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Huang D, Koh HY, Lee BH, Bin Abd Razak HR. Radiographic and Functional Outcomes Following Resorbable Screw-Augmented Suture Fixation vs. All-Suture Fixation of Mid-pole Patellar Fractures: A Comparative Case Series. Cureus 2024; 16:e70956. [PMID: 39507140 PMCID: PMC11538046 DOI: 10.7759/cureus.70956] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 10/05/2024] [Indexed: 11/08/2024] Open
Abstract
Purpose Midpole patellar fractures are traditionally fixed with an "11-8" metal tension band construct. However, this technique is rife with implant-related complications. This study aims to evaluate the radiographic and functional outcomes following "all-suture" fixation of mid-pole patellar fractures as compared to resorbable screw-augmented suture fixation. Methods We retrospectively studied a consecutive series of 18 patients, 9 each with mid-pole patellar fractures treated with all-suture fixation or suture fixation augmented with bioabsorbable cancellous screws in our institution. The hybrid fixation cohort was significantly older (p<0.01). Radiographic and functional outcomes, such as time to union, postoperative range of motion (ROM), and the presence of complications such as fracture displacement were recorded and evaluated. The minimum follow-up was one year. Results All cases achieved radiographic union by 15 weeks postoperatively except one from the hybrid fixation cohort. The average time to radiographic union was comparable (p=0.30). Twenty-two point two percent (22.2%; 2 out of 9) of the cases from each cohort had an increase in the fracture gap (>2 mm) at around four to six weeks postoperatively, for which all except one case from the hybrid fixation cohort achieved union thereafter. One patient from the hybrid fixation cohort had fibrous non-union and further fracture displacement. There was another case of mild fracture gapping and screw breakage on review of postoperative radiographs at three months from the hybrid fixation cohort. These patients recovered without surgical revision or implant removal. Conclusions Both non-metal fixation methods for mid-pole transverse patellar fractures proved to be radiographically and functionally comparable.
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Affiliation(s)
- Daran Huang
- Orthopaedic Surgery, Sengkang General Hospital, Singapore, SGP
| | - Hun Yi Koh
- Orthopaedic Surgery, Sengkang General Hospital, Singapore, SGP
| | - Bing Howe Lee
- Orthopaedic Surgery, Sengkang General Hospital, Singapore, SGP
| | - Hamid Rahmatullah Bin Abd Razak
- Musculoskeletal Sciences, Duke-Nus Medical School, Singapore, SGP
- Orthopaedic Surgery, Sengkang General Hospital, Singapore, SGP
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2
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Franke A, Sequenc AF, Sembdner P, Seidler A, Matschke JB, Leonhardt H. Three-dimensional measurements of symmetry for the mandibular ramus. Ann Anat 2024; 253:152229. [PMID: 38367950 DOI: 10.1016/j.aanat.2024.152229] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2024] [Revised: 01/30/2024] [Accepted: 02/13/2024] [Indexed: 02/19/2024]
Abstract
BACKGROUND The study examines a sample of patients presenting for viscerocranial computer tomography that does not display any apparent signs of asymmetry, assesses the three-dimensional congruency of the mandibular ramus, and focuses on differences in age and gender. METHODS This cross-sectional cohort study screened viscerocranial CT data of patients without deformation or developmental anomalies. Segmentations were obtained from the left and right sides and superimposed according to the best-fit alignment. Comparisons were made to evaluate three-dimensional congruency and compared between subgroups according to age and gender. RESULTS Two hundred and sixty-eight patients were screened, and one hundred patients met the inclusion criteria. There were no statistical differences between the left and right sides of the mandibular ramus. Also, there were no differences between the subgroups. The overall root mean square was 0.75 ± 0.15 mm, and the mean absolute distance from the mean was 0.54 ± 0.10 mm. CONCLUSION The mean difference was less than one millimetre, far below the two-millimetre distance described in the literature that defines relative symmetry. Our study population displays a high degree of three-dimensional congruency. Our findings help to understand that there is sufficient three-dimensional congruency of the mandibular ramus, thus contributing to facilitating CAD-CAM-based procedures based on symmetry for this specific anatomic structure.
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Affiliation(s)
- Adrian Franke
- Department of Oral and Maxillofacial Surgery, University Hospital Carl Gustav Carus Dresden, Germany.
| | | | - Philipp Sembdner
- Chair of Virtual Product Development, Institute of Machine Elements and Machine Design, TU Dresden, Germany
| | - Alexander Seidler
- Chair of Virtual Product Development, Institute of Machine Elements and Machine Design, TU Dresden, Germany
| | - Jan Bernard Matschke
- Department of Oral and Maxillofacial Surgery, University Hospital Carl Gustav Carus Dresden, Germany
| | - Henry Leonhardt
- Department of Oral and Maxillofacial Surgery, University Hospital Carl Gustav Carus Dresden, Germany
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3
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Fang C, Premchand AXR, Park DH, Toon DH. Peri-articular elbow fracture fixations with magnesium implants and a review of current literature: A case series. World J Orthop 2024; 15:215-229. [PMID: 38596190 PMCID: PMC10999966 DOI: 10.5312/wjo.v15.i3.215] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2023] [Revised: 01/11/2024] [Accepted: 02/02/2024] [Indexed: 03/15/2024] Open
Abstract
BACKGROUND In recent years, the use of Magnesium alloy implants have gained renewed popularity, especially after the first commercially available Conformité Européenne approved Magnesium implant became available (MAGNEZIX® CS, Syntellix) in 2013. AIM To document our clinical and radiographical outcomes using magnesium implants in treating peri-articular elbow fractures. METHODS Our paper was based on a retrospective case series design. Intra-operatively, a standardized surgical technique was utilized for insertion of the magnesium implants. Post - operatively, clinic visits were standardized and physical exam findings, functional scores, and radiographs were obtained at each visit. All complications were recorded. RESULTS Five patients with 6 fractures were recruited (2 coronoid, 3 radial head and 1 capitellum). The mean patient age and length of follow up was 54.6 years and 11 months respectively. All fractures healed, and none exhibited loss of reduction or complications requiring revision surgery. No patient developed synovitis of the elbow joint or suffered electrolytic reactions when titanium implants were used concurrently. CONCLUSION Although there is still a paucity of literature available on the subject and further studies are required, magnesium implants appear to be a feasible tool for fixation of peri-articular elbow fractures with promising results in our series.
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Affiliation(s)
- Christopher Fang
- Department of Orthopaedic Surgery, Khoo Teck Puat Hospital, National Healthcare Group, Singapore 768828, Singapore
| | - Antony Xavier Rex Premchand
- Department of Orthopaedic Surgery, Khoo Teck Puat Hospital, National Healthcare Group, Singapore 768828, Singapore
| | - Derek Howard Park
- Department of Orthopaedic Surgery, Khoo Teck Puat Hospital, National Healthcare Group, Singapore 768828, Singapore
| | - Dong Hao Toon
- Department of Orthopaedic Surgery, Khoo Teck Puat Hospital, National Healthcare Group, Singapore 768828, Singapore
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4
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Walther M, Gottschalk O, Aurich M. Operative management of osteochondral lesions of the talus: 2024 recommendations of the working group 'clinical tissue regeneration' of the German Society of Orthopedics and Traumatology (DGOU). EFORT Open Rev 2024; 9:217-234. [PMID: 38457916 PMCID: PMC10958247 DOI: 10.1530/eor-23-0075] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/10/2024] Open
Abstract
The working group 'Clinical Tissue Regeneration' of the German Society of Orthopedics and Traumatology (DGOU) issues this paper with updating its guidelines. Literature was analyzed regarding different topics relevant to osteochondral lesions of the talus (OLT) treatment. This process concluded with a statement for each topic reflecting the best scientific evidence available with a grade of recommendation. All group members rated the statements to identify possible gaps between literature and current clinical practice. Fixation of a vital bony fragment should be considered in large fragments. In children with open physis, retrograde drilling seems to work better than in adults, but even there, the revision rate reaches 50%. The literature supports debridement with bone marrow stimulation (BMS) in lesions smaller than 1.0 cm² without bony defect. The additional use of a scaffold can be recommended in lesions larger than 1.0 cm². For other scaffolds besides AMIC®/Chondro-Gide®, there is only limited evidence. Systematic reviews report good to excellent clinical results in 87% of the patients after osteochondral transplantation (OCT), but donor site morbidity is of concern, reaching 16.9%. There is no evidence of any additional benefit from autologous chondrocyte implantation (ACI). Minced cartilage lacks any supporting data. Metallic resurfacing of OLT can only be recommended as a second-line treatment. A medial malleolar osteotomy has a minor effect on the clinical outcome compared to the many other factors influencing the clinical result.
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Affiliation(s)
- Markus Walther
- Schön Klinik München Harlaching – FIFA Medical Centre of Excellence, Harlachinger Straße, Munich, Germany
- Ludwig Maximilian University Munich, Klinik für Orthopädie und Unfallchirurgie, Muskuloskelettales Zentrum München (MUM), Marchionostraße, Munich, Germany
- Justus Maximilian University Wuerzburg, König-Ludwig-Haus, Brettreichstraße, Würzburg, Germany
- Paracelsus Medizinische Privatuniversität, Strubergasse, Salzburg, Austria
- Working Group Clinical Tissue Regeneration of the German Society of Orthopaedics and Traumatology (DGOU), Berlin, Germany
| | - Oliver Gottschalk
- Schön Klinik München Harlaching – FIFA Medical Centre of Excellence, Harlachinger Straße, Munich, Germany
- Ludwig Maximilian University Munich, Klinik für Orthopädie und Unfallchirurgie, Muskuloskelettales Zentrum München (MUM), Marchionostraße, Munich, Germany
- Working Group Clinical Tissue Regeneration of the German Society of Orthopaedics and Traumatology (DGOU), Berlin, Germany
| | - Matthias Aurich
- Working Group Clinical Tissue Regeneration of the German Society of Orthopaedics and Traumatology (DGOU), Berlin, Germany
- Martin-Luther-University Halle-Wittenberg, Universitätsklinikum Halle (Saale), DOUW - Abteilung für Unfall- und Wiederherstellungschirurgie, Ernst-Grube-Straße, Halle, Germany
- BG-Klinikum Bergmannstrost Halle, Halle, Saale, Germany
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5
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Gerengi H, Cabrini M, Solomon MM, Kaya E, Gritti L, Yola ML. Chemical, Electrochemical, and Surface Morphological Studies of the Corrosion Behavior of the AZ31 Alloy in Simulated Body Fluid: Effect of NaOH and H 2O 2 Surface Pretreatments on the Corrosion Resistance Property. ACS OMEGA 2022; 7:26687-26700. [PMID: 35936436 PMCID: PMC9352166 DOI: 10.1021/acsomega.2c02998] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/13/2022] [Accepted: 07/07/2022] [Indexed: 06/15/2023]
Abstract
Magnesium and its alloys have attracted attention for biomedical implant materials in dental and orthopedic applications because of their biodegradability and similar properties to human bones. The very high rate of degradation in the physiological systems is, however, a major setback to their utilization. Chemical modification is one of the approaches adopted to enhance the corrosion resistance property of Mg and its alloys. In this work, NaOH and H2O2 were used as a pretreatment procedure to improve the corrosion resistance of the AZ31 Mg alloy in simulated body fluid (SBF). Advanced techniques such as dynamic electrochemical impedance spectroscopy (dynamic-EIS), atomic force microscopy, and optical profilometry were used in addition to the classical mass loss, hydrogen evolution, EIS, and polarization techniques to study the corrosion resistance property of the alloy in SBF for 30 h. Results obtained show that the surface treatment significantly enhanced the corrosion resistance property of the alloy. From dynamic-EIS at 30 h, the charge transfer resistance of the untreated AZ31 Mg alloy is 432.6 Ω cm2, whereas 822.7 and 2617.3 Ω cm2 are recorded for NaOH- and H2O2-treated surfaces, respectively. H2O2 is a better treatment reagent than NaOH. The mechanism of corrosion of both untreated and treated samples in the studied corrosive medium has been discussed.
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Affiliation(s)
- Husnu Gerengi
- Corrosion
Research Laboratory, Department of Mechanical Engineering, Faculty
of Engineering, Duzce University, Duzce 81620, Turkey
- Department
of Engineering and Applied Sciences, University
of Bergamo, Dalmine, Bergamo 24044, Italy
| | - Marina Cabrini
- Department
of Engineering and Applied Sciences, University
of Bergamo, Dalmine, Bergamo 24044, Italy
| | - Moses M. Solomon
- Department
of Chemistry, College of Science and Technology, Covenant University, Ota 112104, Ogun State, Nigeria
| | - Ertugrul Kaya
- Corrosion
Research Laboratory, Department of Mechanical Engineering, Faculty
of Engineering, Duzce University, Duzce 81620, Turkey
| | - Luca Gritti
- Department
of Engineering and Applied Sciences, University
of Bergamo, Dalmine, Bergamo 24044, Italy
| | - Mehmet Lutfi Yola
- Department
of Nutrition and Dietetics, Faculty of Health Sciences, Hasan Kalyoncu University, Gaziantep 27010, Turkey
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Magnesium-Based Alloys Used in Orthopedic Surgery. MATERIALS 2022; 15:ma15031148. [PMID: 35161092 PMCID: PMC8840615 DOI: 10.3390/ma15031148] [Citation(s) in RCA: 40] [Impact Index Per Article: 13.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/18/2021] [Revised: 01/27/2022] [Accepted: 01/29/2022] [Indexed: 02/04/2023]
Abstract
Magnesium (Mg)-based alloys have become an important category of materials that is attracting more and more attention due to their high potential use as orthopedic temporary implants. These alloys are a viable alternative to nondegradable metals implants in orthopedics. In this paper, a detailed overview covering alloy development and manufacturing techniques is described. Further, important attributes for Mg-based alloys involved in orthopedic implants fabrication, physiological and toxicological effects of each alloying element, mechanical properties, osteogenesis, and angiogenesis of Mg are presented. A section detailing the main biocompatible Mg-based alloys, with examples of mechanical properties, degradation behavior, and cytotoxicity tests related to in vitro experiments, is also provided. Special attention is given to animal testing, and the clinical translation is also reviewed, focusing on the main clinical cases that were conducted under human use approval.
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Quan PH, Antoniac I, Miculescu F, Antoniac A, Păltânea VM, Robu A, Bița AI, Miculescu M, Saceleanu A, Bodog AD, Saceleanu V. Fluoride Treatment and In Vitro Corrosion Behavior of Mg-Nd-Y-Zn-Zr Alloys Type. MATERIALS 2022; 15:ma15020566. [PMID: 35057284 PMCID: PMC8779082 DOI: 10.3390/ma15020566] [Citation(s) in RCA: 11] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 12/13/2021] [Revised: 01/07/2022] [Accepted: 01/10/2022] [Indexed: 12/26/2022]
Abstract
Fluoride conversion coatings on Mg present many advantages, among which one can find the reduction of the corrosion rate under “in vivo” or “in vitro” conditions and the promotion of the calcium phosphate deposition. Moreover, the fluoride ions released from MgF2 do not present cytotoxic effects and inhibit the biofilm formation, and thus these treated alloys are very suitable for cardiovascular stents and biodegradable orthopedic implants. In this paper, the biodegradation behavior of four new magnesium biodegradable alloys that have been developed in the laboratory conditions, before and after surface modifications by fluoride conversion (and sandblasting) coatings, are analyzed. We performed structural and surface analysis (XRD, SEM, contact angle) before and after applying different surface treatments. Furthermore, we studied the electrochemical behavior and biodegradation of all experimental samples after immersion test performed in NaCl solution. For a better evaluation, we also used LM and SEM for evaluation of the corroded samples after immersion test. The results showed an improved corrosion resistance for HF treated alloy in the NaCl solution. The chemical composition, uniformity, thickness and stability of the layers generated on the surface of the alloys significantly influence their corrosion behavior. Our study reveals that HF treatment is a beneficial way to improve the biofunctional properties required for the studied magnesium alloys to be used as biomaterials for manufacturing the orthopedic implants.
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Affiliation(s)
- Pham Hong Quan
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Iulian Antoniac
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
- Academy of Romania Scientist, 54 Splaiul Independentei, 050094 Bucharest, Romania
| | - Florin Miculescu
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Aurora Antoniac
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Veronica Manescu Păltânea
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
- Faculty of Electrical Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Alina Robu
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Ana-Iulia Bița
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Marian Miculescu
- Faculty of Material Science and Engineering, University Politehnica of Bucharest, 313 Splaiul Independentei, District 6, 060042 Bucharest, Romania
| | - Adriana Saceleanu
- Faculty of Medicine, Lucian Blaga University of Sibiu, 2A Lucian Blaga Street, 550169 Sibiu, Romania
| | - Alin Dănuț Bodog
- Faculty of Medicine and Pharmacy, University of Oradea, 10 P-ta 1 December Street, 410073 Oradea, Romania
| | - Vicentiu Saceleanu
- Faculty of Medicine, Lucian Blaga University of Sibiu, 2A Lucian Blaga Street, 550169 Sibiu, Romania
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8
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Leigheb M, Veneziano M, Tortia R, Bosetti M, Cochis A, Rimondini L, Grassi FA. Osteosynthesis devices in absorbable Magnesium alloy in comparison to standard ones: a Systematic Review on effectiveness and safety. ACTA BIO-MEDICA : ATENEI PARMENSIS 2021; 92:e2021025. [PMID: 34313658 PMCID: PMC8420826 DOI: 10.23750/abm.v92is3.11757] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/07/2021] [Accepted: 06/21/2021] [Indexed: 11/23/2022]
Abstract
BACKGROUND AND AIM OF THE WORK Magnesium (Mg) is a metal physiologically present in bone tissue and essential for bone health. Mg-based-alloys exhibit mechanical properties, namely density and strength, similar to human cortical bone. These features have been exploited for the development of osteosynthesis devices in biodegradable Mg-based-alloys. Accordingly, the aim of this study was to rank the effectiveness and safety of Mg-based alloys applied in bone surgery in comparison to other suitable metals, focusing in particular on Mg superior biocompatibility and biodegradability. METHODS a systematic-review of the literature was conducted including only primary research studies dealing with patients suffering from fractured or osteotomized bones fixed using Mg-based osteosynthesis-devices. RESULTS literature revision suggested Mg-alloys holding comparable properties and side effects in comparison with titanium (Ti) screws, thus showing similar efficacy and safety. In particular, the gas formation in the carpal bones was identified as the main side effect of the Mg-alloys, during the corrosion/degradation phase of Mg. CONCLUSIONS according to the considered literature, the main advantages exploiting Mg-alloys for bone implants are related to their biocompatibility, bio-absorbability/-degradability, the lack of surgical removal, osteoconductivity and antibacterial activity. On the opposite, the main limitation of Mg-alloys is due to the poor mechanical resistance of small devices for internal fixation of bone fragments that lack of sufficient strength to withstand high forces. Therefore, an important future prospect could rely in the development of innovative hybrid systems aimed at fixing high load-bearing fractures, as well as in regenerative-medicine by developing new Mg-based engineered scaffolds.
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Affiliation(s)
- Massimiliano Leigheb
- Orthopaedics and Traumatology, A.O.U. "Maggiore d.c."Universiy of Eastern Piedmont, Novara.
| | - Michela Veneziano
- Department of Orthopaedics and Traumatology, "Maggiore della Carità" Hospital, Novara, Italy.
| | - Rosalba Tortia
- Department of Health Sciences, Università del Piemonte Orientale (UPO), Novara, Italy.
| | - Michela Bosetti
- Department of "Scienze del Farmaco", Università del Piemonte Orientale (UPO), Novara, Italy.
| | - Andrea Cochis
- Department of Health Sciences, Center for Translational Research on Autoimmune and Allergic Diseases-CAAD, Università del Piemonte Orientale (UPO), Novara, Italy.
| | - Lia Rimondini
- Department of Health Sciences, Center for Translational Research on Autoimmune and Allergic Diseases-CAAD, Università del Piemonte Orientale (UPO), Novara, Italy.
| | - Federico Alberto Grassi
- Department of Orthopaedics and Traumatology, "Maggiore della Carità" Hospital, Novara, Italy; Department of Health Sciences, Università del Piemonte Orientale (UPO), Novara, Italy.
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9
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Abstract
Magnesium is a promising material. It has a remarkable mix of mechanical and biomedical properties that has made it suitable for a vast range of applications. Moreover, with alloying, many of these inherent properties can be further improved. Today, it is primarily used in the automotive, aerospace, and medical industries. However, magnesium has its own set of drawbacks that the industry and research communities are actively addressing. Magnesium’s rapid corrosion is its most significant drawback, and it dramatically impeded magnesium’s growth and expansion into other applications. This article reviews both the engineering and biomedical aspects and applications for magnesium and its alloys. It will also elaborate on the challenges that the material faces and how they can be overcome and discuss its outlook.
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Baldini M, Coppa V, Falcioni D, Senigagliesi E, Marinelli M, Gigante AP. Use of resorbable magnesium screws in children: systematic review of the literature and short-term follow-up from our series. J Child Orthop 2021; 15:194-203. [PMID: 34211595 PMCID: PMC8223084 DOI: 10.1302/1863-2548.15.210004] [Citation(s) in RCA: 14] [Impact Index Per Article: 3.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/08/2021] [Accepted: 04/06/2021] [Indexed: 02/03/2023] Open
Abstract
PURPOSE Biodegradable implants are of major interest in orthopaedics, especially in the skeletally immature population. Magnesium (Mg) implants are promising for selected surgical procedure in adults, but evidence is lacking. Thus, the aim of this study is to analyze the safety and efficacy of resorbable Mg screw in different orthopaedic procedures in skeletally immature patients. In addition, we present a systematic review of the current literature on the clinical use of Mg implants. METHODS From 2018 until the writing of this manuscript, consecutive orthopaedic surgical procedures involving the use of Mg screws performed at our centre in patients < 15 years of age were retrospectively reviewed. In addition, a systematic review of the literature was performed in the main databases. We included clinical studies conducted on humans, using Mg-alloy implants for orthopaedic procedures. RESULTS A total of 14 patients were included in this retrospective analysis. Mean age at surgery was 10.8 years (sd 2.4), mean follow-up was 13.8 months (sd 7.5). Healing was achieved in all the procedures, with no implant-related adverse reaction. No patients required any second surgical procedure. The systematic review evidenced 20 clinical studies, 19 of which conducted on an adult and one including paediatric patients. CONCLUSION Evidence on resorbable Mg implants is low but promising in adults and nearly absent in children. Our series included apophyseal avulsion, epiphyseal fractures, osteochondritis dissecans, displaced osteochondral fragment and tendon-to-bone fixation. Mg screws guaranteed stable fixation, without implant failure, with good clinical and radiological results and no adverse events. LEVEL OF EVIDENCE IV - Single cohort retrospective analysis with systematic review.
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Affiliation(s)
- Marco Baldini
- Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, Ancona, Italy
| | - Valentino Coppa
- Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, Ancona, Italy
| | - Danya Falcioni
- Clinic of Adult and Paediatric Orthopedic, Azienda Ospedal-iero-Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy
| | - Elisa Senigagliesi
- Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, Ancona, Italy
| | - Mario Marinelli
- Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, Ancona, Italy
| | - Antonio Pompilio Gigante
- Clinical Orthopedics, Department of Clinical and Molecular Science, School of Medicine, Università Politecnica delle Marche, Ancona, Italy
- Clinic of Adult and Paediatric Orthopedic, Azienda Ospedal-iero-Universitaria, Ospedali Riuniti di Ancona, Ancona, Italy
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11
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Kandala BSPK, Zhang G, LCorriveau C, Paquin M, Chagnon M, Begun D, Shanov V. Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents. Bioact Mater 2021; 6:1663-1675. [PMID: 33313446 PMCID: PMC7708697 DOI: 10.1016/j.bioactmat.2020.11.012] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/03/2020] [Revised: 11/11/2020] [Accepted: 11/11/2020] [Indexed: 02/06/2023] Open
Abstract
Magnesium metal (Mg) is a promising material for stent applications due to its biocompatibility and ability to be resorbed by the body. Manufacturing of stents by laser cutting has become an industry standard. Our alternative approach uses photo-chemical etching to transfer a pattern of the stent onto a Mg sheet. In this study, we present three stages of creating and validating a stent prototype, which includes design and simulation using finite element analysis (FEA), followed by fabrication based on AZ31 alloy and, finally, in vivo testing in peripheral arteries of domestic pigs. Due to the preliminary character of this study, only six stents were implanted in two domestic farm pigs weighing 25-28 kg and they were evaluated after 28 days, with an interim follow-up on day 14. The left and right superficial femoral, the left iliac, and the right renal artery were selected for this study. The diameters of the stented artery segments were evaluated at the time of implantation, on day 14 and then, finally, on day 28, by quantitative vessel analysis (QVA) using fluoroscopic imaging. Optical Coherence Tomography (OCT) imaging displayed some malposition, breaks, stacking, and protrusion into the lumen at the proximal, distal, and mid-sections of the stented arteries. The stents degraded with time, but simultaneously became embedded in the intima. After 28 days, the animals were euthanized, and explanted vessels were fixed for micro-CT imaging and histology studies. Micro-CT imaging revealed stent morphological and volumetric changes due to the in-body degradation. An in vivo corrosion rate of 0.75 mm/year was obtained by the CT evaluation. The histology suggested no-life threatening effects, although moderate injury, inflammation, and endothelialization scores were observed.
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Affiliation(s)
| | - Guangqi Zhang
- Department of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USA
| | - Capucine LCorriveau
- Charles River Laboratories Montreal ULC, Boisbriand, Quebec, J7H 1N8, Canada
| | - Mark Paquin
- Medical Products Market Consulting, Inc, Indianapolis, IN, 46202, USA
| | - Madeleine Chagnon
- Charles River Laboratories Montreal ULC, Boisbriand, Quebec, J7H 1N8, Canada
| | - Dana Begun
- Waygate Technologies, Baker Hughes, Cincinnati, OH, 45241, USA
| | - Vesselin Shanov
- Department of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USA
- Department of Chemical and Environmental Engineering, University of Cincinnati, OH, 45221, USA
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12
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Research status of biodegradable metals designed for oral and maxillofacial applications: A review. Bioact Mater 2021; 6:4186-4208. [PMID: 33997502 PMCID: PMC8099919 DOI: 10.1016/j.bioactmat.2021.01.011] [Citation(s) in RCA: 33] [Impact Index Per Article: 8.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/24/2020] [Revised: 01/10/2021] [Accepted: 01/10/2021] [Indexed: 01/08/2023] Open
Abstract
The oral and maxillofacial regions have complex anatomical structures and different tissue types, which have vital health and aesthetic functions. Biodegradable metals (BMs) is a promising bioactive materials to treat oral and maxillofacial diseases. This review summarizes the research status and future research directions of BMs for oral and maxillofacial applications. Mg-based BMs and Zn-based BMs for bone fracture fixation systems, and guided bone regeneration (GBR) membranes, are discussed in detail. Zn-based BMs with a moderate degradation rate and superior mechanical properties for GBR membranes show great potential for clinical translation. Fe-based BMs have a relatively low degradation rate and insoluble degradation products, which greatly limit their application and clinical translation. Furthermore, we proposed potential future research directions for BMs in the oral and maxillofacial regions, including 3D printed BM bone scaffolds, surface modification for BMs GBR membranes, and BMs containing hydrogels for cartilage regeneration, soft tissue regeneration, and nerve regeneration. Taken together, the progress made in the development of BMs in oral and maxillofacial regions has laid a foundation for further clinical translation.
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Herber V, Okutan B, Antonoglou G, Sommer NG, Payer M. Bioresorbable Magnesium-Based Alloys as Novel Biomaterials in Oral Bone Regeneration: General Review and Clinical Perspectives. J Clin Med 2021; 10:jcm10091842. [PMID: 33922759 PMCID: PMC8123017 DOI: 10.3390/jcm10091842] [Citation(s) in RCA: 20] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/29/2021] [Revised: 04/15/2021] [Accepted: 04/19/2021] [Indexed: 02/07/2023] Open
Abstract
Bone preservation and primary regeneration is a daily challenge in the field of dental medicine. In recent years, bioresorbable metals based on magnesium (Mg) have been widely investigated due to their bone-like modulus of elasticity, their high biocompatibility, antimicrobial, and osteoconductive properties. Synthetic Mg-based biomaterials are promising candidates for bone regeneration in comparison with other currently available pure synthetic materials. Different alloys based on Mg were developed to fit clinical requirements. In parallel, advances in additive manufacturing offer the possibility to fabricate experimentally bioresorbable metallic porous scaffolds. This review describes the promising clinical results of resorbable Mg-based biomaterials for bone repair in osteosynthetic application and discusses the perspectives of use in oral bone regeneration.
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Affiliation(s)
- Valentin Herber
- Department of Dentistry and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010 Graz, Austria; (G.A.); (M.P.)
- Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6, 8036 Graz, Austria; (B.O.); (N.G.S.)
- Correspondence:
| | - Begüm Okutan
- Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6, 8036 Graz, Austria; (B.O.); (N.G.S.)
| | - Georgios Antonoglou
- Department of Dentistry and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010 Graz, Austria; (G.A.); (M.P.)
| | - Nicole G. Sommer
- Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6, 8036 Graz, Austria; (B.O.); (N.G.S.)
| | - Michael Payer
- Department of Dentistry and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010 Graz, Austria; (G.A.); (M.P.)
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Crozier-Shaw G, Mahon J, Bayer TC. The use of bioabsorbable compression screws & polyethylene tension band for fixation of displaced olecranon fractures. J Orthop 2020; 22:525-529. [PMID: 33132626 PMCID: PMC7588653 DOI: 10.1016/j.jor.2020.08.029] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/15/2020] [Revised: 08/03/2020] [Accepted: 08/26/2020] [Indexed: 11/16/2022] Open
Abstract
INTRODUCTION Transverse fractures of the olecranon are commonly fixed using tension-band wiring techniques. However the superficial nature of this area leads to high complication rates requiring removal of metalwork. The purpose of this retrospective study is to report and evaluate functional outcomes of polyethylene tension-band and bioabsorbable Magnesium alloy screw fixation of olecranon fractures. METHODS A retrospective case-control study was undertaken. Demographics, injury type and post-operative details were collected. All patients were treated in the same institution by a single surgeon. Primary outcomes included radiographic healing and post-operative range of motion. Secondary outcome was post-operative complications. RESULTS A total of five cases were identified. Mean age was 52.4. The control group was made up of six patients treated with a traditional tension band wire fixation. One patient in study group was lost to follow up. 80% of fractures in study group demonstrated anatomic post-operative radiographic union, compared with 83% of control group. All patients had range of motion above 100°, with full protonation and supination. One patient did have an extension lag of 15°. CONCLUSION Surgical repair of olecranon fractures is often complicated by the need for re-operation. This method provides both intramedullary fixation and conversion of distraction forces to compression forces with bioabsorbable materials, and aims to reduce the high re-operation rates commonly seen by avoiding the use of permanent indwelling metal hardware.
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Affiliation(s)
- Geoff Crozier-Shaw
- Department of Trauma and Orthopaedic Surgery, Midland Regional Hospital Tullamore, Co Offaly, Ireland
| | - John Mahon
- Department of Trauma and Orthopaedic Surgery, Midland Regional Hospital Tullamore, Co Offaly, Ireland
| | - Thomas C. Bayer
- Department of Trauma and Orthopaedic Surgery, Midland Regional Hospital Tullamore, Co Offaly, Ireland
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Lin J, Nguyen NYT, Zhang C, Ha A, Liu HH. Antimicrobial Properties of MgO Nanostructures on Magnesium Substrates. ACS OMEGA 2020; 5:24613-24627. [PMID: 33015479 PMCID: PMC7528336 DOI: 10.1021/acsomega.0c03151] [Citation(s) in RCA: 20] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 06/30/2020] [Accepted: 08/25/2020] [Indexed: 05/19/2023]
Abstract
Magnesium (Mg) and its alloys have attracted increasing attention in recent years as medical implants for repairing musculoskeletal injuries because of their promising mechanical and biological properties. However, rapid degradation of Mg and its alloys in physiological fluids limited their clinical translation because the accumulation of hydrogen (H2) gas and fast release of OH- ions could adversely affect the healing process. Moreover, infection is a major concern for internally implanted devices because it could lead to biofilm formation, prevent host cell attachment on the implants, and interfere osseointegration, resulting in implant failure or other complications. Fabricating nanostructured magnesium oxide (MgO) on magnesium (Mg) substrates is promising in addressing both problems because it could slow down the degradation process and improve the antimicrobial activity. In this study, nanostructured MgO layers were created on Mg substrates using two different surface treatment techniques, i.e., anodization and electrophoretic deposition (EPD), and cultured with Staphylococcus aureus in vitro to determine their antimicrobial properties. At the end of the 24-h bacterial culture, the nanostructured MgO layers on Mg prepared by anodization or EPD both showed significant bactericidal effect against S. aureus. Thus, nanostructured MgO layers on Mg are promising for reducing implant-related infections and complications and should be further explored for clinical translation toward antimicrobial biodegradable implants.
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Affiliation(s)
- Jiajia Lin
- Material
Science & Engineering Program, University
of California, Riverside, 900 University Avenue, Riverside, California 92521, United States
| | - Nhu-Y Thi Nguyen
- Microbiology
Program, University of California, Riverside, 900 University Avenue, Riverside, California 92521, United States
| | - Chaoxing Zhang
- Material
Science & Engineering Program, University
of California, Riverside, 900 University Avenue, Riverside, California 92521, United States
| | - Alexandra Ha
- Department
of Bioengineering, University of California,
Riverside, 900 University
Avenue, Riverside, California 92521, United States
| | - Huinan Hannah Liu
- Material
Science & Engineering Program, University
of California, Riverside, 900 University Avenue, Riverside, California 92521, United States
- Microbiology
Program, University of California, Riverside, 900 University Avenue, Riverside, California 92521, United States
- Department
of Bioengineering, University of California,
Riverside, 900 University
Avenue, Riverside, California 92521, United States
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Holweg P, Berger L, Cihova M, Donohue N, Clement B, Schwarze U, Sommer NG, Hohenberger G, van den Beucken JJ, Seibert F, Leithner A, Löffler JF, Weinberg AM. A lean magnesium-zinc-calcium alloy ZX00 used for bone fracture stabilization in a large growing-animal model. Acta Biomater 2020; 113:646-659. [PMID: 32553919 DOI: 10.1016/j.actbio.2020.06.013] [Citation(s) in RCA: 25] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/02/2020] [Revised: 06/04/2020] [Accepted: 06/09/2020] [Indexed: 12/15/2022]
Abstract
Over the last decade, demand has increased for developing new, alternative materials in pediatric trauma care to overcome the disadvantages associated with conventional implant materials. Magnesium (Mg)-based alloys seem to adequately fulfill the vision of a homogeneously resorbable, biocompatible, load-bearing and functionally supportive implant. The aim of the present study is to introduce the high-strength, lean alloy Mg‒0.45Zn‒0.45Ca, in wt% (ZX00), and for the first time investigate the clinical applicability of screw osteosynthesis using this alloy that contains no rare-earth elements. The alloy was applied in a growing sheep model with osteotomized bone (simulating a fracture) and compared to a non-osteotomy control group regarding degradation behavior and fracture healing. The alloy exhibits an ultimate tensile strength of 285.7 ± 3.1 MPa, an elongation at fracture of 18.2 ± 2.1%, and a reduced in vitro degradation rate compared to alloys containing higher amounts of Zn. In vivo, no significant difference between the osteotomized bone and the control group was found regarding the change in screw volume over implantation time. Therefore, it can be concluded that the fracture healing process, including its effects on the surrounding area, has no significant influence on degradation behavior. There was also no negative influence from hydrogen-gas formation on fracture healing. Despite the proximal and distal screws showing chronologically different gas release, the osteotomy showed complete consolidation. STATEMENT OF SIGNIFICANCE: Conventional implants involve several disadvantages in pediatric trauma care. Magnesium-based alloys seem to overcome these issues as discussed in the recent literature. This study evaluates the clinical applicability of high-strength lean Mg‒0.45Zn‒0.45Ca (ZX00) screws in a growing-sheep model. Two groups, one including a simulated fracture and one group without fracture, underwent implantation of the alloy and were compared to each other. No significant difference regarding screw volume was observed between the groups. There was no negative influence of hydrogen-gas formation on fracture healing and a complete fracture consolidation was found after 12 weeks for all animals investigated.
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Holweg P, Herber V, Ornig M, Hohenberger G, Donohue N, Puchwein P, Leithner A, Seibert F. A lean bioabsorbable magnesium-zinc-calcium alloy ZX00 used for operative treatment of medial malleolus fractures: early clinical results of a prospective non-randomized first in man study. Bone Joint Res 2020; 9:477-483. [PMID: 32874554 PMCID: PMC7437522 DOI: 10.1302/2046-3758.98.bjr-2020-0017.r2] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/07/2023] Open
Abstract
Aims This study is a prospective, non-randomized trial for the treatment of fractures of the medial malleolus using lean, bioabsorbable, rare-earth element (REE)-free, magnesium (Mg)-based biodegradable screws in the adult skeleton. Methods A total of 20 patients with isolated, bimalleolar, or trimalleolar ankle fractures were recruited between July 2018 and October 2019. Fracture reduction was achieved through bioabsorbable Mg-based screws composed of pure Mg alloyed with zinc (Zn) and calcium (Ca) ( Mg-Zn0.45-Ca0.45, in wt.%; ZX00). Visual analogue scale (VAS) and the presence of complications (adverse events) during follow-up (12 weeks) were used to evaluate the clinical outcomes. The functional outcomes were analyzed through the range of motion (ROM) of the ankle joint and the American Orthopaedic Foot and Ankle Society (AOFAS) score. Fracture reduction and gas formation were assessed using several plane radiographs. Results The follow-up was performed after at least 12 weeks. The mean difference in ROM of the talocrural joint between the treated and the non-treated sites decreased from 39° (SD 12°) after two weeks to 8° (SD 11°) after 12 weeks (p ≤ 0.05). After 12 weeks, the mean AOFAS score was 92.5 points (SD 4.1). Blood analysis revealed that Mg and Ca were within a physiologically normal range. All ankle fractures were reduced and stabilized sufficiently by two Mg screws. A complete consolidation of all fractures was achieved. No loosening or breakage of screws was observed. Conclusion This first prospective clinical investigation of fracture reduction and fixation using lean, bioabsorbable, REE-free ZX00 screws showed excellent clinical and functional outcomes. Cite this article: Bone Joint Res 2020;9(8):477–483.
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Affiliation(s)
- Patrick Holweg
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Valentin Herber
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Martin Ornig
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Gloria Hohenberger
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Nicolas Donohue
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Paul Puchwein
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Andreas Leithner
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
| | - Franz Seibert
- Department of Orthopaedics and Trauma, Medical University of Graz, Graz, Austria
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Campos Becerra LH, Hernández Rodríguez MAL, Esquivel Solís H, Lesso Arroyo R, Torres Castro A. Bio-inspired biomaterial Mg-Zn-Ca: a review of the main mechanical and biological properties of Mg-based alloys. Biomed Phys Eng Express 2020; 6:042001. [PMID: 33444260 DOI: 10.1088/2057-1976/ab9426] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
Abstract
The toxicity of alloying elements in magnesium alloys used for biomedical purposes is an interesting and innovative subject, due to the great technological advances that would result from their application in medical devices (MDs) in traumatology. Recently promising results have been published regarding the rates of degradation and mechanical integrity that can support Mg alloys; this has led to an interest in understanding the toxicological features of these emerging biomaterials. The growing interest of different segments of the MD market has increased the determination of different research groups to clarify the behavior of alloying elements in vivo. This review covers the influence of the alloying elements on the body, the toxicity of the elements in Mg-Zn-Ca, as well as the mechanical properties, degradation, processes of obtaining the alloy, medical approaches and future perspectives on the use of the Mg in the manufacture of MDs for various medical applications.
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Affiliation(s)
- Luis Humberto Campos Becerra
- Facultad de Ingeniería Mecánica y Eléctrica., Biomateriales. Universidad Autónoma de Nuevo León (UANL), Pedro de Alba S/N, Ciudad Universitaria, San Nicolás de los Garza, México
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Bioabsorbable magnesium screw versus conventional titanium screw fixation for medial malleolar fractures. J Orthop Traumatol 2020; 21:9. [PMID: 32451727 PMCID: PMC7248135 DOI: 10.1186/s10195-020-00547-7] [Citation(s) in RCA: 36] [Impact Index Per Article: 7.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/07/2020] [Accepted: 04/24/2020] [Indexed: 12/21/2022] Open
Abstract
Background It is still unknown whether bioabsorbable magnesium (Mg) screws provide an advantage over titanium screws in the treatment of medial malleolar (MM) fractures. The purpose of this retrospective study is to compare the clinical and radiological outcomes of MM fractures fixed with either bioabsorbable Mg screws or conventional titanium screws. Materials and methods A cohort of 48 patients with MM fractures who underwent compression screw fixation was retrospectively reviewed. Twenty-three patients (16 male, 7 female; mean age: 37.9 ± 17.7 years) were treated with bioabsorbable Mg screws, and 25 patients (14 male, 11 female; mean age: 45.0 ± 15.7 years) were treated with conventional titanium screw fixation. All patients were followed up for at least 1 year, with a mean time of 24.6 ± 10.5 months (12–53 months). The American Orthopedic Foot and Ankle Society (AOFAS) scale was used to evaluate the clinical results. The Kellgren–Lawrence (KL) osteoarthritis grading was used to evaluate posttraumatic osteoarthritis on final ankle radiographs. Fracture union, rate of implant removal, and complications were recorded. Comparative analysis of two independent groups was performed using the chi-squared test and the Mann–Whitney U-test. Results The two groups were comparable concerning demographic and clinical characteristics. Age (p = 0.146), sex (p = 0.252), side (p = 0.190), MM fracture type (p = 0.500), associated fractures (p = 0.470), and follow-up period (p = 0.903) were similar between the groups. At final follow-up examination, AOFAS score (p = 0.191) was similar between groups. Fracture union was achieved in all cases. Grade of posttraumatic osteoarthritis, according to KL, was equally distributed in both groups (p = 0.074). No deep infection or osteomyelitis was seen. Five patients in the titanium screw group underwent implant removal, due to pain in three of them and difficulty in wearing shoes in the other two (p = 0.031). Implant removal was performed after a mean of 14.2 ± 3.1 months (12–19 months). Conclusions Bioabsorbable Mg and titanium screws had similar therapeutic efficacy in MM fracture fixation regarding functional and radiological outcomes. However, the rate of implant removal was higher with titanium screws. Bioabsorbable Mg screws may be a favorable fixation option since secondary implant removal procedures can be prevented. Level of evidence Level IV, Retrospective case series.
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Kim YK, Kim SY, Lee SH, Lee MH, Lee KB. Stabilized Loading of Hyaluronic Acid-Containing Hydrogels into Magnesium-Based Cannulated Screws. ACS Biomater Sci Eng 2019; 6:715-726. [PMID: 33463217 DOI: 10.1021/acsbiomaterials.9b01057] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/29/2022]
Abstract
Cannulated screws have a structure for inserting a guide wire inside them to effectively correct complicated fractures. Magnesium, an absorbable metal used to manufacture cannulated screws, may decompose in the body after a certain period of implantation. The hydrogel formed by hyaluronic acid (HA) and polygalacturonic acid (PGA) has been used into Mg-based cannulated screws to prevent bone resorption owing to the rapid corrosion of Mg with unfavorable mechanical properties and a high ambient pH. In addition, Ca ions were added to the gel for cross-linking the carboxyl groups to modify the gelation rate and physical properties of the gel. The developed hydrogels were injected into the Mg-based cannulated screws, after which they released HA and Ca. The possibility of the application of this system as a cannulated screw was evaluated based on the corrosion resistance, gel degradation rate, HA release, toxicity toward osteocytes, and experiments involving the implantation of the screws into the femurs of rats. Ca ions first bound to PGA and delayed the gelation time and dissolution rate. However, they interfered with HA binding and increased the elution of HA at the beginning of gel degradation. Ca(NO3)2 concentrations higher than 0.01 M and low pH environments inhibited osteoblast differentiation and proliferation, owing to the elution of HA from the hydrogel. On the other hand, when the HA hydrogel with a proper amount of Ca was inserted into a magnesium screw, the degradation of Mg was delayed, and the presence of the gel contributed to new bone formation and osteocyte expansion.
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Affiliation(s)
- Yu-Kyoung Kim
- Department of Dental Biomaterials and Institute of Biodegradable Materials, Institute of Oral Bioscience and School of Dentistry (Plus BK21 Program), Chonbuk National University, Jeon Ju 561-756, South Korea
| | - Seo-Young Kim
- Department of Dental Biomaterials and Institute of Biodegradable Materials, Institute of Oral Bioscience and School of Dentistry (Plus BK21 Program), Chonbuk National University, Jeon Ju 561-756, South Korea
| | - Se Hwan Lee
- Department of Orthopedic Surgery, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Chonbuk National University Medical School, Jeon Ju 561-756, South Korea
| | - Min-Ho Lee
- Department of Dental Biomaterials and Institute of Biodegradable Materials, Institute of Oral Bioscience and School of Dentistry (Plus BK21 Program), Chonbuk National University, Jeon Ju 561-756, South Korea
| | - Kwang-Bok Lee
- Department of Orthopedic Surgery, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Chonbuk National University Medical School, Jeon Ju 561-756, South Korea
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Soderlind J, Cihova M, Schäublin R, Risbud S, Löffler JF. Towards refining microstructures of biodegradable magnesium alloy WE43 by spark plasma sintering. Acta Biomater 2019; 98:67-80. [PMID: 31254685 DOI: 10.1016/j.actbio.2019.06.045] [Citation(s) in RCA: 25] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/14/2018] [Revised: 06/19/2019] [Accepted: 06/24/2019] [Indexed: 11/29/2022]
Abstract
Microstructural refinement of magnesium (Mg) alloys is beneficial for mechanical and corrosion properties, both of which are critical for their successful application as temporary implant materials. One method of achieving a refined microstructure is through rapid solidification via gas-atomization-powder production. In this study we investigated spark plasma sintering (SPS) as a potential processing method for maintaining this refined microstructure while achieving a range of porosities up to full densification. We characterized the microstructural evolution as a function of sintering temperature from 250 to 450 °C for the alloy WE43 using multi-scale correlative microscopy techniques, including light microscopy and scanning and transmission electron microscopy-based methods. The spatial distribution of the two major alloying elements, neodymium (Nd) and yttrium (Y), was determined and the intermetallic phases they form identified using energy dispersive X-ray spectroscopy in conjunction with electron diffraction. The gas-atomized powder microstructure consists of Mg-rich dendrites and a percolating interdendritic Mg-Nd-Y ternary phase with structure Mg14Nd2Y, surrounded by a high Nd and Y content in solid solution. This microstructure is maintained up to a sintering temperature of 350 °C, while with higher sintering temperatures segregation of Nd and Y dominates. The percolating ternary phase breaks up into faceted globular precipitates with structure Mg5Nd, which is isomorphous to Mg14Nd2Y. Y comes out of solution and migrates to previous powder-particle surfaces, possibly forming Y2O3. Sample densities ranged from 64 to 100% for sintering temperatures of 250 to 450 °C, respectively, and the grain size remained constant at about 10 µm. SPS is demonstrated to be an attractive alternative method for processing Mg alloys to a wide range of porosities and fine microstructures. The microstructural refinement achieved by SPS holds the potential for slow and homogeneous corrosion. STATEMENT OF SIGNIFICANCE: This study presents the impact spark plasma sintering (SPS) has on the microstructure of WE43, a magnesium alloy used for biodegradable implants. SPS is of great interest in this context as it is scalable, rapid, and has the potential for tuning density while maintaining a refined microstructure. The microstructure and density are explored from the gas-atomized powder to the densified material using electron microscopy and chemical mapping from the macro- to the nano-level. The insights gained reveal an original evolution of rare-earth element distribution with an isomorphous chemistry change, while the microstructure develops from the non-equilibrium state (powder) towards an equilibrium structure upon sintering. This study, including measurements of mechanical performance, sets the premises of SPS for the fabrication of Mg-based implants with tunable characteristics.
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Affiliation(s)
- Julie Soderlind
- Department of Materials Science and Engineering, University of California, Davis, CA 95616, United States; Lawrence Livermore National Laboratory, Livermore, CA 94550, United States; Laboratory of Metal Physics and Technology, Department of Materials, ETH Zurich, 8093 Zurich, Switzerland
| | - Martina Cihova
- Laboratory of Metal Physics and Technology, Department of Materials, ETH Zurich, 8093 Zurich, Switzerland
| | - Robin Schäublin
- Laboratory of Metal Physics and Technology, Department of Materials, ETH Zurich, 8093 Zurich, Switzerland
| | - Subhash Risbud
- Department of Materials Science and Engineering, University of California, Davis, CA 95616, United States
| | - Jörg F Löffler
- Laboratory of Metal Physics and Technology, Department of Materials, ETH Zurich, 8093 Zurich, Switzerland.
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Könneker S, Krockenberger K, Pieh C, von Falck C, Brandewiede B, Vogt PM, Kirschner MH, Ziegler A. Comparison of SCAphoid fracture osteosynthesis by MAGnesium-based headless Herbert screws with titanium Herbert screws: protocol for the randomized controlled SCAMAG clinical trial. BMC Musculoskelet Disord 2019; 20:357. [PMID: 31387574 PMCID: PMC6685162 DOI: 10.1186/s12891-019-2723-9] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/23/2019] [Accepted: 06/26/2019] [Indexed: 11/10/2022] Open
Abstract
Background Scaphoid fractures are the most common carpal fractures. They often need to be treated by surgery, where the use of a compression screw is the globally accepted gold standard. Surgeons may choose between different implant materials including titanium alloys, which remain in the body or are removed after healing. An alternative are biodegradable magnesium-based implants. Properties of magnesium alloys include high stability, osteoconductivity, potential reduction of infections and few artifacts in magnetic resonance imaging (MRI). The aim of this trial is to demonstrate non-inferiority of magnesium-based compression screws compared with titanium Herbert screws for scaphoid fractures. Methods The trial is designed as a multicenter, blinded observer, randomized controlled parallel two-group post market trial. Approximately 190 patients will be randomized (1:1) with stratification by center either to titanium or magnesium-based compression screws. Follow-up is 1 year per patient. Surgical procedures and aftercare will be performed according to the German treatment guideline for scaphoid fractures. The first primary endpoint is the patient-rated wrist evaluation (PRWE) score after 6 months. The second primary endpoint is a composite safety endpoint including bone union until 6 months, no adverse device effect (ADE) during surgery or wound healing and no serious ADE or reoperation within 1 year. The third primary endpoint is the difference in change MRI artifacts over time. Non-inferiority will be investigated for primary endpoints 1 (t-test confidence interval) and 2 (Wilson’s score interval) using both the full analysis set (FAS) and the per protocol population at the one-sided 2.5% test-level. Superiority of magnesium over titanium screws will be established using the FAS at the two-sided 5% test-level (Welch test) only if non-inferiority has been established for both primary endpoints. Secondary endpoints include quality of life. Discussion This study will inform care providers whether biodegradable magnesium-based implants are non-inferior to standard titanium Herbert screws for the treatment of scaphoid fractures in terms of wrist function and safety. Furthermore, superiority of magnesium-based implants may be demonstrated using MRI, which is used as surrogate endpoint for screw degradation. Trial registration DRKS, DRKS00013368. Registered Dec 04, 2017. Electronic supplementary material The online version of this article (10.1186/s12891-019-2723-9) contains supplementary material, which is available to authorized users.
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Affiliation(s)
- Sören Könneker
- Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, Hanover Medical School (MHH), Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
| | | | - Claudia Pieh
- Syntellix AG, Aegidientorplatz 2a, 30159, Hannover, Germany
| | - Christian von Falck
- Institute for Diagnostic and Interventional Radiology, Hanover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany
| | | | - Peter M Vogt
- Department of Plastic, Aesthetic, Hand and Reconstructive Surgery, Hanover Medical School (MHH), Carl-Neuberg-Straße 1, 30625, Hannover, Germany
| | - Martin H Kirschner
- Syntellix AG, Aegidientorplatz 2a, 30159, Hannover, Germany.,Department for General, Trauma and Reconstructive Surgery, Ludwig-Maximilians University of Munich, Marchioninistraße 15, 81377, Munich, Germany
| | - Andreas Ziegler
- StatSol, Moenring 2, 23560, Lübeck, Germany. .,School of Mathematics, Statistics and Computer Science, University of KwaZulu-Natal, Pietermaritzburg, South Africa.
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Aktan C, Ertan MB, Turan A, Kose O. Fixation of Small Osteochondral Fragments in a Comminuted Distal Humerus Fracture with Magnesium Bioabsorbable Screws: A Case Report. Cureus 2018; 10:e3752. [PMID: 30820372 PMCID: PMC6388848 DOI: 10.7759/cureus.3752] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022] Open
Abstract
The treatment of comminuted distal humeral fractures with free osteochondral fragments is challenging. Osteochondral fragments should be retained whenever possible and secured with implants buried beneath the articular surface to obtain a uniform articular surface. Headless compression screws and K wires are commonly used for this purpose. However, certain complications have been reported with these fixation implants in case of the non-union and osteolysis of the fragments such as migration and cartilage damage. Fixation of osteochondral fractures in distal humeral fractures using bioabsorbable implants has been rarely reported in the current literature. Herein, a patient who sustained a comminuted distal humeral fracture with multi-fragmentary osteochondral fragments is presented, and treatment with magnesium bioabsorbable compression screws is discussed.
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Affiliation(s)
- Cemil Aktan
- Department of Orthopaedics and Traumatology, University of Health Sciences, Antalya Education and Research Hospital, Antalya, TUR
| | - Mehmet B Ertan
- Department of Orthopaedics and Traumatology, University of Health Sciences, Antalya Education and Research Hospital, Antalya, TUR
| | - Adil Turan
- Department of Orthopaedics and Traumatology, University of Health Sciences, Antalya Education and Research Hospital, Antalya, TUR
| | - Ozkan Kose
- Department of Orthopaedics and Traumatology, University of Health Sciences, Antalya Education and Research Hospital, Antalya, TUR
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Kose O, Turan A, Unal M, Acar B, Guler F. Fixation of medial malleolar fractures with magnesium bioabsorbable headless compression screws: short-term clinical and radiological outcomes in eleven patients. Arch Orthop Trauma Surg 2018; 138:1069-1075. [PMID: 29696362 DOI: 10.1007/s00402-018-2941-x] [Citation(s) in RCA: 39] [Impact Index Per Article: 5.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2018] [Indexed: 11/28/2022]
Abstract
OBJECTIVE The purpose of this retrospective study was to evaluate the outcome of medial malleolar fractures treated with magnesium (MgYREZr) bioabsorbable compression screw fixation. MATERIALS AND METHODS Eleven patients with a medial malleolar fracture (either isolated or accompanied by bimalleolar or trimalleolar ankle fractures) who were treated with magnesium bioabsorbable compression screws between 2015 and 2016 in our hospital were retrospectively evaluated. Patients were monitored with a mean follow-up of 17.3 ± 4.1 months (range 12-24 months). The mechanism of injury was ground level falls in all patients. All fractures were classified as closed fractures. American Orthopedic Foot and Ankle Society's (AOFAS) scale and the visual analog scale (VAS) were used to evaluate the clinical results during the final follow-up. Bone union and a possible loss of reduction were assessed with serial radiographs. Potential complications including revision surgery and infection were recorded and reported. RESULTS There were 11 patients (4 female, 7 male) with a mean age of 41 ± 21.9 years (range 20-78 years). Six patients had Herscovici type C and five patients had type B fractures. At the final follow-up the mean AOFAS score was 94.9 ± 5.7 points (range 85-100 points) and the mean VAS score was 0.4 ± 1.2 points (range 0-4 points). Radiographic solid union was achieved in all cases. No complications were seen during the follow-up. No patients required implant removal or revision surgery. CONCLUSIONS This is the first study that investigates the use of bioabsorbable magnesium compression screws in medial malleolar fractures. The results of this study revealed that fixation of medial malleolar fractures with bioabsorbable magnesium compression screws provides adequate fixation with good functional results. LEVEL OF EVIDENCE Level IV, therapeutic, retrospective case series.
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Affiliation(s)
- Ozkan Kose
- Department of Orthopedics and Traumatology, Antalya Training and Research Hospital, University of Health Sciences, Antalya Egitim ve Arastirma Hastanesi, Soğuksu mah. Kazım Karabekir cd., Muratpaşa, 07100, Antalya, Turkey.
| | - Adil Turan
- Department of Orthopedics and Traumatology, Antalya Training and Research Hospital, University of Health Sciences, Antalya Egitim ve Arastirma Hastanesi, Soğuksu mah. Kazım Karabekir cd., Muratpaşa, 07100, Antalya, Turkey
| | - Melih Unal
- Department of Orthopedics and Traumatology, Antalya Training and Research Hospital, University of Health Sciences, Antalya Egitim ve Arastirma Hastanesi, Soğuksu mah. Kazım Karabekir cd., Muratpaşa, 07100, Antalya, Turkey
| | - Baver Acar
- Department of Orthopedics and Traumatology, Antalya Training and Research Hospital, University of Health Sciences, Antalya Egitim ve Arastirma Hastanesi, Soğuksu mah. Kazım Karabekir cd., Muratpaşa, 07100, Antalya, Turkey
| | - Ferhat Guler
- Department of Orthopedics and Traumatology, Antalya Training and Research Hospital, University of Health Sciences, Antalya Egitim ve Arastirma Hastanesi, Soğuksu mah. Kazım Karabekir cd., Muratpaşa, 07100, Antalya, Turkey
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Acar B, Unal M, Turan A, Kose O. Isolated Lateral Malleolar Fracture Treated with a Bioabsorbable Magnesium Compression Screw. Cureus 2018; 10:e2539. [PMID: 29951346 PMCID: PMC6019330 DOI: 10.7759/cureus.2539] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/10/2022] Open
Abstract
Magnesium (Mg) bioabsorbable screws are new biomaterials used in fracture fixation. In the current literature, there is only one case report on the use of magnesium bio-absorbable screws in ankle fractures. Within the present study, a 19-year-old female who sustained an isolated lateral malleolar fracture was treated with open reduction and intramedullary Mg screw fixation and then followed up for two years. Fracture union was achieved without any complication such as failure of fixation, loss of reduction, infection, or any other adverse reaction. Mg bioabsorbable screws are an alternative method of fracture fixation as compared to conventional metallic implants since they eliminate the need for implant removal.
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Affiliation(s)
- Baver Acar
- Department of Orthopaedics and Traumatology, University of Health Sciences, Medical Faculty, Antalya Education and Research Hospital, Antalya, Turkey
| | - Melih Unal
- Department of Orthopaedics and Traumatology, University of Health Sciences, Medical Faculty, Antalya Education and Research Hospital, Antalya, Turkey
| | - Adil Turan
- Department of Orthopaedics and Traumatology, University of Health Sciences, Medical Faculty, Antalya Education and Research Hospital, Antalya, Turkey
| | - Ozkan Kose
- Department of Orthopaedics and Traumatology, University of Health Sciences, Medical Faculty, Antalya Education and Research Hospital, Antalya, Turkey
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