorbable magnesium stent, and absorbable bone screws are now commercially available, and have both been the recent subjects of positive clinical human trials. [ 52,53 ] …”

Section: Magnesium As a Biomaterialsmentioning

confidence: 99%

Bulk Metallic Glasses for Implantable Medical Devices and Surgical Tools

et al. 2016

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Their inherent lack of dislocations and hence slip planes leads to exceptionally high strength and elasticity, approaching the theoretical limit. While oxide glasses and ceramics exhibit low toughness and brittle failure, BMGs can display toughness comparable to crystalline metals. [ 2 ] The lack of grain structure means that BMGs are homogeneous and exhibit isotropic behavior, even at sub-micrometer length scales, and, without grain boundaries or precipitates as oxidation sites, corrosion rates are significantly reduced compared to conventional metals.BMGs soften above an alloy-specifi c glass-transition temperature ( T g ) before eventual, time-dependent, crystallization at a higher, crystallization temperature ( T x ). In this supercooled liquid region (SCLR) between T g and T x , the viscous BMGs may be plastically shaped under low applied forces using polymer-processing techniques, such as hot embossing, extrusion, foaming, and injection and blow moulding, before again cooling to a solid metallic glass. With relatively low processing temperatures and no solidifi cation shrinkage, parts can be formed to netshape with excellent accuracy, and geometries, and surface patterns previously diffi cult in metals can be achieved with ease. [3][4][5][6][7] Such remarkable properties and behavior have led to significant interest in BMGs as engineering materials over the past 20 years, but it is only recently that their potential for use as a biomaterial has been studied. [ 8 ] To date, our understanding of material biocompatiblity has evolved mainly through empirical testing, observing the interaction of materials with cells and host tissue in vitro and in vivo. Materials can induce host responses varying from local and systemic infl ammation, hypersensistivity, toxicity, and even tumorogenesis, meaning that thorough evidence of material safety is required before regulatory approval and clinical translation. We now largely recognise the material characteristics that generate both favorable and undesired host responses, as outlined by Williams, [ 9 ] offering the opportunity for informed material design, while being cognisant that biocompatibility is specifi c to the application and host environment. [ 10 ] The original requirement of fi rst generation "biocompatible" materials was bio-inertness. [ 11 ] This included a resistance to corrosion in the body, and here Ti-and Co-based alloys scored highly. [ 12 ] Less-inert metals, such as Mg, were therefore not deemed suitable, although the ions released on dissolution are generally not harmful to the human body. However, current design requirements for biomaterials, including most recently biometals, include eliciting an appropriate host response, [ 13 ] and this can include the need to biodegrade and resorb. There are potential advantages for BMGs that span applications of With increasing knowledge of the materials science of bulk metallic glasses (BMGs) and improvements in their properties and processing, they have started to become candidate materials for biomedical dev...

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Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

Cited by 407 publications

References 29 publications

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

Intramedullary Mg2Ag nails augment callus formation during fracture healing in mice

In Vitro Resorption of Magnesium Materials and its Effect on Surface and Surrounding Environment

Bulk Metallic Glasses for Implantable Medical Devices and Surgical Tools

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