Orthopedic Devices Research Articles (Page 1)

Medical registries are structured tools for collecting, monitoring, and analyzing clinical data for epidemiological purposes, as well as for improving patient care. In the field of orthopaedics, arthroplasty registries help monitor implant performance, identify complications, and standardize surgical practices. In Burkina Faso, despite the increase in the number of joint replacements and epidemiological features such as sickle cell disease, no national registry exists. This work aims to establish a prototype of a registry tailored to local realities. A cross-sectional descriptive study was conducted, combining a literature review to assess the existing situation and a questionnaire survey administered to orthopaedic surgeons in Burkina Faso. The analysis was conducted with Python 3.12.3, integrating descriptive statistics, visualizations, and synthesis of functional expectations. To date, there is no structured system for monitoring orthopaedic implantable devices at the national level. Orthopedists during the survey expressed the need for a centralized, secure, and accessible system, allowing the traceability of implants, the monitoring of complications, and the production of reports that can guide the choice of prostheses. Priority features include web and smartphone access, prosthesis survival statistics, and implant selection recommendations. The main constraints identified are the lack of a homogeneous IT infrastructure and limited financial resources. Based on the needs collected, a prototype was modeled, including UML diagrams, specifications, and web and smartphone models. The establishment of a national arthroplasty registry is perceived as a strategic lever by practitioners to improve the quality of care and strengthen the surveillance of implantable devices. The prototype is intended to be a contextual, secure, and scalable solution. A pilot phase is recommended, with strong institutional support (Ministry of Health, National Orthopedics society) and participatory governance to ensure user buy-in and the sustainability of the registry.

Introduction Chronic biomaterial-associated infections (BAI), particularly those involving biofilm formation, represent a significant clinical challenge. Despite intensive experimental research, few in vivo models with chronic biofilm formation are available, mainly using vertebrates. These models are often costly and subject to strict animal welfare regulations. Most simple non-vertebrates in vivo models, such as Galleria mellonella , has rarely been investigated to study chronic infections due to their limited lifetime. Aim The general aim of this study was to establish a chronic orthopaedic infection model with mature biofilm formation using an in vitro-in vivo approach with the CDC biofilm reactor (CBR) and G. mellonella . Methods Three orthopaedic-related S. aureus strains were selected to form biofilms on the surface of Kirschner wires (K-wires) over an incubation period of up to 7 days using either a static (microplate model) or a dynamic flow system (CBR; BioSurface Technologies). After biofilm maturation periods of 1 and 7 days, these implants were washed and then used: (i) to characterize the biofilms (quantitative cultures, SEM, 3D-CLSM, and gene expression of biofilm markers), (ii) to assess in vitro rifampicin susceptibility (EUCAST), and (iii) to be introduced into G. mellonella larvae for an additional 5 days. Rifampicin larval administration (80 µg/g) was assessed as a surrogate marker for biofilm maturation using Kaplan-Meier analysis. Results The data demonstrated that dynamic flow maturation in the CBR for 7 days with subsequent implantation into G. mellonella larvae led to mature biofilm formation with drastically decreased rifampicin effectiveness. Furthermore, unlike biofilms formed under static conditions, dynamic flow conditions significantly increased biofilm formation after 7 days in vitro . This approach demonstrated an increase of 2-4 log 10 CFU on K-wires and thicker biofilms, partly due to enhanced secretion of extracellular matrix components, before introduction into the larvae. Conclusions Overall, we established an in vitro - in vivo hybrid method to mimic chronic orthopaedic implant infection with mature biofilm formation. The use of a high shear flow device to initiate strong biofilm formation and maturation on orthopaedic device surfaces prior to introduction into larvae proved essential. This high-throughput and cost-effective method could contribute to assessing new treatment strategies targeting chronic biofilm infections.

Staphylococcus aureus is the leading cause of global bacterial mortality. While S. aureus can cause a variety of diseases, orthopedic device infections are particularly challenging due to the need for additional surgeries with associated morbidity. Conventional vaccine technology has failed to prevent S. aureus orthopedic device infection in animal models and clinical trials. In this study, injectable scaffold vaccines are presented as a modality to augment host immunity and mitigate orthopedic device infection. These scaffold vaccines increased cytokine production, antigen-specific cell-mediated immune responses, and humoral responses. When loaded with a pool of antigens collected via an engineered human opsonin, these scaffold vaccines decreased the bacterial burden against methicillin-susceptible and methicillin-resistant S. aureus (MRSA) strains in a murine model of orthopedic device infection. Scaffold vaccination was ~100× more effective in decreasing S. aureus burden compared to prior published immunotherapy attempts in murine models of orthopedic device infection. Scaffold vaccination was also effective when using a monovalent protein-based antigen. Scaffold vaccination is an alternative strategy to facilitate more robust immunity in scenarios where conventional bolus vaccines have not been effective.

Introduction Femoral loading leading to a fracture is known to vary with anthropometry, and patient-specific finite element models have provided important insights into fracture prediction but are often very time consuming to generate. Additionally, existing parametric models do not simultaneously account for variations in both femur geometry and bone density distribution and remain limited to either the femoral shaft or the proximal femur. This inhibits their ability to predict fractures involving both the shaft and proximal regions. Methods In the present study, a novel parametric femur modeling strategy was developed to create whole femur models based on stature, BMI, and age input, including density distribution and geometrical variations, for fracture loading predictions. A statistical shape and appearance femur model was developed based on an input set of CT scans of healthy female femurs (N = 18) between the ages of 50 and 70. Thereafter, multilinear regressions were used to relate principal components to the subject anthropometric characteristics and develop parametric models. The developed parametric models were evaluated using traditional patient-specific models for their potential to represent the influence of changing patient stature, BMI, and age on femoral fractures. Femoral fracture load in three-point bending, axial torsion, and lateral fall cases was predicted using the parametric as well as subject-specific femur models. Results The developed parametric model was able to predict femoral fracture load variations due to changing anthropometry and age with an average difference of 4.85% compared with predictions using subject-specific models. Discussion Therefore, this novel parametric femur model can predict fracture loading while directly incorporating the influence of changing patient anthropometry. In the future, the model could support the development of orthopedic devices tailored to specific patient anthropometries to help mitigate femoral fractures.

The goal of musculoskeletal research is to translate scientific innovations from basic science to bedside applications. This process requires substantial investments in research and development, regulatory approvals, manufacturing, and commercialization of orthopaedic devices and solutions. Since 2020, less than 2% of annual National Institutes of Health (NIH) awards have supported musculoskeletal research. Limited public funding and institutional resources have driven clinicians and researchers to seek alternative partnerships. The orthopaedic industry frequently collaborates with clinician scientists to develop evidence demonstrating the safety, efficacy, and clinical benefits of products. Partnerships are generally classified as either "industry-initiated research" or "investigator-initiated research," with the initiating party determining the idea, study design, and data analysis. Funding, operational support, and oversight vary accordingly. Industry partners can provide financial and operational resources, while researchers contribute scientific expertise, fostering effective collaboration and execution of various preclinical and clinical studies. Successful collaboration requires navigating potential hurdles. Key considerations include selecting partners with aligned goals, mitigating perceived bias, managing conflicts of interest, clarifying data ownership and reporting responsibilities, determining publications or licensing rights, and understanding legal and compliance requirements. The purpose of this study is to provide practical insights for overcoming these barriers. By fostering strategic industry-academic collaborations, researchers can identify actionable approaches for securing support. Strengthening these partnerships for both basic science and clinical studies offers the potential to drive translational and applied research, address unmet clinical needs, and advance musculoskeletal care.

Biodegradable zinc-based alloys have recently emerged as promising candidates for temporary biomedical implants due to their favorable biocompatibility, appropriate degradation rate, and relatively simple processing. In this study, the Zn-0.1Mg alloy was investigated after being processed by means of a two-step equal-channel angular pressing (ECAP) route, consisting of the first pass at 150 °C followed by a second pass at room temperature. The mechanical properties were evaluated using uniaxial tensile tests at different strain rates, while the microstructure and phase composition were analyzed using synchrotron hard X-ray diffraction and transmission electron microscopy (TEM). The processed alloy exhibited a remarkable enhancement in both strength and ductility compared to the annealed state. At the lowest applied strain rate, a fracture elongation of up to 240% was achieved at room temperature, representing a unique manifestation of superplasticity under ambient conditions. Diffraction analysis confirmed the stability of the supersaturated Zn matrix with minor Mg2Zn11 intermetallic phase. TEM observations revealed an ultrafine-grained microstructure and activation of non-basal slip systems, which enabled efficient plastic flow. These findings demonstrate that controlled severe plastic deformation provides an effective pathway for tailoring Zn-Mg alloys, opening opportunities for their use in the next generation of bioresorbable low-to-moderate load orthopedic fixation devices, e.g., plates, screws, suture anchors and craniofacial miniplates.

Objectives: Ultra High Molecular Weight Polyethylene (UHMWPE) is extensively used in orthopedic and implantable medical devices, yet data on its genotoxic potential remain limited. This study aimed to comprehensively assess the mutagenic, clastogenic, and aneugenic potential of UHMWPE extracts using two standard in vitro assays. Methods: Following ISO 10993 and OECD guidelines (471 and 473), UHMWPE extracts were prepared using polar and non-polar solvents. Mutagenicity was evaluated using Salmonella typhimurium strains (TA98, TA100, TA102, TA1535, and TA1537) with and without S9 metabolic activation. In vitro Chromosomal aberration analysis was performed on cultured human peripheral blood lymphocytes exposed to UHMWPE extracts at 25%, 50%, and 100% concentrations under both short-term (±S9) and longterm (-S9) exposure conditions. Findings: In the Ames test, no significant increase in revertant colonies was observed across strains, indicating no mutagenic activity. Revertant counts for the test material ranged from 125 ± 6 to 130 ± 6 CFU/plate, similar to negative controls (e.g., TA100: 126 ± 6 vs. 136 ± 13). In contrast, positive controls like mitomycin C showed marked increases (e.g., TA102: 703 ± 35; TA1537: 351 ± 15), confirming assay validity. In the chromosomal aberration assay, the test material induced no significant structural or numerical aberrations, with aberrant cells at 1%–4% (vs. 14%–22% for positives). The mitotic index remained within normal range (8.5 with S9; 8.8 and 7.6 without S9), and numerical aberrations stayed below 1%, unlike positive controls (up to 5.7%). Novelty: This study uniquely evaluated UHMWPE extractables (not wear particles) for genotoxicity using both assays under internationally accepted regulatory protocols. It provides new safety evidence supporting the non – mutagenic and non – clastogenic nature of UHMWPE in medical device applications. Keywords: UHMWPE; Genotoxicity; Ames Test; Chromosomal Aberration; Medical Devices; Biocompatibility

Inherent variation in surface roughness of Selective Laser Melting (SLM) printed titanium caused by build angle changes the mechanomicrobiocidal effectiveness of nanostructures.

Orthopaedic device performance is often evaluated using standard methods, but musculoskeletal models can provide additional insights. This study investigates the implementation of biomechanical frameworks to enhance our understanding of orthopaedic device performance. One example presented is stress shielding in a shoulder implant construct. By incorporating realistic material properties and activities of daily living, models were developed to understand device performance under physiological conditions.A shoulder implant construct finite element model was created to evaluate stress shielding. A mean bone was developed from subject-specific data, which involved calculating the statistical bone shape and volumetric intensity data derived from CT scans. These volumetric data were converted to Young's modulus to represent bone material properties. A shoulder implant was added to the bone, and loads from six different activities of daily living were applied to the construct. Stress shielding was evaluated for individual activities, as well as for the aggregate of all activities.The analysis showed the effects of stress shielding under different musculoskeletal loads. Differences in stress shielding resulted from the different directions and magnitudes of the loading. The combined effect of all activities was also evaluated, and showed that the area with the highest stress shielding was on the proximal end of the construct.This framework shows the potential for biomechanical models in evaluating orthopaedic devices. The findings highlight the importance of considering the sources of variability within the system, and the power of modelling to understand their effects.

Introduction. Spina bifida, particularly its most common form, myelomeningocele (MMC), is a severe congenital malformation associated with high neonatal morbidity and long-term disability. Since 2015, our center has been performing intrauterine repair of MMC using a modified open surgical technique. Objective. To describe the obstetric and perinatal outcomes, the need for treatment of hydrocephalus, and the ability to walk in children who underwent open fetal surgery for repair of spinal dysraphism, and to compare these data with those published in the Management of Myelomeningocele Study (MOMS). Population and methods. Retrospective observational study of 102 consecutive cases operated on between 2015 and 2023. Maternal, neonatal, and neurological variables were analyzed in the mediumterm follow-up. Results. The mean gestational age at the time of surgery was 26.1 weeks. Maternal and neonatal complication rates were similar to or lower than those reported in the MOMS study. The need for ventriculoperitoneal shunting at 12 months was 23.8%. At 30 months, 84.8% of patients were walking with or without orthopedic devices. Conclusion. Open fetal repair of MMC at our center, performed by a multidisciplinary team using a modified surgical technique, presented a favorable maternal-fetal safety profile. The perinatal and neurological outcomes obtained are comparable to those of international reference centers, with a low rate of ventriculoperitoneal shunting and a high percentage of children able to walk at 30 months of age. These findings support the continuation and optimization of this intervention in experienced centers.

A bioresorbable cannulated bone screw was developed using PLA/PCL-based composites reinforced with hydroxyapatite (HA) and titanium dioxide (TiO2), two additives previously reported to enhance mechanical compliance, biocompatibility, and molding feasibility in biodegradable polymer systems. The design incorporated a crest-trimmed thread and a strategically positioned gate in the thin-wall zone opposite the hexagonal socket to preserve torque-transmitting geometry during micromolding. To investigate shrinkage behavior, a Taguchi orthogonal array was employed to systematically vary micromolding parameters, generating a structured dataset for training a back-propagation neural network (BPNN). Analysis of variance (ANOVA) identified melt temperature as the most influential factor affecting shrinkage quality, defined by a combination of shrinkage rate and dimensional variation. A hybrid AI framework integrating the BPNN with genetic algorithms and particle swarm optimization (GA-PSO) was applied to predict the optimal shrinkage conditions. This is the first use of BPNN-GA-PSO for cannulated bone screw molding, with the shrinkage rate as a targeted output. The AI-predicted solution, interpolated within the Taguchi design space, achieved improved shrinkage quality over all nine experimental groups. Beyond the specific PLA/PCL-based systems studied, the modeling framework-which combines geometry-specific gate design and normalized shrinkage prediction-offers broader applicability to other bioresorbable polymers and hollow implant geometries requiring high-dimensional fidelity. This study integrates composite formulation, geometric design, and data-driven modeling to advance the precision micromolding of biodegradable orthopedic devices.

Coupled effect of substrate welding and MAO treatment on surface and corrosion behavior of ZM21 magnesium for orthopedic fixation devices

Advancing metallic implant: A review of magnesium alloys as bio-absorbable alternatives to orthopedic devices

Orthopedic Device Infections in Children.

Background The U.S. Centers for Medicaid & Medicare Services (CMS) reports payments from industry companies to physicians and teaching hospitals through the Open Payments database. We explore the relationship between industry and teaching hospitals regarding industry payments for orthopaedic medical devices. Objective To explore changes in orthopaedic surgery research payments to teaching hospitals by analyzing CMS Open Payments data. Methods Orthopaedic surgery payments between 2016 and 2021 were analyzed using the CMS Open Payments database. Teaching hospitals were identified from the database as a covered payment recipient and the hospital name was recorded. Payment amount, industry company name, device category, and the name, state, and geographical region of the teaching hospital were recorded for each payment. Results There were 1,270 payments recorded to 90 teaching hospitals. The median payment value has no trend (R=0.014; p=0.618). The largest number of payments were made to UH Cleveland Medical Center (Cleveland, OH) (12.0%), followed by Charleston Area Medical Center (Charleston, WV) (6.6%) and Mary Hitchcock Memorial Hospital (Lebanon, NH) (6.3%). Vertos Medical (21.5%) and Medical Device Business Services (21.3%) made the most industry payments to teaching hospitals. Industry payments were primarily made towards devices utilized for the lower extremity (64.3%) and spine (29.3%). Lower extremity devices had a median payment value of $1,393.75, while devices used for the spine had a median payment value of $800.00 (p<0.001). Conclusion There is no apparent trend in the annual median payment to teaching hospitals from orthopaedic medical device companies.

Antimicrobial peptides (AMPs) are increasingly emerging as alternatives to conventional antibiotics. This study compared the antibacterial activity of two decapeptides, KSL and KSL-W, and a 23-residue peptide, Dadapin-1, against bacterial species that colonize orthopedic implants, with the aim of identifying the most effective peptide for future AMP-based anti-infective orthopedic biomaterials. Staphylococcus aureus ATCC 25923 was the reference strain. The minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), and minimum biofilm inhibitory concentration (MBIC) of the AMPs were determined in both undiluted and diluted Mueller–Hinton Broth II (MHB II) to gain a simplified perspective on the potential interference of bioenvironments. The MBICs of the AMPs were close to their MICs. In diluted broth, a concentration of 3.91 μg/mL of KSL or KSL-W was bactericidal against staphylococci and prevented biofilm formation. An eight-fold higher concentration of Dadapin-1 was required to achieve bactericidal activity. Undiluted MHB II significantly hindered the antibacterial activity of KSL and Dadapin-1, while KSL-W was notably less affected. The values of LoA, a newly developed indicator of loss of activity, confirmed these findings. Bacterial species and strain influenced LoA. Furthermore, KSL-W exhibited a protective effect on osteoblasts co-cultured with S. aureus ATCC 25923. Overall, KSL-W emerged as the most promising candidate for AMP-based anti-infective orthopedic biomaterials.

Postural control imbalance in individuals with a minor lower extremity amputation: A scoping review.

X‐ray excited luminescence chemical imaging (XELCI) and associated sensor surfaces are designed to noninvasively study, detect, and monitor local chemistry at the surface of modified implanted medical devices during infection. Implants are coated with polymer films containing scintillators and pH indicator dyes that together generate a pH‐dependent luminescence when irradiated by X‐rays. A focused X‐ray beam provides high spatial resolution, while the pH indicator provides chemical sensitivity. A live rabbit pH‐imaging study on a scintillator‐coated implanted titanium plate evaluates the sensor performance with and without Staphylococcus aureus infection and biocompatibility through long‐term histological examinations. 5000 cfu are sufficient to cause infection without fatality. XELCI images clearly shows dye and reference regions in live rabbits; no leaching is evident in titanium plates coated with polyethylene glycol (PEG) hydrogel up to 10 days, although dye leached fromvinyl‐PEG film‐coated implants. No toxicity is evident, and pH sensors remained stable after up to 3 months postimplantation. In these preliminary studies, acidosis is not observed in either infected or control legs in vivo or postmortem. The results demonstrate the feasibility of imaging pH and provide insights for optimizing the sensor and the imaging modality for subsequent studies on pH changes on implants during infection.

Today, traumatology and orthopedics are among the most important areas of medical care. Pirogov, Turner, Vreden, Chaklin, and Rozanov are traditionally recognized as the founders of these fields. Another figure who dedicated his life to the study of traumatology and orthopedics and deserves inclusion in this list is Nikolay N. Priorov. This work aims to present the most comprehensive information on the professional path of Academician Priorov as one of the founders of Russian traumatology and orthopedics, in honor of the 140th anniversary of his birth. The methodological foundation of the article includes a systemic approach based on the principles of historicism, objectivity, and scientific rigor, as well as general scientific methods (such as generalization, analysis, synthesis, and induction). The study is based on archival documents, scientific data, books, and articles. Priorov achieved outstanding success as a teacher, scientist, and physician. He held the titles of Doctor of Medical Sciences, Professor, Head of the Department of Traumatology and Orthopedics at several institutions, Academician of the USSR Academy of Medical Sciences, Honored Scientist of the Russian Soviet Federative Socialist Republic, Deputy Minister of Health of the USSR, founder of the Moscow and All-Union Societies of Traumatologists and Orthopedists, and a member of several international medical societies. One of his major achievements was the establishment of the Institute of Prosthetics and Treatment, which was later named after him. For 40 years, Academician Priorov served as its permanent director of this institution. Today, it is known as the Priorov National Medical Research Center for Traumatology and Orthopedics under the Ministry of Health of Russia. Of particular note is Priorov’s role as Chief Surgeon in the hospital directorates of the People’s Commissariat of Health during the Great Patriotic War. His work focused on organizing the treatment and rehabilitation of the wounded and disabled, with an emphasis on providing prosthetics and orthopedic devices as essential components of comprehensive rehabilitation. His experience in military medicine remains highly relevant today. For his contributions, Priorov was awarded two Orders of Lenin, the Order of the Red Star, the Order of the Badge of Honor, and numerous medals. This article provides new biographical details about Priorov, including his expeditions to Novaya Zemlya, Vaygach Island, and Yugorsky Shar, as well as the history of the foundation of the Central Institute of Traumatology and Orthopedics. This feature sets it apart from previous publications devoted to this outstanding scientist.

Previous studies have established that the preservation of the volume of residual hard tooth tissues (ferrule effect) affects the resistance of the restored structure to the physical and mechanical characteristics of the restoration. Existing methods for determining the volume of hard tissue defects after endodontic intervention are time-consuming and require additional laboratory steps, which complicates their use in clinical settings. Today, determining the extent of destruction of hard tooth tissues is one of the decisive indicators when choosing a direct or indirect treatment method. This is due to the fact that it is based on a differentiated approach in combination with orthopedic devices as a measure of prevention of destruction of the crown part of the teeth. This gives grounds to consider the problem of determining the volume of the ferrule as relevant. To evaluate and develop the use of a method for determining residual tooth tissue volumes and hard tooth tissue defect volumes after endodontic intervention. In order to determine the volumes of residual hard dental tissues and the volumes of hard dental tissue defects for each group, adequate geometric models were used. Using the constructed models, mathematical calculations were performed based on their linear dimensions. The results we have substantiated the feasibility of using software to calculate the volumes of residual hard tissues of the tooth (dental ferrule) in order to adequately select the method of restoration of hard tissue defects after endodontic treatment. The application implements the method described in for calculating crown volumes for each group of teeth, as well as the method proposed in this work for calculating the volumes of residual hard tooth tissues. The value of the volumetric index of the dental ferrule calculated by the software application can serve as an additional decision-making criterion when choosing the optimal method of restoring defects in the hard tissues of the tooth after endodontic intervention. Using software, we have proposed a method for calculating the volumes of residual hard tooth tissues after endodontic intervention in clinical conditions, which allows us to improve the diagnostic process in the presence of defects in hard tooth tissues after endodontic intervention for the selection of restoration methods. The advantages of this approach over others are the possibility of obtaining results in clinical conditions, the low cost of software, and the small error of the result. The software application has an intuitive graphical interface for entering input morphometric data, does not require any special additional skills from the user, and has no restrictions for use in clinical settings. The volume of residual hard tooth tissues calculated using the application, and in the case of morphometric data of the dental crown, also the volume index of the dental ferrule, can serve as an additional decision-making criterion when choosing the optimal method for restoring defects in hard tooth tissues after endodontic intervention. Prospects for further research the choice of the method of treatment of defects in the hard tissues of teeth after endodontic intervention is not defined in a single protocol and requires further careful study with new experimental developments of world leaders in dentistry.