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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_14 | Pages 22 - 22
1 Dec 2019
Veloso M Bernaus M Angles F Gómez L Cubillos YL Soto S Font-Vizcarra L
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Aim. To evaluate bacterial adhesion and biofilm formation to metallic cerclage wire versus polymer cerclage system (SuperCable®). Methods. Experimental in vitro study to evaluate quantitative bacterial adherence to different cerclage wire materials. Two types of cerclage wires were compared: a metallic versus a polymer based wire (SuperCable®). A two-centimeter cerclage wire piece of each material was included in 2 mL of tryptic soy broth (TSB) culture media, inoculated with 10 microliters of a 0.5 McFarland of a Staphylococcus epidermidis strain and cultivated at 37°C during 2h for adhesion and 48h for biofilm formation. After this time, the cerclages were washed using a 1% phosphate buffered saline (PBS) and sonicated in new culture medium. After sonication, dilutions of each culture were spread in TSB agar and incubated 37°C during 24h. The number of colonies were counted and the cfu/cm2 was calculated. Results. There were no differences in the number of colonies counted at 2 hours. At 48 hours, the polymer cerclage system showed a clinically and statistically reduction of 95.2% in the biofilm formation of S. epidermidis. The highest bacterial counts were observed in metallic cerclages after 48h. Conclusion. In in vitro conditions, the polymer cerclage system may offer decreased biofilm formation compared with metallic cerclage wires. However, there are many other factors in in vivo conditions that could play a role in bacterial adhesion to cerclage wires. Further research is needed in order to recommend the use of polymer cerclage systems for septic revision surgery


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 80 - 80
1 Jan 2016
Cho C Murakami T Sawae Y
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Ultra-high molecular weight polyethylene (UHMWPE) is the sole polymeric material currently used for weight-bearing surfaces in total joint arthroplasty. However, the wear phenomenon of UHMWPE components in knee and hip prostheses after total joint arthroplasty is one of the major restriction factors on the longevity of these implants. In order to minimize the wear of UHMWPE and to improve the longevity of artificial joints, it is necessary to clarify the factors influencing the wear mechanism of UHMWPE. In the microscopic surface observation of the virgin knee prosthesis with anatomical design, various grades of microscopic surface scratches and defects caused by machining and surface finishing processes during manufacture of the component were observed on the surface of the metallic femoral component [Fig. 1] (C. Cho et al, 2009), although the overall surface were finished at smoother level. It is thought that certain levels of the microscopic surface asperities caused by these surface damages in the metallic femoral component might contribute to increasing and/or accelerating wear of the UHMWPE tibial insert. Therefore, it is necessary to clarify quantitatively the influence of the microscopic surface asperities of the metallic components in virgin artificial joints on the wear of UHMWPE components. The primary purpose of this study was to investigate the influence of the microscopic surface asperities of the virgin metallic femoral component on the wear of the UHMWPE tibial insert in the virgin knee prosthesis. In this study, the authors focused on the three-dimensional shape of the microscopic surface asperities as a factor influencing the wear mechanism of the UHMWPE tibial insert. The 3D microscopic surface profile measurement of the virgin metallic femoral component using a laser microscope and reproduction of the femoral component surface using 3D CAD software were performed [Fig. 2] in order to produce idealized 3D finite element models of the microscopic surface asperity of the femoral component based on actual measurement data. Elasto-plastic finite element contact analyses between idealized microscopic surface asperities and UHMWPE were also performed in order to investigate the influence of the three-dimensional shape of the microscopic surface asperities of the virgin metallic femoral component on the wear of the UHMWPE tibial insert. The analytical findings of this study suggest that the aspect ratio and shape ratio [Fig. 3] of the microscopic surface asperity of the virgin metallic femoral component have an important influence on increasing and/or accelerating wear of the UHMWPE tibial insert


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 53 - 53
1 Feb 2020
Cubillos PO Santos VD Pizzolatti ALA De Mello Roesler CR
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Introduction. The release of metallic debris can promote many adverse tissue reactions, as metallosis, necrosis, pseudotumors and osteolysis . 1–3. This debris is mainly generated by the fretting-corrosion mechanism due to the geometric difference in the head-stem interface . 4. Retrieval and in silico analysis showed the roughness of the stem-head interface appears to play an important role in the volume of material lost and THA failure . 5–7. The technical standard ISO 7206-2 recommends the measurement of average roughness (Ra) and max height of the profile (Rz) to control the quality of the surface finish of articulating surfaces on THA implants. However, despite the importance of the trunnion roughness, there is no specific requirement for this variable on the referred technical standard. The present study carried out a surface finish analysis of the trunnion of hip stems from five distinct manufacturers. Methods. Four stems (n = 4) from five (5) distinct manufacturers (A, B, C, D, and E) were used to evaluate the roughness of the trunnion. All the stems are similar to the classical Exeter stem design, with a 12/14 taper and a polished body surface. The roughness of trunnions was evaluated according to ISO 4287 and ISO 13565-2. The total assessment length was 4.8 mm with 0.8 mm cut-off. The first and last 8.33% of assessment length were not considered. The measurements of all samples were made in a rugosimeter with 2 µm feeler ITP (Völklingen, Germany), the velocity of 0.5 mm.s. -1. , and a force of 1.5 mN. The calibration was made at 20 ºC and relative humidity at 50%. The Kruskal Wallis with post hoc Nemenyi test was used to evaluate the difference of Ra among the manufacturers. The confidence level was set at 5%. Results and Discussion. The analysis of surface finish revealed different roughness among the manufactures (p < 0.005), with Ra between 0.061 µm to 3.184 µm and Rz varying of 0.41 µm to 12.69 µm. The manufacturers A and E had a Ra (2.587±0.050 µm and 3.146±0.031µm) of the trunnion similar to founded by Panagiotidou et al (2013). Within such range, the trunnion has shown a high presence of pit . 8. The manufacturer C, on the other hand, had the best surface finish of the trunnion (Ra = 0.069±0.010 µm and Rz = 0.505 ± 0.076 µm). This more smooth surface might increase the taper strength, reduce the shear stress and the susceptibility to the fretting-corrosion damage . 4,8. . Conclusion. The results were worrying because there is great variability of roughness among the manufacturers with the occurrence of trunnions with roughness too high. Nevertheless, the ISO technical standard does not recommend any procedure or minimum parameters acceptable for the surface finish of the trunnion. The revision of ISO 7206-2 would guarantee better control of trunnion roughness to reduce the amount of metallic debris and increase the safety of THA implants. Additional research is needed to determine a target value for this variable. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 155 - 155
1 Jan 2016
Ghosh R Paul S Rubel YSA Paul A Saha D
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Introduction. Long-term success of the cementless acetabular component has been depends on amount of bone ingrowth around porous coated surface of the implant, which is mainly depends on primary stability, i.e. amount of micromotion at the implant-bone interface. The accurate positioning of the uncemented acetabular component and amount of interference fit (press-fit) at the rim of the acetabulum are necessary to reduce the implant-bone micromotion and that can be enhancing the bone ingrowth around the uncemented acetabular component. However, the effect of implant orientations and amount of press-fit on implant-bone micromotion around uncemented acetabular component has been relatively under investigated. The aim of the study is to identify the effect of acetabular component orientation on implant-bone relative micromotion around cementless metallic acetabular component. Materials and Method. Three-dimensional finite element (FE) model of the intact and implanted pelvises were developed using CT-scan data [1]. Five implanted pelvises model, having fixed antiversion angle (25°) and different acetabular inclination angle (30°, 35°, 40°, 45° and 50°), were generated in order to understand the effect of implant orientation on implant-bone micromotion around uncemented metallic acetabular component. The CoCrMo alloy was chosen for the implant material, having 54 mm outer diameter and 48 mm bearing diameter [1]. Heterogeneous cancellous bone material properties were assigned using CT-scan data and power law relationship [1], whereas, the cortical bone was assumed homogeneous and isotropic [1]. In the implanted pelvises models, 1 mm diametric press-fit was simulated between the rim of the implant and surrounding bone. Six nodded surface-to-surface contact elements with coefficient of friction of 0.5 were assigned at the remaining portion of the implant–bone interface [1]. Twenty-one muscle forces and hip-joint forces corresponds to peak hip-joint force of a normal walking cycle (13%) were used for the applied loading condition. Fixed constrained was prescribed at the sacroiliac joint and pubis-symphysis [1]. A submodelling technique was implemented, in order to get more accurate result around implant-bone interface [1]. Results and Discussions. The peak implant-bone sliding interfacial micromotion was observed around 75 microns around superior and supero-posterior regions of the acetabulum, whereas, micromotion was below 50 microns around other regions (area). As compared to other regions, less implant-bone micromotions were observed at the central region of the acetabulum and anterior part of the acetabulum, where micromotions were varied in the range between 5 microns to 30 microns. Although, the generated peak implant-bone sliding micromotion around the uncemented acetabulum was not vary notably due to change in inclination angle of the acetabular component, changes in patterns of implant-bone micromotions were observed and as shown [Fig.1]. Results of the present study indicated that the positioning of the uncemented acetabular component have influence on patterns of implant-bone micromotion and that might have influence on bone ingrowth and long-term success of uncemented acetabular component


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 583 - 583
1 Dec 2013
Weisenburger J Garvin K Haider H
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Testing wear durability of UHMWPE joint replacement bearings under abrasive conditions (mimicking in vivo conditions when metallic components become scratched from bone or cement debris) is useful in screening new bearing materials or alternative processing methods. Adding third body particle debris in testing brings the complications of minimal (if any) increase in wear with particles lodging into the plastic bearings potentially causing unknown errors for gravimetric wear measurements. Alternatively, testing those bearings against already scratched metallic components may provide a cleaner route without such complications. This requires a method to reproducibly create scratches resembling the damage seen on retrievals. This study introduces such a method, and investigates wear of UHMWPE bearings against metallic femoral hip components that have been intentionally scratched. In this technique, femoral hip heads were pressed and sunk into a bed of abrasive beads under a known load (712N, one body weight), and this created longitudinal scratches. Latitudinal scratches were generated by rotating the sunken femoral heads ± 90° about their polar axis while under the same load. This process (pressing into the abrasive beads and then turning ± 90°) was repeated 10 times on each femoral component which resulted in thousands of random scratch patterns, but with statistically repeatable overall severity and similar visually to retrievals (Fig. 1). We then evaluated the technique through a hip wear study. Twelve UHMWPE liners (40 mm I.D.) were tested against CoCrMo femoral heads on a 12-station hip simulator (AMTI). Liners were three materials: a) Three conventional (GUR1020, gamma-sterilized 3.5 Mrad), b) Three highly cross-linked (HXL) (GUR1020, 10 Mrad, annealed, EtO-sterilized, artificially aged), and c) Six HXL w/vitamin-E (GUR1020, 12 Mrad, annealed, EtO-sterilized, aged). The test comprised three phases. Phase-I: standard clean (non-abrasive, non-scratched) test for 5 Mc; Phase-II: Pulverized PMMA was added to serum at 700 mg/L (to introduce abrasive conditions); however, effects were minimal after 2 Mc (7 Mc total). Phase-III: Femoral heads were scratched using our method. Phase-III lasted for 1 Mc, for a testing total of 8 Mc (ISO-14242-1 waveforms). All specimens were lubricated with bovine serum (37°C, 30g/L protein). Plastic liners were cleaned and weighed at standard intervals, and wear was corrected with active loaded soak controls. The wear results are shown in Fig. 2. The conventional liners showed the highest wear (Phase-I: 55.7 ± 3.00 mg/Mc, Phase-II: 49.2 ± 0.520 mg/Mc, Phase-III: 124 ± 28.9 mg/Mc) while HXL liners displayed much lower wear (Phase-I: 2.58 ± 0.969 mg/Mc; Phase-II: 4.93 ± 1.22 mg/Mc; Phase-III: 9.92 ± 4.64 mg/Mc). Vitamin-E HXL liners also showed very low wear (Phase-I: 5.97 ± 0.50 mg/Mc, Phase-II: 8.89 ± 1.40 mg/Mc, Phase-III: 11.9 ± 2.70 mg/Mc). Addition of the PMMA powder during Phase-II increased liner wear, but the surfaces did not appear damaged like retrievals. Wear rates between Phase-I and Phase-III doubled due to scratching the femoral heads for all material types, a statistically significant increase (p < 0.05). Our results confirm that the scratching procedure successfully created a severe wear situation for the bearings. Future work will involve abrasive testing on knee components to determine if the method is successful there too


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 31 - 31
1 Jul 2020
Jahr H Pavanram P Li Y Lietaert K Kubo Y Weinans H Zhou J Pufe T Zadpoor A
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Biodegradable metals as orthopaedic implant materials receive substantial scientific and clinical interest. Marketed cardiovascular products confirm good biocompatibility of iron. Solid iron biodegrades slowly in vivo and has got supra-physiological mechanical properties as compared to bone and porous implants can be optimized for specific orthopaedic applications. We used Direct Metal Printing (DMP)3 to additively manufacture (AM) scaffolds of pure iron with fine-tuned bone-mimetic mechanical properties and improved degradation behavior to characterize their biocompatibility under static and dynamic 3D culture conditions using a spectrum of different cell types.

Atomized iron powder was used to manufacture scaffolds with a repetitive diamond unit cell design on a ProX DMP 320 (Layerwise/3D Systems, Belgium). Mechanical characterization (Instron machine with a 10kN load cell, ISO 13314: 2011), degradation behavior under static and dynamic conditions (37ºC, 5% CO2 and 20% O2) for up of 28 days, with μCT as well as SEM/energy-dispersive X-ray spectroscopy (EDS) (SEM, JSM-IT100, JEOL) monitoring under in vivo-like conditions. Biocompatibility was comprehensively evaluated using a broader spectrum of human cells according to ISO 10993 guidelines, with topographically identical titanium (Ti-6Al-4V, Ti64) specimen as reference. Cytotoxicity was analyzed by two-way ANOVA and post-hoc Tukey's multiple comparisons test (α = 0.05).

By μCT, as-built strut size (420 ± 4 μm) and porosity of 64% ± 0.2% were compared to design values (400 μm and 67%, respectively). After 28 days of biodegradation scaffolds showed a 3.1% weight reduction after cleaning, while pH-values of simulated body fluids (r-SBF) increased from 7.4 to 7.8. Mechanical properties of scaffolds (E = 1600–1800 MPa) were still within the range for trabecular bone, then. At all tested time points, close to 100% biocompatibility was shown with identically designed titanium (Ti64) controls (level 0 cytotoxicity). Iron scaffolds revealed a similar cytotoxicity with L929 cells throughout the study, but MG-63 or HUVEC cells revealed a reduced viability of 75% and 60%, respectively, already after 24h and a further decreased survival rate of 50% and 35% after 72h. Static and dynamic cultures revealed different and cell type-specific cytotoxicity profiles. Quantitative assays were confirmed by semi-quantitative cell staining in direct contact to iron and morphological differences were evident in comparison to Ti64 controls.

This first report confirms that DMP allows accurate control of interconnectivity and topology of iron scaffold structures. While microstructure and chemical composition influence degradation behavior - so does topology and environmental in vitro conditions during degradation. While porous magnesium corrodes too fast to keep pace with bone remodeling rates, our porous and micro-structured design just holds tremendous potential to optimize the degradation speed of iron for application-specific orthopaedic implants. Surprisingly, the biological evaluation of pure iron scaffolds appears to largely depend on the culture model and cell type. Pure iron may not yet be an ideal surface for osteoblast- or endothelial-like cells in static cultures. We are currently studying appropriate coatings and in vivo-like dynamic culture systems to better predict in vivo biocompatibility.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 64 - 64
1 Apr 2018
DesJardins J Bales C Helms S
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Introduction

The accumulation of proteins and bacteria on implant surfaces is a critical concern in the biomedical field, especially with respect to the potential of biofilm formation on implant surfaces. Material surface wettability is often used as a predictor of potential colonization of specific bacterial strains. Surface roughness has also been shown to have a strong relationship with biofilm formation, as rougher surfaces tend to have a stronger affinity to harbor bacterial colonies. The modification of implant surfaces to impart a biofilm resistant layer can come at the expense of increasing surface roughness however, and it is therefore important to determine how the variables of wettability and roughness are affected by any new surface coating technologies. In the current work, a novel CoBlast (C) process that impregnates alumina (A) at 50 μm grit (5) or 90 μm grit (9) sizes, with the possible addition of polytetrafluoroethylene (P) onto titanium surfaces, combined with a plasma coating process called BioDep, that coats the surface with chitosan (X) with the possible addition of vancomycin (V), were evaluated for wettability and surface roughness to determine their potential as biofilm resistant treatments on implants.

Materials and Methods

N=65 titanium alloy samples (n=5 for 13 sample modification types as described above and in the figure legends below) were analyzed for surface roughness and wettability. Following cleaning in ethanol, roughness testing (Ra, Rq, Rt and Rz, Wyko NT-2000 optical profilometer @ 28.7× magnification, FOV of 164×215 μm) at 5 different surface locations per specimen, and contact angle analysis was performed (2 μL water drops, KRUSS EasyDrop). Statistical differences between groups was determined using ANOVA.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 136 - 136
1 Jan 2016
Gonzalez FQ Reimeringer M Nuno N
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Introduction

After arthroplasty, stress shielding and high shear stresses at the bone-implant interface are common problems of load bearing implants (e.g. hip prostheses). Stiff implants cause stress shielding, which is thought to contribute to bone resorption1. High shear stresses, originated by low-stiffness implants, have been related to pain and interfacial micro-movements², prohibiting adequate implant initial fixation.

A non-homogeneous distribution of mechanical properties within the implant could reduce the stress shielding and interfacial shear stresses3. Such an implant is called “functionally graded implant” (FGI). FGI require porous materials with well-controlled micro-architecture, which can now be obtained with new additive manufacturing technologies (e.g. Electron Beam Melting).

Finite element (FE) simulations in ANSYS-v14.5 are used to develop an optimization methodology to design a hip FGI.

Methodology

A coronal cut was performed on a femur model (Sawbones®) with an implanted Profemur®TL (Wright Medical Inc.) stem to obtain the 2D-geometry for FE simulations.

The central part of the FGI stem was made porous, the neck and inferior tip were solid. Ti6Al4V elastic material was assumed (E=120 GPa, v=0.3). Three bone qualities were considered for the optimization: poor (E=6GPa; v=0.3); good (E=12GPa; v=0.3); excellent (E=30GPa; v=0.3).

The structure of bone evolves to maintain a reasonable level of the strains. Similarly in the proposed algorithm, the strut sections of the porous material evolve to keep stresses (proportional to strains) at a reasonable level. Starting with a very small strut section, resulting in an almost zero-rigidity stem, strut sections are increased or decreased as a function of the stresses they support. This is done incrementally, until force values corresponding to normal walking of an 80 kg person (1867 N)4 are reached. Force direction was vertical and no action of the abductors was considered, to analyze the worst case scenario. The optimized FGI microstructure is defined by the strut diameter distributions. Since the distance between struts remain constant, variations in strut diameters result in variations in density.

Optimized FGI porous structure was compared for the three bone qualities considered and with a solid stem in terms of bone stresses.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 109 - 109
1 Dec 2013
Kurdziel M Maerz T Baker E Salisbury M Kaplan L Baker K
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Introduction:

Unicompartmental knee arthroplasty (UKA) has been used in the past decades to treat progressive cartilage degeneration in a single compartment. Concern has been raised over the rate of revision procedures for polyethylene wear and osteoarthritic progression into the adjacent compartment. Few studies have examined the pathology of cartilage degeneration in the setting of UKA. This study aims to investigate the viability of knee chondrocytes introduced to high and low concentrations of orthopaedic wear debris particulate.

Methods:

Normal human articular chondrocytes (nHAC-Kn) were expanded in DMEM/F12 containing 10% FBS, 1% Penicillin/Streptomycin (Pen/Strp), and 50 μg/mL ascorbic acid (Asc). 24 hours prior to the start of the experiment, cells were seeded on 96-well plates at a density of 3500 cells/cm2 and exposed to DMEM/F12 containing 5% FBS, 1% Pen/Strp, and 50 μg/mL Asc. Particles (equivalent circle diameter range: 0.2–7 μm) at a low dose of 100: 1 (particles: cells) and high dose 1000: 1 (particles: cells) were introduced to treatment wells (n = 6). Control wells (n = 6) contained particles with no cells.

Treatment groups included high and low doses of TiAl6V4 alloy, 316L Stainless Steel, and Co-Cr-Mo alloy. At days 1, 3, 5, and 7, cells were assayed with a 3-(4,5-Dimethylthiazol-2-yl)-2,5-dyphenyltetrazolium bromide (MTT) assay for determination of cell viability. Light microscopy was performed at each timepoint to assess change in cell morphology.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1168 - 1172
1 Jun 2021
Iliadis AD Wright J Stoddart MT Goodier WD Calder P

Aims. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited regarding outcomes and potential problems. We report on our early experience and raise awareness for the potential of adverse effects from this device. Methods. This is a retrospective review of prospective data collected on all patients treated in our institution using this implant. We report the demographics, nail accuracy, reliability, consolidation index, and cases where concerning clinical and radiological findings were encountered. There were 14 STRYDE nails implanted in nine patients (three male and six female) between June 2019 and September 2020. Mean age at surgery was 33 years (14 to 65). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. Results. At the time of reporting, eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localized pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusion. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered concerning clinical and radiological findings in several patients. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally. Cite this article: Bone Joint J 2021;103-B(6):1168–1172


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_10 | Pages 79 - 79
1 Oct 2022
Bernaus M Cubillos YL Soto S Bermúdez A Calero JA Torres D Veloso M Font-Vizcarra L
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Aim. To evaluate the efficiency of pulse lavage combined with electrical fields to remove biofilm from a metallic surface. Method. Using a 12-well culture plate designed for the application of electrical fields, strains of S. epidermidis were incubated at each well for 24 hours at 37ºC. After incubation, supernatant culture medium was removed, and each well was filled with 3ml of normal saline. Six different models were compared: a) control, b) low-pressure pulse lavage, c) high-pressure pulse lavage, d) pulsed electrical fields, e) low-pressure pulse lavage in combination with pulsed electrical fields, and f) high-pressure pulse lavage in combination with pulsed electrical fields. In all cases, exposure time was set to 25 seconds. In the electrical field models, 50 pulses were applied. After exposure, each bottom electrode was scraped carefully to release adhered bacteria. Subsequently, different dilutions of biofilm removed were spread onto Müller Hinton agar plates and incubated for 24h at 37 ºC, and colony-forming units (CFU) per milliliters were counted. Bacterial counts were then compared to the control model. Results. High-pressure pulse lavage combined with pulsed electrical fields showed the greatest biofilm removal with reductions of up to 11.9 logarithms when compared to the control group. The lowest reduction was achieved by low-pressure pulsed lavage (4.7 logs). All reductions showed statistically significant differences. Conclusion. The results of our comparative study between different models demonstrates high reduction rates for biofilm removal. Further in vivo studies are needed to evaluate the capacity of the combination of high-pressure pulse lavage with pulsed electrical fields in removing bacterial biofilm in real conditions


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_10 | Pages 8 - 8
1 Jun 2023
Harris PC Lacey S Perdomo A Ramsay G
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Introduction. The vast majority of orthopaedic surgeons use C-arm fluoroscopy in the operating theatre when building a circular external fixator. In the absence of previous research in this area, we hypothesised that the surgeon who builds a circular external fixator is exposed to a greater amount of radiation purely as a result of the presence of the metallic fixator in the x-ray beam. The aim of our study therefore was to investigate how the presence of a circular external fixator affects the radiation dose to the surgeon and the surgical assistant. Materials & Methods. A simulated environment was created using a radiolucent operating table, an acrylic lower limb phantom (below knee segment), various configurations of metalic circular external fixation, and a standard size C-arm image intensifier. The variables investigated were 1. the amount of metal in the beam 2. the orientation of the beam (PA vertical vs lateral) 3. the horizonal distance of the person from the beam (surgeon vs assistant) and 4. the vertical distance of the various body parts from the beam (e.g. thyroid, groin). In terms of radiation dose, we recorded two things : 1. the dose produced by the image intensifier 2. the dose rate at standardised positions in the operating theatre. The latter was done using a solid-state survey sensor. These positions represented both where the surgeon and surgical assistant typically stand plus the heights of their various body regions relative to the operating table. Results. The effect of the presence of the circular external fixator : all frame constructs tested resulted in a statistically significant greater radiation dose both produced by the image intensifier and received by the surgical team. The effect of the beam orientation : the PA (vertical) orientation resulted in a statistically significant greater radiation dose for the surgeon than did the lateral orientation, but made no difference for the assistant. The effect of horizontal distance from the beam : unsurprisingly, the surgeon (who was closer to the beam) received a statistically significant greater radiation dose than the assistant. The effect of vertical distance from the beam : for the surgeon, the dose received was highest at the level of the phantom leg / frame, whilst for the assistant there was no statistically significant difference for any level. Conclusions. To our knowledge, this is the first study investigating the radiation dose rate to the orthopaedic surgeon when building a circular external fixator. We found that the surgeon does indeed receive a ‘double whammy’ because the image intensifier puts out a greater amount of radiation plus the metalic frame scatters more of the x-ray beam. Whilst the amounts are relatively small, we think that it's important to quantify doses that orthopaedic surgeons receive to ensure optimal radiation practices


Bone & Joint Research
Vol. 10, Issue 7 | Pages 425 - 436
16 Jul 2021
Frommer A Roedl R Gosheger G Hasselmann J Fuest C Toporowski G Laufer A Tretow H Schulze M Vogt B

Aims. This study aims to enhance understanding of clinical and radiological consequences and involved mechanisms that led to corrosion of the Precice Stryde (Stryde) intramedullary lengthening nail in the post market surveillance era of the device. Between 2018 and 2021 more than 2,000 Stryde nails have been implanted worldwide. However, the outcome of treatment with the Stryde system is insufficiently reported. Methods. This is a retrospective single-centre study analyzing outcome of 57 consecutive lengthening procedures performed with the Stryde nail at the authors’ institution from February 2019 until November 2020. Macro- and microscopic metallographic analysis of four retrieved nails was conducted. To investigate observed corrosion at telescoping junction, scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDX) were performed. Results. Adjacent to the nail’s telescoping junction, osteolytic changes were observed in bi-planar radiographs of 20/57 segments (35%) after a mean of 9.5 months (95% confidence interval 7.2 to 11.9) after surgery. A total of 8/20 patients with osseous alterations (40%) reported rest and ambulation pain of the lengthened segment during consolidation. So far, 24 Stryde nails were retrieved and in 20 (83%) macroscopic corrosion was observed at the nail’s telescoping junction. Before implant removal 11/20 radiographs (55%) of lengthened segments with these 20 nails revealed osteolysis. Implant retrieval analysis by means of SEM showed pitting and crevice corrosion. EDX detected chromium as the main metallic element of corrosion. Conclusion. Patients are exposed to the risk of implant-related osteolysis of unclear short- and long-term clinical consequences. The authors advocate in favour of an early implant removal after osseous consolidation. Cite this article: Bone Joint Res 2021;10(7):425–436


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 85 - 85
1 Dec 2022
Fleet C McNeil D Trenholm JAI Johnson JA Athwal G
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Massive irreparable rotator cuff tears often lead to superior migration of the humeral head, which can markedly impair glenohumeral kinematics and function. Although treatments currently exist for treating such pathology, no clear choice exists for the middle-aged patient demographic. Therefore, a metallic subacromial implant was developed for the purpose of restoring normal glenohumeral kinematics and function. The objective of this study was to determine this implant's ability in restoring normal humeral head position. It was hypothesized that (1) the implant would restore near normal humeral head position and (2) the implant shape could be optimized to improve restoration of the normal humeral head position. A titanium implant was designed and 3D printed. It consisted of four design variables that varied in both implant thickness (5mm and 8mm) and curvature of the humeral articulating surface (high constraint and low constraint. To assess these different designs, these implants were sequentially assessed in a cadaver-based biomechanical testing protocol. Eight cadaver specimens (64 ± 13 years old) were loaded at 0, 30, and 60 degrees of glenohumeral abduction using a previously developed shoulder simulator. An 80N load was equally distributed across all three deltoid heads while a 10N load was applied to each rotator cuff muscle. Testing states included a fully intact rotator cuff state, a posterosuperior massive rotator cuff tear state (cuff deficient state), and the four implant designs. An optical tracking system (Northern Digital, Ontario, Canada) was used to record the translation of the humeral head relative to the glenoid in both superior-inferior and anterior-posterior directions. Superior-Inferior Translation. The creation of a posterosuperior massive rotator cuff tear resulted in significant superior translation of the humeral head relative to the intact cuff state (P=0.016). No significant differences were observed between each implant design and the intact cuff state as all implants decreased the superior migration of the humeral head that was observed in the cuff deficient state. On average, the 5mm low and high constraint implant models were most effective at restoring normal humeral head position to that of the intact cuff state (-1.3 ± 2.0mm, P=0.223; and −1.5 ± 2.3mm, P=0.928 respectively). Anterior-Posterior Translation. No significant differences were observed across all test states for anterior-posterior translation of the humeral head. The cuff deficient on average resulted in posterior translation of the humeral head, however, this was not statistically significant (P=0.128). Both low and high constraint implant designs were found to be most effective at restoring humeral head position to that of the intact cuff state, on average resulting in a small anterior offset (5mm high constraint: 2.0 ± 4.7mm, P=1.000; 8mm high constraint: 1.6 ± 4.9mm, P=1.000). The 5mm high constraint implant was most effective in restoring normal humeral head position in both the superior-inferior and anterior-posterior directions. The results from this study suggest the implant may be an effective treatment for restoring normal glenohumeral kinematics and function in patients with massive irreparable rotator cuff tears. Future studies are needed to address the mechanical efficiency related to arm abduction which is a significant issue related to patient outcomes


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_22 | Pages 64 - 64
1 Dec 2017
Ravn C Ferreira IS Maiolo E Overgaard S Trampuz A
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Aim. The primary aim of this in vitro study was to test the efficacy of daptomycin to eradicate staphylococcal biofilms on various orthopedic implant surfaces and materials. The secondary aim was to quantitatively estimate the formation of staphylococcal biofilm on various implant materials with different surface properties. Method. We tested six clinically important biomaterials: cobalt chrome alloy, pure titanium, grid-blasted titanium, porous plasma-coated titanium with/without hydroxyapatite, and polyethylene. Two laboratory strains of bacteria commonly causing PJI were used, namely Staphylococcus aureus* and Staphylococcus epidermidis*. After overnight incubation with biofilm formation, the test samples were washed and individually exposed to increasing daptomycin concentrations (4–256 mg/l) during 24-hours. Samples were subsequently sonicated in order to detect dislodged biofilm bacteria on blood agar plates by viable growth and transferred to a microcalorimeter*** for real-time measurement of growth related heat flow during 24-h incubation. Minimal biofilm eradication concentration (MBEC) was determined as the lowest concentration of antibiotic required to eradicate the biofilm bacteria on the sample. The time to detection expressed as the heat flow >50 µW (TTD-50) indirectly quantifies the initial amount of biofilm bacteria, with a shorter TTD-50 representing a larger amount of bacteria. Results. MBEC of S. aureus biofilm on smooth metallic surfaces (median 6 mg/l, range 4–8 mg/l) was significantly lower than the rough/porous metallic surfaces (median 128 mg/l, range 32–256 mg/l; p<0.001). Variations of MBEC in experiments with S. epidermidis biofilms on test samples with smooth or rough/porous surface was found non-significant (p=0.25). Mean TTD-50 (±SD) of S. aureus biofilms on rough/porous metallic samples (2.3 ±1.1 hours) was significantly lower than smooth metallic samples (6.7 ±0.4 hours, p<0.001) and polyethylene (5.3 ±0.5 hours, p<0.001). Mean TTD-50 with S. epidermidis biofilm on smooth metals (3.9 ± 1.0 hours) was also significantly higher than their rough/porous counterparts (2.0 ± 1.0 hours, p=0.010). Conclusions. Growth of biofilm bacteria on orthopedic materials are variably influenced by exposure to the potent antimicrobial effect of high-dose daptomycin. In this study, the main factor decisively influencing biofilm quantity and daptomycin susceptibility of staphylococcal biofilms was the irregular surface topography. * ATCC® 29213™. ** ATCC® 35984™. *** TAM III


The Bone & Joint Journal
Vol. 95-B, Issue 8 | Pages 1022 - 1026
1 Aug 2013
O’Neill SC Queally JM Devitt BM Doran PP O’Byrne JM

Peri-prosthetic osteolysis and subsequent aseptic loosening is the most common reason for revising total hip replacements. Wear particles originating from the prosthetic components interact with multiple cell types in the peri-prosthetic region resulting in an inflammatory process that ultimately leads to peri-prosthetic bone loss. These cells include macrophages, osteoclasts, osteoblasts and fibroblasts. The majority of research in peri-prosthetic osteolysis has concentrated on the role played by osteoclasts and macrophages. The purpose of this review is to assess the role of the osteoblast in peri-prosthetic osteolysis. In peri-prosthetic osteolysis, wear particles may affect osteoblasts and contribute to the osteolytic process by two mechanisms. First, particles and metallic ions have been shown to inhibit the osteoblast in terms of its ability to secrete mineralised bone matrix, by reducing calcium deposition, alkaline phosphatase activity and its ability to proliferate. Secondly, particles and metallic ions have been shown to stimulate osteoblasts to produce pro inflammatory mediators in vitro. In vivo, these mediators have the potential to attract pro-inflammatory cells to the peri-prosthetic area and stimulate osteoclasts to absorb bone. Further research is needed to fully define the role of the osteoblast in peri-prosthetic osteolysis and to explore its potential role as a therapeutic target in this condition. Cite this article: Bone Joint J 2013;95-B:1021–5


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 185 - 185
1 Mar 2013
Mukherjee K Pal B Gupta S
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The effects of metal ion release and wear particle debris in metal-on-metal articulation warrants an investigation of alternative material, like ceramics, as a low-wear bearing couple [1]. Short-stem resurfacing femoral implant, with a stem-tip located at the centre of the femoral head, appears to provide a better physiological load transfer within the femoral head and therefore seems to be a promising alternative to the long-stem design [2]. The objective of this study was to investigate the effect of evolutionary bone adaptation on load transfer and interfacial failure in cemented metallic and ceramic resurfacing implant. Bone geometry and material properties of 3D finite element (FE) models (intact, short-stem metallic and ceramic resurfaced femurs of 44 mm head diameter) were derived from the CT scan data. The FE models consisted of 170352 quadratic tetrahedral elements and 238111 nodes with frictional contact at the implant-cement (μ = 0.3) and stem-bone interfaces (μ = 0.4) and fully bonded cement-bone interface. Normal walking and stair climbing were considered as two different loading conditions. A time-dependant “site specific” bone remodelling simulation was based on the strain energy density and internal free surface area of bone [3]. The variable time-step was determined after each remodelling iteration. The Hoffman failure criterion was used to assess cement-bone interfacial failure. Predicted change in bone density due to bone remodelling was very much similar in both the metallic and ceramic resurfaced femurs (Fig. 1). Both the metallic and ceramic implant resulted in strain reduction in the proximal regions (Region of interest, ROI 2 and 4) and subsequent bone resorption, average bone density reduction by 72% (Fig. 1). Higher strains were generated in ROI 5 and 7, which caused bone apposition, an average increase in bone density of 145% (Fig. 1). The tensile stresses in the resurfacing implants increased with change in bone density; a maximum stress of 83 MPa and 63 MPa were observed in the ceramic and the metallic implants, respectively. The tensile stress in the cement mantle also increased with bone remodelling. Although the cement-bone interface was secure against interface debonding in the post-operative situation, calculations of Hoffman number indicated that risk of cement-bone interfacial failure was increased with peri-prosthetic bone adaptation. During the remodelling simulation, maximum tensile stress in the implant and the cement was far below its strength. However, with bone adaptation greater volume of cement mantle was exposed to higher stresses which, in-turn, resulted in greater risk of interfacial failure around the periphery of the cement mantle. Both the short-stem ceramic and metallic resurfacing component, under debonded stem-bone interface, resulted in more physiological stress distribution across the femoral head. Based on these results, short-stem ceramic resurfacing component appears to be a viable alternative to the metallic design


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_6 | Pages 4 - 4
1 May 2021
Iliadis A Wright J Stoddart M Goodier D Calder P
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Introduction. The STRYDE nail is an evolution of the PRECICE Intramedullary Limb Lengthening System, with unique features regarding its composition. It is designed for load bearing throughout treatment in order to improve patient experience and outcomes and allow for simultaneous bilateral lower limb lengthening. The literature published to date is limited with regards to both outcomes and potential issues. In this paper we report on our early experience and raise awareness for the potential of adverse effects from this device. Materials and Methods. This is a review of all patients treated in our institution using this implant. Data were prospectively recorded. We report on demographics, nail accuracy, reliability, consolidation index and cases where concerning clinical and radiological findings were encountered. Results. 14 Stryde nails were implanted in nine patients (three males and six females) between June 2019 and September 2020. Mean age at surgery was 33 years old (14–65 years old). Five patients underwent bilateral lengthening (two femoral and three tibial) and four patients unilateral femoral lengthening for multiple aetiologies. By the time of this report eight patients (13 implants) had completed lengthening. Osteolysis and periosteal reaction at the junction of the telescopic nail was evident in nine implants. Five patients experienced localised pain and swelling. Macroscopic appearances following retrieval were consistent with corrosion at the telescopic junction. Tissue histology was consistent with effects of focal metallic wear debris. Conclusions. From our early experience with this implant we have found the process of lengthening to be accurate and reliable with good regenerate formation and consolidation. Proposed advantages of early load bearing and the ability for bilateral lengthening are promising. We have, however, encountered cases with concerning clinical and radiological findings. We have elected to discontinue its use to allow further investigation into the retrieved implants and patient outcomes from users internationally


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 6 - 6
1 May 2019
Jobin C
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Severe glenoid bone loss in patients with osteoarthritis with intact rotator cuff is associated with posterior glenoid bone loss and posterior humeral subluxation. Management of severe glenoid bone loss during shoulder arthroplasty is controversial and technically challenging and options range from humeral hemiarthroplasty, anatomic shoulder replacement with glenoid bone grafting or augmented glenoid component implantation, to reverse replacement with reaming to correct version or structural bone grafting or metallic augmentation of the bone deficiency. Shoulder replacement with severe glenoid bone loss is technically challenging and characterised by higher rates of complications and revisions. Hemiarthroplasty has limited benefit for pain relief and function especially if eccentric glenoid wear exists. Bone loss with >15 degrees of retroversion likely requires version correction include bone-grafting, augmented glenoid components, or reverse total shoulder replacement. Asymmetric reaming may improve version but is limited to 15 degrees of version correction in order to preserve subchondral bone and glenoid bone vault depth. Bone-grafting of glenoid wear and defects has had mixed results with graft-related complications, periprosthetic radiolucent lines, and glenoid component failure of fixation. Implantation of an augmented wedge or step polyethylene glenoid component improves joint version while preserving subchondral bone, but is technically demanding and with minimal short term clinical follow-up. A Mayo study demonstrated roughly 50% of patients with posteriorly augmented polyethylene had radiolucent lines and 1/3 had posterior subluxation. Another wedge polyethylene design had 66% with bone ingrowth around polyethylene fins at 3 years. Long term outcomes are unknown for these new wedge augmented glenoid components. Reverse shoulder arthroplasty avoids many risks of anatomic replacement glenoid component fixation and stability but is associated with a high complication rate (15%) including neurologic and baseplate loosening and often requires structural bone grafting behind the baseplate with suboptimal outcomes or metallic augmented baseplates with limited evidence and short term outcomes. Reverse replacement with baseplate bone grafting or metal augmentation is technically challenging due to limited native glenoid bone stock available for baseplate component ingrowth and long term fixation. Failure to correct glenoid superior inclination and restore neutral version within 10 degrees increases the risks of reverse baseplate failure of fixation, pull out, and failure of reverse replacement. Reverse baseplate failure rates in patients with severe glenoid bone loss and concomitant glenoid bone grafting range from 5–11%. The minimum native glenoid bony contact with the baseplate is unknown but likely is approximately 1cm of native bone contacting a central ingrowth post and a minority (∼15–25%) of native glenoid contacting the backside of the baseplate. Failure to correct posterior bone loss can lead to retroversion of the baseplate, reduced external rotation, posterior scapular notching, and posteromedial polyethylene wear. In summary, shoulder replacement with severe glenoid bone loss is technically challenging and characterised by higher rates of complication and revision


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_16 | Pages 35 - 35
1 Oct 2014
Hananouchi T Giets E Ex J Delport H
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Optimal alignment of the acetabular cup component is crucial for good outcome of total hip arthroplasty [THA]. Increased accuracy of implant positioning may improve clinical outcome. To achieve this, patient specific instrumentation was developed. A patient-specific guide manufactured by 3D printing was designed to aid in positioning of the cup component with a pre-operatively defined anteversion and inclination angle. The guide fits perfectly on the acetabular rim. An alignment K-wire in a pre-operatively planned orientation is used as visual reference during cup implantation. Accuracy of the device was tested on 6 cadaveric specimens. During the experiment, cadavers were positioned for a THA procedure using a posterolateral approach. A normal-sized incision was made and approach used as in the conventional surgical procedure. The PSI was subsequently fitted onto the acetabular rim and secured into its unique position due to its patient specific design. The metallic pin was placed in a drill hole of the PSI. Post-operative CT image data of each acetabulum with the placed pin were transferred to Mimics and the 3D model was registered to the pre-operative one. The anteversion and inclination of the placed pin was calculated and compared to the pre-operatively planned orientation. The absolute difference in degrees was evaluated. A secondary test was carried out to assess the error during impaction while observing the alignment K-wire as a visual reference. In a laboratory setting, error during impaction with a visual reference of the K-wire was measured. Deviation from planning showed to be on average 1.04° for anteversion and 2.19° for inclination. By visually aligning the impactor with this alignment K-wire, the surgeon may achieve cup placement as pre-operatively planned. The effect of the visual alignment itself was also evaluated in a separate test-rig showing minimal deviations in the same range. The alignment validation test resulted in an average deviation of 1.2° for inclination and 1.4° for anteversion between the metallic alignment K-wire used as visual reference and the metallic K-wire impacted by the test subjects. The inter-user variability was 0.9° and 0.8° for anteversion and inclination respectively. The intra-user variability was 1.6° and 1.0° for anteversion and inclination respectively. Tests per test subject were conducted in a consecutive manner. We investigated the accuracy of two factors affecting accuracy in the cup insertion with PSI, i.e. accuracies of the errors of bony fitting and cup impaction. Since the accuracy of the major contributing factors to the overall accuracy of PSI for cup insertion with linear visual reference of a metallic K-wire was within the acceptable range of 2 to 3 degrees, we state that the PSI we have designed assists to achieve the preoperatively planned orientation of the cup and as such leads to the reduction of outliers in cup orientation. This acetabular cup orientation guide can transfer the pre-operative plan to the operating room