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Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 15 - 15
1 Dec 2013
Berahmani S Janssen D Wolfson D De Waal Malefijt M Verdonschot N
Full Access

The effect of an advanced porous surface morphology on the mechanical performance of an uncemented femoral knee prosthesis was investigated. Eighteen implants were inserted and then pushed-off from nine paired femurs (Left legs: advanced surface coating; right legs: Porocoat® surface coating as baseline). Bone mineral density (BMD) and anteroposterior dimension were measured, which both were not significantly different between groups. The insertion force was not significantly different, but push-off force was significantly higher in the advanced surface coating group (P = 0.007). BMD had direct relationship with the insertion force and push-off force (p < 0.001). The effect of surface morphology on implant alignment was very small. We suggest that the surface properties create a higher frictional resistance thereby providing a better inherent stability of implants featuring the advanced surface coating


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_IV | Pages 402 - 402
1 Apr 2004
Schaper L
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Introduction: The purpose of this paper is to present the results of a prospective study involving one stem design used in primary total hip arthroplasty with three different surface enhancements to include a simple textured geometry, a plasma sprayed coating and an hydroxyapatite (HA) coating. Methods: Between 1990 and 1994, 138 patients underwent primary THA using a simple femoral component. Thirty-eight patients received a textured geometry while 50 were implanted with a HA coated stem and 50, a plasma sprayed stem. The hips were evaluated annually both clinically and radiographically. The results are reported using the Harris Hip Score and the Engh radiographic scale to determine the level of bone ingrowth and type of fixation. Results: The average length of follow up is 8 years 11 months (range: 6 to 10 years). The average postoperative Harris Hip scores were 81.0% for the textured stems, 89.6 for the HA coated stems and 85.7 for the plasma sprayed stems. The revision rates are 13.2% for textured stems, 0% for HA and 5.4 % for plasma sprayed. Radiographic results show that fixation of the 3 surface coatings to be optimal in 100% of HA, 88.2% in plasma sprayed and 84.2% in textured. Discussion and conclusion: At this point in the study, it is obvious that the coating enhancement of choice is hydroxyapatite. The next step in this research will be to match the HA coated stems with a comparable porous coated stem of the same design for further comparison


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 90 - 90
1 Dec 2020
Gori M Giannitelli SM Papalia R Vadalà G Denaro V
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Invasive intraneural electrodes implanted in peripheral nerves are neural prosthetic devices that are exploied to control advanced neural-interfaced prostheses in human amputees. One of the main issues to be faced in chronic implants is represented by the gradual loss of functionality of such intraneural interfaces due to an electrical impedance increase caused by the progressive formation of a fibrotic capsule around the electrodes, which is originally due to a nonspecific inflammatory response called foreign body reaction (FBR).

In this in vitro work, we tested the biocompatibility and ultra-low fouling features of the synthetic coating - poly(ethylene glycol) (PEG) - compared to the organic polymer - zwitterionic sulfated poly(sulfobetaine methacrylate) (SBMA) hydrogel - to prevent or reduce the first steps of the FBR: plasma protein adsorption and cell adhesion to the interface.

Synthesis and characterization of the SBMA hydrogel was done. Preliminary biocompatibility analysis of the zwitterionic hydrogel, using hydrogel-conditioned medium, showed no cytotoxicity at all vs. control. We seeded GFP-labelled human myofibroblasts on PEG- and SBMA hydrogel-coated polyimide surfaces and evaluated their adhesion and cell viability at different time-points. Because of the high hydration, low stiffness reflecting the one of neural tissue, and ultra-low fouling characteristics of the SBMA hydrogel, this polymer showed lower myofibroblast adhesion and different cell morphology compared to adhesion controls, thereby representing a better coating than PEG for potentially mitigating the FBR.

We conclude that soft SBMA hydrogels could outperform PEG coatings in vitro as more suitable dressings of intraneural electrodes. Furthermore, such SBMA-based antifouling materials can be envisioned as long-term diffusion-based delivery systems for controlled release of anti-inflammatory and anti-fibrotic drugs in vivo.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 28 - 28
1 Mar 2017
Shin T Park S Kang K Kwon S Lim Y Moon Y Lim D
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Introduction

Recently, the combination of press-fit acetabular cup with ceramic articulation is a widely used for implanting cementless acetabular components and has been shown to provide good initial stability. However, these methods may lead to elevating stresses, changing in the bearing geometries, and increasing wear due to deformation of the cup and insert. In addition, there is a potential for failure of ceramic inserts when a large ball head was used because it should be assembled with shallow thickness of the acetabular cup. For risk reduction of it, we applied direct metal tooling (DMT) based on 3D printing for porous coating on the cup. Due to its capability of mechanical strength, DMT coated cup could be feasible to provide better stability than conventional coating. Therefore, we constructed laboratory models for deformation test simulating an press-fit situation with large ceramic ball head to evaluate stability of the DMT coated cup compared with conventional coated cup.

Materials and Methods

The deformation test was performed according to the test setup described by Z. M. Jin et al. The under reaming of the cavity in a two-point pinching cavity models of polyurethane (PU) foam block (SAWBONES, Pacific Research Laboratories, USA) with a grade 30 were constructed. Titanium plasma spray (TPS) and direct metal tooling (DMT) coated acetabular cups (BENCOX Mirabo and Z Mirabo Cup, Corentec Co. Ltd., KOREA) with a 52 mm size (n=3, respectively) were used for the test. These cups were implanted into the PU foam blocks, and followed by impaction of the inserts (BIOLOX delta, Ceramtec, GE) with a 36/44 size (n=6) into the acetabupar cups as shown in Fig. 1. Roundness and inner diameter of the acetabular cups and inserts were measured using a coordinate measuring machine (BHN 305, Mitutoyo Neuss, GE) in three levels; E2, E3, and E4 (3, 5, and 7 mm below the front face, respectively). Also, these parameters of the acetabular cup were measured in two level; E1 and E5 (5 and 11 mm below the front face) as shown in Fig. 2. Changes in roundness and inner diameter of the cup and insert were measured to evaluate deformation in relation to porous coating on the acetabular cups.


Bone & Joint Research
Vol. 11, Issue 10 | Pages 700 - 714
4 Oct 2022
Li J Cheung W Chow SK Ip M Leung SYS Wong RMY

Aims. Biofilm-related infection is a major complication that occurs in orthopaedic surgery. Various treatments are available but efficacy to eradicate infections varies significantly. A systematic review was performed to evaluate therapeutic interventions combating biofilm-related infections on in vivo animal models. Methods. Literature research was performed on PubMed and Embase databases. Keywords used for search criteria were “bone AND biofilm”. Information on the species of the animal model, bacterial strain, evaluation of biofilm and bone infection, complications, key findings on observations, prevention, and treatment of biofilm were extracted. Results. A total of 43 studies were included. Animal models used included fracture-related infections (ten studies), periprosthetic joint infections (five studies), spinal infections (three studies), other implant-associated infections, and osteomyelitis. The most common bacteria were Staphylococcus species. Biofilm was most often observed with scanning electron microscopy. The natural history of biofilm revealed that the process of bacteria attachment, proliferation, maturation, and dispersal would take 14 days. For systemic mono-antibiotic therapy, only two of six studies using vancomycin reported significant biofilm reduction, and none reported eradication. Ten studies showed that combined systemic and topical antibiotics are needed to achieve higher biofilm reduction or eradication, and the effect is decreased with delayed treatment. Overall, 13 studies showed promising therapeutic potential with surface coating and antibiotic loading techniques. Conclusion. Combined topical and systemic application of antimicrobial agents effectively reduces biofilm at early stages. Future studies with sustained release of antimicrobial and biofilm-dispersing agents tailored to specific pathogens are warranted to achieve biofilm eradication. Cite this article: Bone Joint Res 2022;11(10):700–714


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 2 - 2
1 Dec 2022
Pitton M Pellegatta D Vandoni D Graziani G Farè S
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The in vitro mimicking of bone microenvironment for the study of pathologies is a challenging field that requires the design of scaffolds with suitable morphological, structural and cytocompatible properties. During last years, 3D in vitro tumour models have been developed to reproduce mechanical, biochemical and structural bone microenvironment elements, allowing cells to behave as in vivo. In this work, gas foamed polyether urethane foams (PUF) and 3D printed thermoplastic polyether urethane (3DP-PU) designed with different patterns are proposed as scaffolds for in vitro model of bone tissue. Surface coatings for a biomimetic behaviour of the 3D scaffold models were also investigated. Morphological, chemico-physical, mechanical properties, and biological in vitro behaviour were investigated. PUFs for metastases investigation. The suitability of PUF as 3D in vitro model to study the interactions between bone tumour initiating cells and the bone microenvironment was investigated. PUF open porosity (>70%) appeared suitable to mimic trabecular bone structure. Human adipose derived stem cells (ADSC) were cultured and differentiated into osteoblast lineage on the PU foam, as confirmed by Alizarin Red staining and RT-PCR, thus offering a bone biomimetic microenvironment to the further co-culture with bone derived tumour-initiating cells (MCFS). Tumour aggregates were observed after three weeks of co-culture by e-cadherin staining and SEM; modification in CaP distribution was identified by SEM-EDX and associated to the presence of tumour cells. 3DP-PU as tumour bone model. 3D printed scaffolds have pores with a precise and regular geometry (0°-90°, 0°-45°-90°-135°, 0°-60°-120°). PU scaffold porosity evidenced values from 55 to 67%, values that belong to the porosity range of the trabecular bone tissue (30-90%). The compressive modulus varied between 2 and 4 MPa, depending on the printed pattern. Biomimetic nanostructured coating was performed on 0-90° 3DP-PU by Ionized Jet Deposition. Coatings had a submicrometric thickness, variable tuning deposition time, nanostructured surface morphology and biomimetic composition. Coating on 3DP-PU promoted cells colonization of the whole porous scaffolds, compared to the controls, where cells concentrated mostly on the outer layers. In conclusion, based on the obtained results, scaffolds with different geometries have been successfully produced. Morphological and structural properties of the scaffolds here presented are suitable for mimicking the bone tissue, in order to produce a 3D in vitro model useful for bone pathologies research


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_8 | Pages 31 - 31
11 Apr 2023
Powell D Wu B Dietz P Bou-Akl T Ren W Markel D
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Failure of osseointegration and periprosthetic joint infection (PJI) are the two main reasons of implant failure after total joint replacement (TJR). Nanofiber (NF) implant surface coating represents an alternative local drug eluting device that improves osseointegration and decreases the risk of PJI. The purpose of this study was to investigate the therapeutic efficacies of erythromycin (EM)-loaded coaxial PLGA/PCL-PVA NF coating in a rat S. aureus-infected tibia model. NF coatings with 100mg and 1000mg EM were prepared. NF without EM was included as positive control. 56 Sprague Dawley rats were divided into 4 groups. A titanium pin (1.0-mm x 8 mm) was placed into the tibia through the intercondylar notch. S. aureus (SA) was introduced by both direct injection of 10 μl broth (1 × 10. 4. CFU) into the medullary cavity and single dip of Ti pins into a similar solution prior to insertion. Rats were sacrificed at 8 and 16 weeks after surgery. The outcome measurements include μCT based quantitative osteolysis evaluation and hard tissue histology. Results: EM-NF coating (EM100 and EM1000) reduced osteolysis at 8 and 16 weeks, compared to EM0 and negative control. The effective infection control by EM-NFs was further confirmed by hard tissue section analysis. The Bone implant contact (BIC) and bone area fraction Occupancy (BAFO) within 200 µm of the surface of the pins were used to evaluate the osseointegration and new bone formation around the implants. At 16 weeks, the bone implant contact (BIC) of EM 100 (35.08%) was higher than that of negative control (3.43%) and EM0 (0%). The bone area fraction occupancy within 200 µm (BAFO) of EM100 (0.63 mm2) was higher than that of negative control (0.390 mm2) and EM0 (0.0 mm. 2. ). The BAFO of EM100 was also higher than that of EM1000 (0.3mm. 2. ). There was much less osteolysis observed with EM100 and EM1000 NF coatings at 16 weeks, as compared to EM0 positive control, p=0.08 and p=0.1, respectively. Osseointegration and periprosthetic bone formation was enhanced by EM-NFs, especially EM100. Data from this pilot study is promising for improving implant surface fabrication strategies


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_17 | Pages 23 - 23
24 Nov 2023
Xie C Ren Y Weeks J Lekkala S Rainbolt J Xue T Shu Y Lee K de Mesy Bentley KL Yeh S Schwarz E
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Title. Longitudinal Intravital Imaging to Quantify the “Race for the Surface” Between Host Immune Cell and Bacteria for Orthopaedic Implants with S. aureus Colonization in a Murine Model. Aim. To assess S. aureus vs. host cell colonization of contaminated implants vis intravital multiphoton laser scanning microscopy (IV-MLSM) in a murine model. Method. All animal experiments were approved by IACUC. A flat stainless steel or titanium L-shaped pin was contaminated with 10. 5. CFU of a red fluorescent protein (RFP) expressing strain of USA300LAC, and surgically implanted through the femur of global GFP-transgenic mice. IV-MLSM was performed at 2, 4, and 6 hours post-op. Parallel cross-sectional CFU studies were performed to quantify the bacteria load on the implant at 2,4,6,12,18 and 24 hours. Results. 1) We developed a high-fidelity reproducible IV-MLSM system to quantify S. aureus and host cell colonization of a bone implant in the mouse femur. Proper placement of all implants were confirmed with in vivo X-rays, and ex vivo photos. We empirically derive the ROI during each imaging session by aggregating the imaged volume which ranges from (636.4um × 636.4um × 151um) = 0.625 +/- 0.014 mm. 3. of bone marrow in a global GFP-transgenic mouse. 2) IV-MLSM imaging acquisition of the “race for the surface”.In vitro MPLSM images of implants partially coated with USA300LAC (RFP-MRSA) were verified by SEM image. Results from IV-MLSM of RFP-MRSA and GFP. +. host cell colonization of the contaminated implants illustrated the mutually exclusive surface coating at 3hrs, which to our knowledge is the first demonstration of “the race for the surface” between bacteria and host cells via intravital microscopy. 3) Quantifying the “race for the surface” with CFU verification of S. aureus on the implant. 3D volumetric rendering of the GFP. +. voxels and RFP+ voxels within the ROI were generated in Imaris. The voxel numbers suggeste that the fight for the surface concludes ∼3hrs post-infection, and then transitions to an aggressive MRSA proliferation phase. The results of WT control demonstrate a significant increase in CFU by 12hrs post-op for both stainless steel (P<0.01) and titanium (P<0.01). Conclusions. We developed IV-MLSM to quantify the “Race for the Surface” between host cells and contaminating S. aureus in a murine femur implant model. This race is remarkably fast, as the implant surface is completely covered with 3hrs, peak bacterial growth on the implant occurs between 2 and 12 hours and is complete by 12hrs


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 78 - 78
1 Feb 2020
Messer-Hannemann P Weyer H Morlock M
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INTRODUCTION. Reaming of the acetabular cavity prior to cementless cup implantation aims to create a defined press-fit between implant and bone. The goal is to achieve full implant seating with the desired press-fit to reduce the risk of early cup loosening and the risk of excessive cup deformation. Current research concentrated on the spherical deviations of the reamed cavity compared to the reamer size, but the direct relationship between nominal press-fit, reamer geometry, cavity shape and bone-implant contact has not yet been investigated. The aim of this study was to determine the influence of the reaming process, the surface coating, and the implantation force on the achieved press-fit situation. METHODS. Fresh-frozen porcine acetabulae (n = 20) were prepared and embedded. Hemispherical reamers were used and the last reaming step was performed using a vertical drilling machine to ensure a proper alignment of the cavity axis. A hand-guided 3D laser scanner was used (HandySCAN 700, Creaform) to determine the reamer geometry and the cavity shape. Press-fit cups with two different surface coatings (Ø44 mm, Porocoat/Gription, DePuy Synthes) were implanted using a drop tower. The Porocoat cup was implanted with impacts from lower drop heights (low implantation force) and press-fits of 1 mm and 2 mm. The Gription cup, exhibiting a rougher surface, was implanted with low and high implantation forces and a press-fit of 1 mm. Bone-implant contact was analysed by the registration of the cup and cavity surface models, scanned prior to implantation, to the scan of the implanted cup. The cup surface was divided in areas with and without contact to the surrounding cavity. Overhang indicates that there was no adjacent cavity surface surrounding the implanted cup. The transition between contact and a gap at the cup dome was defined as contact depth and used as indicator for the cup seating. RESULTS. The peripheral cavity diameter was on average 0.94 ± 0.29 mm smaller than the reamer diameter due to the sub-hemispherical distribution of the cutting blades. This led to an increased effective press-fit in the peripheral area of the cavity. The contact area between cup and bone increased with the implantation force (p = 0.008) and ranged from 13.1 % to 27.8 %. The contact depth was larger for the smoother Porocoat coating (p = 0.008), a press-fit of 2 mm (p = 0.008) and a higher implantation force (p = 0.008). DISCUSSION. This study shows that, assuming similar implantation forces, an increased surface roughness of the cup coating increases the risk of an insufficient cup seating. For a given press-fit, higher implantation forces would be necessary to fully seat the cup in order to enhance the bone-implant contact. Implantation of a cup without a defined nominal press-fit could increase the contact area; however a high reaming accuracy and an increased friction coefficient of the cup coating are required to compensate for a reduction in initial fixation strength caused by reduced radial compressive forces. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 69 - 69
1 Dec 2021
MacLeod A Taylor R Casonato A Gill H
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Abstract. Objectives. Additive manufacturing has led to numerous innovations in orthopaedic surgery: surgical guides; surface coatings/textures; and custom implants. Most contemporary implants are made from titanium alloy (Ti-6Al-4V). Despite being widely available industrially and clinically, there is little published information on the performance of this 3D printed material for orthopaedic devices with respect to regulatory approval. The aim of this study was to document the mechanical, chemical and biological properties of selective laser sintering (SLS) manufactured specimens following medical device (TOKA®, 3D Metal Printing LTD, UK) submission and review by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Methods. All specimens were additively manufactured in Ti-6Al-4V ELI (Renishaw plc, UK). Mechanical tests were performed according to ISO6892-1, ISO9585 and ISO12107 for tensile (n=10), bending (n=3) and fatigue (n=16) respectively (University of Bath, UK). Appropriate chemical characterisation and biological tests were selected according to recommendations in ISO10993 and conducted by external laboratories (Wickham Labs, UK; Lucideon, UK; Edwards Analytical, UK) in adherence with Good Lab Practise guidelines. A toxicological review was conducted on the findings (Bibra, UK). Results. The mechanical tests demonstrated that the material performed to the specification for conventionally manufactured titanium alloy of this type (ISO5832-3). The toxicology review concluded that there were no significant concerns for the health of the patients identified in this evaluation and implantation of the TOKA® device would not result in a significant health risk to patients. Conclusions. Reflecting on our MHRA experience, additive manufacture of orthopaedic devices is still considered to be a ‘novel’ process by regulatory bodies, requiring additional safety evidence. Despite this, our findings demonstrate that there is no difference, mechanically or chemically, to the traditionally manufactured alloy material. We hope to support the widening use of 3D printed titanium alloy orthopaedic devices by publishing our route to regulatory approval. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 59 - 59
1 Jun 2018
Su E
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Surface coatings have been introduced to total joint orthopaedics over the past decades to enhance osseointegration between metal implants and bone. However, complications such as aseptic loosening and infection persist. Inadequate osseointegration remains a complication associated with implants that rely on osseointegration for proper function. This is particularly challenging with implants having relatively flat and small surface areas that have high shear loading, such as noncemented uni and total condylar knee tibial trays. Faster osseointegration can enhance recovery as a result of improved load distribution and a more stable bone-implant interface. Traditionally noncemented porous bone ingrowth coatings on knee, hip and shoulder implants are typically texturised by thermal plasma spray coating, sintered metal bead coatings, or 3-D additive manufactured structures that provide porous surface features having the rough texture with pore sizes on the order of 150 to 300 micrometers. These surfaces are often further chemically enhanced with hydroxyapatite (HA) deposition. This provides macro-mechanical (millimeter scale) and micro-mechanical (micrometer scale) bone remodeling into the implant surface. However, at the nanoscale and cellular level, these surfaces appear relatively smooth. More recent studies are showing the importance of controlling the macro, micro, and the nano (nanometer scale) surface topographies to enhance cell interaction. In vitro and in vivo research shows surfaces with nanoscale features in the metal substrate result in enhanced osseointegration, greater bone-implant contact area and pullout force, and potentially bactericidal. One surface modification treatment technique of particular promise is nano-texturing via electrochemical anodization to bio-mimicking TiO2 nanotube arrays that are superimposed onto existing porous surface microstructures to further enhance the already known bone ingrowth properties of these porous structures by superimposing onto the existing microstructure arrays of nanotubes approximately 100 nanometers in outside diameter and 300–500 nanometers in height. In an ovine model, 3-D printed Direct Metal Laser Deposition (DMLS) additive manufactured porous Ti-6Al-4V implant with and without TiO2 nanotube array nano-texturing were compared to similar sized implants with commercially available sintered beads with HA coating and additive manufactured cobalt chrome implants. The average bond strength was significantly higher (42%) when the implants were nano-texturised and similarly stronger (53%) compared to HA coated sintered bead implants. Histology confirms over 420% more direct bonded growth of new bone from 0.5mm to 1.0mm deep into the porosity on the implants when the same implants are nano-texturised. Nano-texturing also changes the surface of the implant to repel methicillin-resistant staphylococcus aureus (MRSA) in an in vivo rabbit model limiting biofilm formation on the porous surface compared with non-treated porous surfaces. Since nano-texturizing only modifies the nano-morphology of the surface and does not add antibiotics or other materials to the implant, these animal studies shows great promise that nano-texturizing the TiO2 coating may not only enhance osseointegration, but also repels bacteria from porous implant surfaces. As such, we believe nano-texturing of porous implants will be the next advancement in surface coating technology


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 74 - 74
1 Dec 2020
Köse N Bayrak ÇH Köse AA Sevencan A Toktaş AG Doğan A
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Orthopaedic and trauma implant related infection remains one of the major complications that negatively impact clinical outcome and significantly increase healthcare expenditure. Hydroxyapatite has been used for many years to increase implant osseointegration. Silver has been introduced into hydroxyapatite as an antimicrobial coating for orthopedic implants. This surface coatings can both increase tissue compatibility and prevent implant-related infections. We examined infection markers and blood silver values, liver and kidney function tests of 30 patients with of three groups of orthopedic implants, external fixators, intramedullary nails and hip replacements, coated with Ag + ion doped CaP based ceramic powder to determine safety and effectiveness of this dual-function coating. During 1 year follow-up, the pin sites were observed at the external fixator group, and wound areas for the proximal femoral nail and hip arthroplasty group at regular intervals. In addition, liver and kidney function tests, infection markers and blood silver values were checked in patients. In the external fixator group, only 4 out of 91 pin sites (%4.39) were infected. The wound areas healed without any problem in patients with proximal femoral nails and hip arthroplasty. There was no side effect suggesting silver toxicity such as systemic toxic side effect or argyria in any patient and blood silver level did not increase. Compared to similar patient groups in the literature, much lower infection rates were obtained (p = 0.001), and implant osseointegration was good. In patients with chronic infection, the implants were applied acutely after removing the primary implant and with simple debridement. Unlike other silver coating methods, silver was trapped in hydroxyapatite crystals in the ionic form, which is released from the coating during the process of osseointegration, thus, the silver was released into the systemic circulation gradually that showed antibacterial activity locally. We conclude that the use of orthopedic implants with a silver ion added calcium phosphate-based special coating is a safe method to prevent the implant-related infection. This work was supported by TUBİTAK Project Number 315S101


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_2 | Pages 42 - 42
1 Jan 2019
Lal S Hall R Tipper JL
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Since 2010, there has been a sharp decline in the use of metal-on-metal joint replacement devices due to adverse responses associated with the release of metal wear particles and ions in patients. Surface engineered coatings offer an innovative solution to this problem by covering metal implant surfaces with biocompatible and wear resistant materials. The present study tests the hypothesis whether surface engineered coatings can reduce the overall biological impact of a device by investigating recently introduced silicon nitride coatings for joint replacements. Biological responses of peripheral blood mononuclear cells (PBMNCs) to Si3N4 model particles, SiNx coating wear particles and CoCr wear particles were evaluated by testing cytotoxicity, inflammatory cytokine release, oxidative stress and genotoxicity. Clinically relevant wear particles were generated from SiNx-on-SiNx and CoCr-on-CoCr bearing combinations using a multidirectional pin-on-plate tribometer. All particles were heat treated at 180°C for 4 h to destroy endotoxin contamination. Whole peripheral blood was collected from healthy donors (ethics approval BIOSCI 10–108, University of Leeds). The PBMNCs were isolated using Lymphoprep (Stemcell) and incubated with particles at various volumetric concentrations (0.5 to 100 µm3 particles/cell) for 24 h in 5% (v/v) CO2 at 37°C. After incubation, cell viability was measured using the ATPlite assay (Perkin Elmer); TNF-alpha release was measured by ELISA (Invitrogen); oxidative stress was measured using H2DCFDA (Abcam); and DNA damage was measured by comet assay (Tevigen). The results were expressed as mean ± 95% confidence limits and the data was analysed using one-way ANOVA and Tukey-Kramer post-hoc analysis. No evidence of cytotoxicity, oxidative stress, TNF-alpha release, or DNA damage was observed for the silicon nitride particles at any of the doses. However, CoCr wear particles caused cytotoxicity, oxidative stress, TNF-alpha release and DNA damage in PBMNCs at high doses (50 µm3 particles per cell). This study has demonstrated the in-vitro biocompatibility of SiNx coatings with primary human monocytic cells. Therefore, surface engineered coatings have potential to significantly reduce the biological impact of metal components in future orthopaedic devices


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 50 - 50
1 Feb 2021
Sanchez E Schilling C Grupp T Giurea A Verdonschot N Janssen D
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Introduction. Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions. Methods. Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables. Results. No significant difference was found for the micromotions between the two interference fit implants (gait p=0.755, squat p=0.232), nor for interfacial gaps (gait p=0.474, squat p=0.269). In contrast, significant differences were found for the ROIs in the two dependent variables (p < 0.001). The micromotions in the anterior ROIs (AM and AL) showed fewer micromotions for the low interference fit implant (Figure 2). More closing gaps (negative values) were seen for all ROIs (Figure 3), except in AM ROI during squat, which showed opening gaps (positive values). The posterior ROIs (PM and PL) showed more closing than seen in the anterior ROIs (AM and AL) for both loading configurations. Discussion. The results presented here demonstrate that increasing the interference fit from 350 µm to 700 µm does not affect the micromotions at the implant-bone interface of tibial TKA. While micromotions values were all below the threshold for bone ingrowth (40 µm), closing gaps were quite substantial (∼−150 µm). Since cementless e.motion® TKA components with an interference fit of 350 µm had shown a survival rate of 96.2% after 8.3 years postoperatively, interfacial gaps can be expected to be within a threshold value that can guarantee good primary stability. Moreover, increasing the interference fit to 700 µm can be considered a good range for an interference fit. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_1 | Pages 42 - 42
1 Feb 2021
Wright J Gehrke C Mallow M Savage P Wiater P Huber C Baker E
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Introduction. Pin-tract infections are a common problem in orthopaedic surgery, which limits the time an external fixator or Taylor spatial frame can be applied to a patient. The purpose of our study is to evaluate the ability of a novel implant surface coating — cationic steroid antibiotic (CSA)-44 — to delay or prevent the onset of these infections. This coating mimics endogenous antimicrobial peptides of the innate immune system and has been shown to effectively eradicate biofilms as well as prevent infection and stimulate healing of open, contaminated fractures. Methods. Surgeries were performed on 20 animals (outbred; Sprague-Dawley strain rats). Each animal received both CSA-coated and standard-of-care titanium pins, with pins randomized to the fifth or sixth vertebrae prior to surgeries. Animals were also randomized to either “Imaging” (imaging analysis) or “Infection” (microbiological analysis) cohorts. Surgeons were blinded to pin types and analyses cohorts. Digital images of pin sites were collected weekly over 12 weeks, and then graded by two orthopaedic surgery residents according to an established Likert scale. Graders were blinded to animal numbers, pin types, and timepoints (Figure 1). For the infection analysis cohort, four specimens per site were subjected to microbiological analysis from each site (i.e. pin, superficial skin swab, deep skin swab, sonicated bone). Each specimen was processed on three different microbiological plates (i.e. BAP, CAN, MAC) using standardized techniques. Imaging analysis was performed by dissecting vertebrae en bloc with pin retained, followed by fixation in 10% neutral buffered formalin for 72 hours. Following a graded ethanol series and storage in 70% ethanol, specimens were scanned with microcomputed tomography (µCT). Statistical analyses were performed to compare pin site appearance (chi-square testing) as well as total bacterial colony counts within each plate cohort and imaging data (Kruskal-Wallis testing); for all tests, significance was set at α=0.05. Results. Weekly digital images of each pin site were collected, graded, and then averaged (Figure 2). Statistical analysis showed no significant difference in pin appearance between the control and CSA pin cohorts at any timepoints. For the infection analysis cohort, bacterial colonies were counted on BAP, CAN, and MAC plates, followed by bacteria species identification (Figure3). Statistical analysis showed no significant difference in total bacterial colony counts between the control and CSA pin cohorts in any of the plate groups. For the imaging cohort, post-processing and subsequent data and statistical analyses are ongoing. Discussion. No significant differences were found between the control and CSA pin cohorts, with respect to pin appearance during the 12-week study or total bacterial colony counts on three plates, indicating that the control and CSA pins performed equivalently. Imaging analysis is ongoing. Although the environmentally-acquired infection model in an outbred rat strain was used to replicate the onset of pin tract infections in human populations, many animals showed Grade 1 or 2 pin site appearances at the 12-week endpoint. A follow-on study is underway using a direct bacterial seeding model. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_2 | Pages 132 - 132
2 Jan 2024
Rau J
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Over the last decades, biodegradable metals emerged as promising materials for various biomedical implant applications, aiming to reduce the use of permanent metallic implants and, therefore, to avoid additional surgeries for implant removal. However, among the important issue to be solved is their fast corrosion - too high to match the healing rate of the bone tissue. The most effective way to improve this characteristic is to coat biodegradable metals with substituted calcium phosphates. Tricalcium phosphate (β-TCP) is a resorbable bioceramic widely used as synthetic bone graft. In order to modulate and enhance its biological performance, the substitution of Ca2+ by various metal ions, such as strontium (Sr2+), magnesium (Mg2+), iron (Fe2+) etc., can be carried out. Among them, copper (Cu2+), manganese (Mn2+), zinc (Zn2+) etc. could add antimicrobial properties against implant-related infections. Double substitutions of TCP containing couples of Cu2+/Sr2+ or Mn2+/Sr2+ ions are considered to be the most perspective based on the results of our study. We established that single phase Ca3−2x(MˊMˊˊ)x(PO4)2 solid solutions are formed only at x ≤ 0.286, where Mˊ and Mˊˊ—divalent metal ions, such as Zn2+, Mg2+, Cu2+, Mn2+, and that in case of double substitutions, the incorporation of Sr2+ ions allows one to extend the limit of solid solution due to the enlargement of the unit cell structure. We also reported that antimicrobial properties depend on the substitution ion occupation of Ca2+ crystal sites in the β-TCP structure. The combination of two different ions in the Ca5 position, on one side, and in the Ca1, Ca2, Ca3, and Ca4 positions, on another side, significantly boosts antimicrobial properties. In the present work, zinc-lithium (Zn-Li) biodegradable alloys were coated with double substituted Mn2+/Sr2+ β-TCP and double substituted Cu2+/ Sr2+ β-TCP, with the scope to promote osteoinductive effect (due to the Sr2+ presence) and to impart antimicrobial properties (thanks to Cu2+ or Mn2+ ions). The Pulsed Laser Deposition (PLD) method was applied as the coating's preparation technique. It was shown that films deposited using PLD present good adhesion strength and hardness and are characterized by a nanostructured background with random microparticles on the surface. For coatings characterization, Fourier Transform Infrared Spectroscopy, X-ray Diffraction, and Scanning Electron Microscopy coupled with Energy Dispersive X-ray and X-ray Photoelectron Spectroscopy were applied. The microbiology tests on the prepared coated Zn-Li alloys were performed with the Gram-positive (Staphylococcus aureus, Enterococcus faecalis) and Gram-negative (Salmonella typhimurium, Escherichia coli) bacteria strains and Candida albicans fungus. The antimicrobial activity tests showed that Mn2+/Sr2+ β-TCP -coated and Cu2+/Sr2+ β-TCP coated Zn-Li alloys were able to inhibit the growth of all five microorganisms. The prepared coatings are promising in improving the degradation behavior and biological properties of Zn-Li alloys, and further studies are necessary before a possible clinical translation


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 16 - 16
1 Dec 2020
Kontakis MG Schou J Hailer N
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Bone tissue engineering attempts at substituting critical size bone defects with scaffolds that can be primed with osteogenic cells, usually mesenchymal stem cells (MSC) from the bone marrow. Although overlooked, peripheral blood is a valuable source of MSC and circulating osteoprogenitors (COP), bearing a significant regenerative potential, and peripheral blood is easier to access than bone marrow. We thus studied osteodifferentiation of peripheral blood mononuclear cells (pbMNC) under different culture conditions, and how they compared to primary human osteoblasts. pbMNC were isolated from healthy adult volunteers by Ficoll density gradient centrifugation, and they were then cultured using media supplemented with 100nM Dexamethasone, 10mM sodium β-glycero phosphate and ascorbic acid (either 40mM or 0.05mM). For comparison, primary osteoblasts were isolated from the femoral heads of patients undergoing hip arthroplasty. After 4 weeks of culture, osteogenic activation was quantified with spectrometric measurement of alkalic phosphatase (ALP) and lactate dehydrogenase (LDH) levels. The extent of osteoid mineralization was measured with Alizarin red staining. We studied the effects of 1) varying cell concentration at seeding, 2) surface coating of culture wells with collagen and 3) high compared to low ascorbic acid (40mM and 0.05mM) media. Higher numbers of pbMNC (0.5–5.9 versus 0.062–0.25 million cells per well) at seeding resulted in a lower ALP/LDH-ratio (mean ± standard deviation), 0.39 ± 0.33 arbitrary units (AU) versus 1.36 ± 1.06 AU, but led to higher amount of osteoid production, 0.10 ± 0.06 versus 0.065 ± 0.02 AU, p < 0.05. Culture of pbMNC on collagen did not confer any difference in ALP/LDH-ratios, with 0.43 ± 0.3 AU for collagen-coated and 0.43 ± 0.41 AU for uncoated wells (p = 0.95), and we also observed no relevant difference in osteoid production (0.07 ± 0.01 AU for collagen-coated versus 0.1 ± 0.08 AU for uncoated wells, p = 0.28). Cultures of pbMNC on collagen in media supplemented with a higher concentration of ascorbic acid showed a 130% higher ALP/LDH-ratio when compared to cultures exposed to a lower ascorbic acid concentration (p < 0.05). Cultures with a low initial concentration of pbMNC (0.5 − 1 million cells) had no significantly different ALP/LDH-ratio when compared to primary human osteoblasts, but the cultures of pbMNC resulted in a 90% increase in osteoid mineralization when compared to primary human osteoblasts (p < 0.05). These findings indicate that progenitor cells derived from peripheral blood have a significant osteogenic potential, rendering them interesting candidates for seeding of scaffolds intended to fill critical sized bone defects. pbMNC produced almost double the amount of osteoid as primary osteoblasts. The isolation of pbMSC and COP is non-invasive and easy, and they might be seeded directly onto scaffolds without prior ex-vivo expansion, a question that we intend to pursue further


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 84 - 84
1 Jul 2020
Chow D Qin L Wang J Yang K Wan P
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Patellar fractures account for approximately 1% of all fractures. Open reduction and internal fixation is recommended to restore extensor continuity and articular congruity. However, complications such as nonunion and symptomatic hardware, still exist. Furthermore, there is a risk of re-fracturing of the healed bone during the removal of the implants. Magnesium (Mg), a biodegradable metal, has elastic moduli and compressive yield strength that are comparable to those of natural bone. Our previous study showed that released Mg ions enhanced fracture healing. However, Mg-based implants degrade rapidly after implantation and lead to insufficient mechanical strength to support the fracture. Microarc oxidation (MAO) is a metal surface coating that reduces corrosion. We hypothesized that Mg pins, with or without MAO, would enhance fracture healing radiologically, mechanically, and histologically, while MAO would decrease degradation of Mg pins. Patellar fracture was performed on forty-eight 18-week-old female New Zealand White rabbits according to established protocol. Briefly, the patella is osteotomized transversely and a tunnel (1.1mm) was drilled longitudinally through the two bone fragments. A pin (1 mm, stainless steel, Mg, or MAO-Mg) was inserted into the tunnel. The reduced construct was stabilized with a figure-of-eight band wire (⊘ 0.6 mm stainless steel wire). Cast immobilization was applied for 6 weeks. The rabbits were euthanized at week 8 and 12 post-operation. Microarchitecture and mechanical properties of the repaired patella were analyzed with microCT and tensile testing respectively. Histological sections of the repaired patella were stained. To evaluate the effect of the MAO treatment on degradation rate of Mg pin, the volume of the Mg pins in the patella was measured with microCT. At week 8, both Mg and Mg-MAO showed higher ratio of bone volume to tissue volume (BV/TV) than the control while there was no significant different between Mg and Mg-MAO. At week 12, Control, Mg, and Mg-MAO groups showed enlarged patella when compared to the normal patella. Tissue volume (TV) and bone volume (BV) of the patella in Mg and Mg-MAO were larger than those in the Control group. However, the Control had higher ratio of bone volume to tissue volume (BV/TV), TV density, and BV density than Mg and Mg-MAO. Tensile testing showed that the mechanical properties of the repaired patella (failure load, stiffness, ultimate strength, and energy-to-failure) of Mg and Mg-MAO were higher than that of the control at both week 8 and week 12. Histological analysis showed that there was significant new bone formation in the Mg and Mg-MAO group compared with the Control group at week 8 and 12. The degradation rate of the MAO-coated Mg pins was significantly slower than those without MAO at week 8 but no significant difference was detected at week 12. Mechanical, microarchitectural, and histological assessments showed that Mg pins, with or without MAO, enhanced fracture healing of the repaired patella compared to the Control. MAO treatment enhanced the corrosion resistance of the Mg pins at the early time point


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 121 - 121
1 Apr 2017
Gustke K
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Removing well-fixed components can be difficult. It can be required in instances of infection, malalignment, instability and polyethylene wear. Success requires patience, skill and the use of correct instruments. Using too much force or haste will result is excessive bone loss and a more difficult reconstruction. One's goal should be to save bone and save time. The surgeon must be familiar with the implants to know if any special techniques will be required to deal with modularity of the tibial polyethylene, surface coatings and geometry of pegs and stems. The usual steps are to remove the tibial liner if modular, followed by removal of the femoral component, then tibial component. Thin osteotomes are used to loosen the cement prosthesis or bone prosthesis interfaces to be able to remove the implants and not lose bone in the process. Removal of cement mantles around long-stemmed femoral and tibial components can be facilitated by femoral cortical window osteotomies and tibial crest osteotomies


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 92 - 92
1 Apr 2018
Messer P Baetz J Lampe F Pueschel K Klein A Morlock M Campbell G
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INTRODUCTION. The restoration of the anatomical hip rotation center (HRC) has a major influence on the longevity of hip prostheses. Deviations from the HRC of the anatomical joint after total hip arthroplasty (THA) can lead to increased hip joint forces, early wear or loosening of the implant. The contact conditions of acetabular press-fit cups after implantation, including the degree of press-fit, the existence of a polar gap and cup orientation, may affect the HRC restoration, and therefore implant stability. The aim of this study was to determine the influence of acetabular press-fit, polar gap and cup orientation on HRC restoration during THA. METHODS. THAs were performed by an experienced orthopaedic surgeon in full cadaveric models simulating real patient surgery (n=7). Acetabular cups with a Porocoat™ (n=3) and Gription™ surface coating (n=4) were implanted (DePuy Synthes, Leeds, UK). Computed tomography (CT) scans prior to surgery, as well as after reaming and implantation of press-fit cups were used to calculate the HRC displacement. After aligning the pelves in the anterior pelvic plane, 3D reconstruction of the HRC at each stage was performed by fitting spheres to the femoral head, the reamed cavity and the inserted cup. 3D surface models of the cups were generated using a laser scanner and were registered to the CT images. The effective press-fit was calculated using the diameters of spheres, fitted to the cavity prior to cup insertion and to the outer cup coating. The polar gap was defined as the difference between the outer cup surface and the subchondral bone at the cup pole. Anteversion and abduction angles were calculated as difference between the cup planes and the sagittal and transverse plane, respectively. RESULTS. A medial (6.4±1.6mm), superior (5.1±1.5mm) and posterior (3.0±1.4mm) displacement of the HRC after reaming was measured. A significant inferior shift of the HRC could be measured after cup implantation (p=0.043). No significant influence of the coating design on the HRC shift could be observed. The shift of the HRC back towards the anatomical HRC was highly correlated to the degree of polar gap (R. 2. =0.928, p<0.001) and a trend towards an association with effective press-fit was observed (R. 2. =0.536, p=0.061). The cup angles had no influence on the shift of the HRC, but a high variability in cup anteversion (20.7° to 61.8°) was observed. DISCUSSION. The study suggests that increasing the press-fit and polar gap improves the restoration of the anatomical HRC. Since increasing the degree of press-fit could also lead to higher stresses and an increased fracture risk, future work will study how the acetabular contact conditions influence both primary implant stability and fracture risk, in order to establish an optimal HRC reconstruction to maximize implant longevity