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Bioengineering
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Medical Devices and Implants
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Medical Devices and Implants

A special issue of Bioengineering (ISSN 2306-5354). This special issue belongs to the section "Biofabrication and Biomanufacturing".

Deadline for manuscript submissions: 30 April 2024 | Viewed by 23296

Special Issue Editors

Dr. Giovanni F. Solitro

E-Mail Website
Guest Editor
LSU Health Sciences Center-Shreveport, Shreveport, LA, USA
Interests: biomechanics; hip; hand; spine; bone; gait; imaging
Special Issues, Collections and Topics in MDPI journals
Dr. Christina Salas

E-Mail Website
Guest Editor
Department of Orthopaedics & Rehabilitation, University of New Mexico, Albuquerque, NM, USA
Interests: orthopaedics; tissue biomechanics; tissue engineering; additive manufacturing; 3D bioprinting; medical device design; finite element modeling
Dr. Francesco Travascio

E-Mail Website
Guest Editor
Department of Orthopaedic Surgery, University of Miami, Coral Gables, FL, USA
Interests: fibrocartilage; tissue engineering; computational modeling; injury biomechanics; prosthetics; assistive devices; rehabilitation

Special Issue Information

Dear Colleagues,

We invite contributions for a Special Issue of Bioengineering focused on the design, prototyping, manufacturing, and experimentation of medical devices and implants. Considering the increased demand of these devices and the resultant increased healthcare costs, the clinical deployment of these solutions results in many challenges that need to be overcome. The regulatory compliance, absence of standardized testing procedures, manufacturability, and efficacy of these devices are examples of issues that need to be addressed to launch or maintain a product on the market with satisfactory clinical results. Embedded Artificial Intelligence in diagnostic tools, big-data-driven design processes, wireless communications for real-time monitoring, and finite element modeling for verification and validation are all examples of novel but now well-established technologies that have positively impacted product development. Further, the widespread use of additive manufacturing has boosted patient-specific design and implant development. More recently, bioprinting has been used in medicine to help to study or recreate almost every tissue, cartilage, and organ in the body. The translational role of these solutions is often overlooked, and not much space is given in clinical journals. Therefore, this Special Issue aims to collect studies performed on medical devices and implants strictly related to their development, prototyping, evaluation of efficacy, and safety. Discussion and critical analysis of existing testing methods and standards is welcome, as are original studies on new concepts. We look forward to receiving your groundbreaking contributions.

Dr. Giovanni Francesco Solitro
Dr. Christina Salas
Dr. Francesco Travascio
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Bioengineering is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • implant
  • medical devices
  • prototyping
  • 3D printing
  • scaffolds
  • tissue engineering
  • additive manufacturing

Published Papers (10 papers)

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Research

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11 pages, 2222 KiB  
Article
Influence of a Modified Procedure of Joining Ceramic Head and Adapter Sleeve on the Stem Taper in Revision: An Experimental Study
by Sandra Hunger, Christian Rotsch, Florian Günther, Welf-Guntram Drossel and Christoph-Eckhard Heyde
Bioengineering 2024, 11(2), 170; https://doi.org/10.3390/bioengineering11020170 - 09 Feb 2024
Viewed by 854
Abstract
In revision operations, ceramic heads of modular hip implants can be replaced. As the surface of the stem taper can be damaged, additional adapter sleeves are applied. The components are usually connected manually by the surgeon in a one-step procedure by hammer impacts. [...] Read more.
In revision operations, ceramic heads of modular hip implants can be replaced. As the surface of the stem taper can be damaged, additional adapter sleeves are applied. The components are usually connected manually by the surgeon in a one-step procedure by hammer impacts. In this study, we investigated a two-step joining procedure with reproducible impaction force. First, the adapter sleeve and head were joined quasi-statically with a force of 2 kN using an assembly device. In the second step, these components were applied to the stem taper using a pulse-controlled instrument. For reference, the joints were assembled according to standard conditions using a tensile testing machine. An average pull-off force of 1309 ± 201 N was achieved for the components joined by the instrument, and the average measured values for the components joined by the testing machine were 1290 ± 140 N. All specimens achieved a force >350 N when released and therefore met the acceptance criterion defined for this study. This study showed that a modified procedure in two steps with a defined force has a positive effect on the reproducibility of the measured joining forces compared to previous studies. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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12 pages, 3751 KiB  
Article
Evaluating the Feasibility and Reproducibility of a Novel Insertion Method for Modular Acetabular Ceramic Liners
by Sandra Hunger, Alexander Seidler, Christian Rotsch, Christoph-Eckhard Heyde and Welf-Guntram Drossel
Bioengineering 2023, 10(10), 1180; https://doi.org/10.3390/bioengineering10101180 - 11 Oct 2023
Cited by 2 | Viewed by 965
Abstract
Modern hip implants have a modular design. In case of wear or other damage it allows surgeons to change the tribological partners, i.e., the acetabular liner and femoral ball. In both revision and primary surgery, the secure joining of the implant components is [...] Read more.
Modern hip implants have a modular design. In case of wear or other damage it allows surgeons to change the tribological partners, i.e., the acetabular liner and femoral ball. In both revision and primary surgery, the secure joining of the implant components is important for the success of the operation. The two components, namely the ceramic liner and hip cup, are connected via a conical press connection and should be concentrically aligned to avoid chipping. Malseated liners can reduce the life span in situ. The amount of the joining force, which is usually applied via a hammer, depends on the surgeon. In this study, an alternative joining method for acetabular ceramic liners in hip cups was investigated, which intends to make the process more reproducible and thus safer. For this purpose, a handpiece was used to apply a defined force impulse of 4 kN. For the concentric alignment of a ceramic liner in the hip cup, an adapter was developed based on findings via a qualitative finite element (FE) analysis. Insertion and pushout tests of the acetabular cup–liner connection were performed in the laboratory with the new instrument (handpiece with the connected adapter) to evaluate the functionality of the instrument and the reproducibility of the new insertion method. For comparison, liners and acetabular cups were joined using a testing machine according to the standard. The presented results demonstrate the technical proof-of-concept of the new joining method under laboratory conditions. They meet the acceptance criteria of established manufacturers, which proves the equivalency to proven methods for joining modular implant components. To verify the improvement of the new joining method compared to the conventionally used joining method, an application-oriented study with different surgeons and the new joining instrument under clinical conditions is necessary. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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16 pages, 3462 KiB  
Article
Treatment of Severe Pulmonary Regurgitation in Enlarged Native Right Ventricular Outflow Tracts: Transcatheter Pulmonary Valve Replacement with Three-Dimensional Printing Guidance
by Yiwei Wang, Ping Jin, Xin Meng, Lanlan Li, Yu Mao, Minwen Zheng, Liwen Liu, Yang Liu and Jian Yang
Bioengineering 2023, 10(10), 1136; https://doi.org/10.3390/bioengineering10101136 - 28 Sep 2023
Cited by 1 | Viewed by 960
Abstract
Background: Severe pulmonary regurgitation (PR) often occurs following a transannular patch repair of tetralogy of Fallot, resulting in an enlarged native right ventricular outflow tract (nRVOT) with varying shapes. Methods: We conducted a single-center study with eight patients having severe PR and enlarged [...] Read more.
Background: Severe pulmonary regurgitation (PR) often occurs following a transannular patch repair of tetralogy of Fallot, resulting in an enlarged native right ventricular outflow tract (nRVOT) with varying shapes. Methods: We conducted a single-center study with eight patients having severe PR and enlarged nRVOT (diameters ≥ 29 mm). Transcatheter pulmonary valve replacement (TPVR) was performed using the self-expanding PT-Valve. Preoperative evaluation included echocardiography, computed tomography, and magnetic resonance imaging. A 3D-printed model of the nRVOT was used for preoperative assessment. Follow-up data were collected in 1-year follow-up. Results: PT-Valve was successfully implanted in all patients, resulting in immediate improvement of severe PR. Pulmonary artery diastolic pressure increased significantly (p < 0.001). No deaths or coronary compression occurred during the procedure. Over a 1-year follow-up, no stent displacement or fracture occurred. Only two patients had trace paravalvular leaks. Magnetic resonance imaging revealed a reversal of right ventricular remodeling, with a significant reduction in right ventricular end-diastolic volume index (p < 0.001) and improved right ventricular ejection fraction (p < 0.001). All patients achieved primary endpoints. Conclusion: 3D printing-guided PT-Valve implantation in enlarged nRVOT for severe PR is safe and effective, expanding TPVR indications and offering potential treatment for a broader patient population. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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13 pages, 84995 KiB  
Article
Acetabular Revision with McMinn Cup: Development and Application of a Patient-Specific Targeting Device
by Zoltán Csernátony, Sándor Manó, Dániel Szabó, Hajnalka Soósné Horváth, Ágnes Éva Kovács and Loránd Csámer
Bioengineering 2023, 10(9), 1095; https://doi.org/10.3390/bioengineering10091095 - 18 Sep 2023
Viewed by 858
Abstract
Background: Surgeries of severe periacetabular bone defects (Paprosky ≥ 2B) are a major challenge in current practice. Although solutions are available for this serious clinical problem, they all have their disadvantages as well as their advantages. An alternative method of reconstructing such extensive [...] Read more.
Background: Surgeries of severe periacetabular bone defects (Paprosky ≥ 2B) are a major challenge in current practice. Although solutions are available for this serious clinical problem, they all have their disadvantages as well as their advantages. An alternative method of reconstructing such extensive defects was the use of a cup with a stem to solve these revision situations. As the instrumentation offered is typically designed for scenarios where a significant bone defect is not present, our unique technique has been developed for implantation in cases where reference points are missing. Our hypothesis was that a targeting device designed based on the CT scan of a patient’s pelvis could facilitate the safe insertion of the guiding wire. Methods: Briefly, our surgical solution consists of a two-step operation. If periacetabular bone loss was found to be more significant during revision surgery, all implants were removed, and two titanium marker screws in the anterior iliac crest were percutaneously inserted. Next, by applying the metal artifact removal (MAR) algorithm, a CT scan of the pelvis was performed. Based on that, the dimensions and positioning of the cup to be inserted were determined, and a patient-specific 3D printed targeting device made of biocompatible material was created to safely insert the guidewire, which is essential to the implantation process. Results: In this study, medical, engineering, and technical tasks related to the design, the surgical technique, and experiences from 17 surgical cases between February 2018 and July 2021 are reported. There were no surgical complications in any cases. The implant had to be removed due to septic reasons (independently from the technique) in a single case, consistent with the septic statistics for this type of surgery. There was not any perforation of the linea terminalis of the pelvis due to the guiding method. The wound healing of patients was uneventful, and the implant was fixed securely. Following rehabilitation, the joints were able to bear weight again. After one to four years of follow-up, the patient satisfaction level was high, and the gait function of the patients improved a lot in all cases. Conclusions: Our results show that CT-based virtual surgical planning and, based on it, the use of a patient-specific 3D printed aiming device is a reliable method for major hip surgeries with significant bone loss. This technique has also made it possible to perform these operations with minimal X-ray exposure. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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10 pages, 3873 KiB  
Article
‘Distraction Vaginogenesis’: Preliminary Results Using a Novel Method for Vaginal Canal Expansion in Rats
by Hannah Meyer, Lexus Trosclair, Sean D. Clayton, Collyn O’Quin, Zachary Connelly, Ross Rieger, Nhi Dao, Ahmed Alhaque, Andrew Minagar, Luke A. White, Giovanni Solitro, Mila Shah-Bruce, Valerie L. Welch, Stephanie Villalba, Jonathan Steven Alexander and Donald Sorrells
Bioengineering 2023, 10(3), 351; https://doi.org/10.3390/bioengineering10030351 - 12 Mar 2023
Viewed by 1937
Abstract
Vaginal atresia is seen in genetic disorders such as Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, which can cause significant sexual dysfunction. Current treatments include surgical reconstruction or mechanical dilation of the vaginal canal. Mechanical dilation requires patients to be highly motivated and compliant while surgical reconstruction [...] Read more.
Vaginal atresia is seen in genetic disorders such as Mayer–Rokitansky–Küster–Hauser (MRKH) syndrome, which can cause significant sexual dysfunction. Current treatments include surgical reconstruction or mechanical dilation of the vaginal canal. Mechanical dilation requires patients to be highly motivated and compliant while surgical reconstruction has high rates of complications. This study evaluated a novel vaginal expansion sleeve (VES) method as an alternative treatment for vaginal atresia. The proprietary cylindrical VES is a spring-like device consisting of polyethylene terephthalate helicoid trusses capped at each end with a fixed diameter resin cap for fixation within tissues. Following the development of the VES and mechanical characterization of the force–length relationships within the device, we deployed the VES in Sprague Dawley rat vaginas anchored with nonabsorbable sutures. We measured the VES length–tension relationships and post-implant vaginal canal expansion ex vivo. Vaginal histology was examined before and after implantation of the VES devices. Testing of 30 mm sleeves without caps resulted in an expansion force of 11.7 ± 3.4 N and 2.0 ± 0.1 N at 50% and 40%, respectively. The implanted 20 mm VES resulted in 5.36 mm ± 1.18 expansion of the vaginal canal, a 32.5 ± 23.6% increase (p = 0.004, Student t test). Histological evaluation of the VES implanted tissue showed a significant thinning of the vaginal wall when the VES was implanted. The novel VES device resulted in a significant expansion of the vaginal canal ex vivo. The VES device represents a unique alternative to traditional mechanical dilation therapy in the treatment of vaginal atresia and represents a useful platform for the mechanical distension of hollow compartments, which avoids reconstructive surgeries and progressive dilator approaches. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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27 pages, 6421 KiB  
Article
Planar Elliptical Inductor Design for Wireless Implantable Medical Devices
by Muhammad Farooq, Bilal Amin, Adnan Elahi, William Wijns and Atif Shahzad
Bioengineering 2023, 10(2), 151; https://doi.org/10.3390/bioengineering10020151 - 23 Jan 2023
Cited by 3 | Viewed by 3291
Abstract
Wireless implantable medical devices (WIMDs) have seen unprecedented progress in the past three decades. WIMDs help clinicians in better-understanding diseases and enhance medical treatment by allowing for remote data collection and delivering tailored patient care. The wireless connectivity range between the external reader [...] Read more.
Wireless implantable medical devices (WIMDs) have seen unprecedented progress in the past three decades. WIMDs help clinicians in better-understanding diseases and enhance medical treatment by allowing for remote data collection and delivering tailored patient care. The wireless connectivity range between the external reader and the implanted device is considered one of the key design parameters in WIMD technology. One of the common modes of communication in battery-free WIMDs is inductive coupling, where the power and data between the reader and the implanted device are transmitted via magnetically coupled inductors. The design and shape of these inductors depend on the requirements of the application. Several studies have reported models of standard planar inductors such as circular, square, hexagonal, and octagonal in medical applications. However, for applications, constrained by narrow implantable locations, elliptical planar inductors may perform better than standard-shaped planar inductors. The aim of this study is to develop a numerical model for elliptical inductors. This model allows for the calculation of the inductance of the elliptical planar inductor and its parasitic components, which are key design parameters for the development of WIMDs powered by inductive coupling. An area transformation technique is used to transform and derive elliptical inductor formulas from standard circular inductor formulas. The proposed model is validated for various combinations of the number of turns, trace width, trace separation, and different inner and outer diameters of the elliptical planar inductor. For a thorough experimental validation of the proposed numerical model, more than 75 elliptical planar inductors were fabricated, measured, and compared with the numerical output of the proposed model. The mean error between the measured inductor parameters and numerical estimates using the proposed model is <5%, with a standard deviation of <3.18%. The proposed model provides an accurate analytical method for estimating and optimizing elliptical planar inductor parameters using a combination of current sheet expression and area transformation techniques. An elliptical planar inductor integrated with a sensing element can be used as a wireless implant to monitor the physiological signal from narrow implantation sites. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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15 pages, 3958 KiB  
Article
An Inductively Powered Implantable System to Study the Gastrointestinal Electrophysiology in Freely Behaving Rodents
by Dylan T. Berry, Joanne Choi, Calla A. Dexheimer, Morgan A. Verhaalen and Amir Javan-Khoshkholgh
Bioengineering 2022, 9(10), 530; https://doi.org/10.3390/bioengineering9100530 - 06 Oct 2022
Cited by 3 | Viewed by 1450
Abstract
Chronic studies in the fasting and fed states of conscious subjects are fundamental for understanding the pathophysiological significance of functional gastrointestinal (GI) disorders and motility dysfunctions. To study the electrophysiology of the GI tract in the long term, the development of gastric implants [...] Read more.
Chronic studies in the fasting and fed states of conscious subjects are fundamental for understanding the pathophysiological significance of functional gastrointestinal (GI) disorders and motility dysfunctions. To study the electrophysiology of the GI tract in the long term, the development of gastric implants is essential. This paper presents the development of an implantable system capable of monitoring the bioelectrical activity of the gastric system and modulating the activity in freely behaving rodents. The system consists of a miniature-sized implantable unit (IU), a stationary unit (SU) that communicates with the IU over a 2.4 GHz far-field radio frequency (RF) bidirectional link, and a charging unit (CU) that establishes an inductive 13.56 MHz near-field communication (NFC) with the IU, implementing an adaptive wireless power transfer (WPT). The CU can generate an adjustable power between +20 dBm and +30 dBm, and, in the presence of body movements and stomach motility, can deliver a constant rectified voltage to the IU. The live subject’s exposure to the electromagnetic WPT in the developed system complies with the RF energy absorption restrictions for health and safety concerns. The system can be utilized to investigate the relationship between functional GI disorders and dysrhythmias in the gastric bioelectrical activity and study the potential of electroceutical therapies for motility dysfunctions in clinical settings. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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Review

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19 pages, 3719 KiB  
Review
A Review of Barbed Sutures—Evolution, Applications and Clinical Significance
by Karuna Nambi Gowri and Martin W. King
Bioengineering 2023, 10(4), 419; https://doi.org/10.3390/bioengineering10040419 - 27 Mar 2023
Cited by 4 | Viewed by 4661
Abstract
Surgical ligatures are a critical component of any surgical procedure since they are the device that provides immediate post-surgical tissue apposition. There have been several studies to improve the design and use of these wound closure devices for different surgical procedures. Yet, there [...] Read more.
Surgical ligatures are a critical component of any surgical procedure since they are the device that provides immediate post-surgical tissue apposition. There have been several studies to improve the design and use of these wound closure devices for different surgical procedures. Yet, there is no standardized technique or device that can be used for any specific application. Over the last two decades, there has been an increased focus on the innovative surgical sutures known as knotless or barbed sutures, along with studies focusing on their advantages and disadvantages in clinical environments. Barbed sutures were invented to reduce the localized stress on the approximated tissues as well as facilitating the surgical technique and improving the clinical outcome for the patient. This review article discusses how barbed sutures evolved from the first patent published in 1964 and how these barbed sutures influence the surgical outcomes in different procedures ranging from cosmetic surgery to orthopedic surgery performed on both human patients and animals. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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13 pages, 2021 KiB  
Review
The Safety and Effectiveness of Early, Progressive Weight Bearing and Implant Choice after Traumatic Lower Extremity Fracture: A Systematic Review
by Daniel W. Flowers, Erin McCallister, Ricki Christopherson and Erin Ware
Bioengineering 2022, 9(12), 750; https://doi.org/10.3390/bioengineering9120750 - 01 Dec 2022
Cited by 2 | Viewed by 2814
Abstract
The goal of this systematic review was to examine existing evidence on the effectiveness of early, progressive weight bearing on patients after traumatic lower extremity fractures and relate these findings to device/implant choice. A search of the literature in PubMed/Medline, Embase, Web of [...] Read more.
The goal of this systematic review was to examine existing evidence on the effectiveness of early, progressive weight bearing on patients after traumatic lower extremity fractures and relate these findings to device/implant choice. A search of the literature in PubMed/Medline, Embase, Web of Science, and the Cochrane Library was performed through January 2022. Randomized controlled trials and non-randomized, prospective longitudinal investigations of early, progressive weight bearing in skeletally mature adults after traumatic lower extremity fracture were included in the search, with 21 publications included in the final analysis. A summary of the loading progressions used in each study, along with the primary and additional outcomes, is provided. The progression of weight bearing was variable, dependent on fracture location and hardware fixation; however, overall outcomes were good with few complications. Most studies scored “high” on the bias tools and were predominately performed without physical therapist investigators. Few studies have investigated early, progressive weight bearing in patients after traumatic lower extremity fractures. The available clinical evidence provides variable progression guidelines. Relatively few complications and improved patient function were observed in this review. More research is needed from a rehabilitation perspective to obtain graded progression recommendations, informed by basic science concepts and tissue loading principles. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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Other

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35 pages, 1334 KiB  
Systematic Review
Biodegradable Bone Implants as a New Hope to Reduce Device-Associated Infections—A Systematic Review
by José C. C. Paiva, Luís Oliveira, Maria Fátima Vaz and Sofia Costa-de-Oliveira
Bioengineering 2022, 9(8), 409; https://doi.org/10.3390/bioengineering9080409 - 22 Aug 2022
Cited by 10 | Viewed by 3307
Abstract
Bone fractures often require fixation devices that frequently need to be surgically removed. These temporary implants and procedures leave the patient more prone to developing medical device-associated infections, and osteomyelitis associated with trauma is a challenging complication for orthopedists. In recent years, biodegradable [...] Read more.
Bone fractures often require fixation devices that frequently need to be surgically removed. These temporary implants and procedures leave the patient more prone to developing medical device-associated infections, and osteomyelitis associated with trauma is a challenging complication for orthopedists. In recent years, biodegradable materials have gained great importance as temporary medical implant devices, avoiding removal surgery. The purpose of this systematic review was to revise the literature regarding the use of biodegradable bone implants in fracture healing and its impact on the reduction of implant-associated infections. The systematic review followed the PRISMA guidelines and was conducted by searching published studies regarding the in vivo use of biodegradable bone fixation implants and its antibacterial activity. From a total of 667 references, 23 studies were included based on inclusion and exclusion criteria. Biodegradable orthopedic implants of Mg-Cu, Mg-Zn, and Zn-Ag have shown antibacterial activity, especially in reducing infection burden by MRSA strains in vivo osteomyelitis models. Their ability to prevent and tackle implant-associated infections and to gradually degrade inside the body reduces the need for a second surgery for implant removal, with expectable gains regarding patients’ comfort. Further in vivo studies are mandatory to evaluate the efficiency of these antibacterial biodegradable materials. Full article
(This article belongs to the Special Issue Medical Devices and Implants)
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