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Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 253 - 253
1 Jul 2014
Melli V Rondelli G Sandrini E Altomare L Bolelli G Bonferroni B Lusvarghi L Chiesa R De Nardo L
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Summary. Metal Injection Molding could provide cost saving of about 20–50% for implantable medical device manufacturing and hence healthcare public spending. Corrosion behaviour and biocompatibility of the new manufactured alloy were studied and showed similar behaviour compared to the traditional one. Introduction. The growing trend for total joint arthroplasties could raise healthcare costs in the near future. Metal Injection Molding (MIM) is a near net shape manufacturing technology and allows the production of finite prosthesis components saving the machining step, and so resources, up to 20–50%. In order to apply such process to the production of actual devices, the bulk material have to show biocompatibility and corrosion behaviour similar to the traditional one. (ASTM F2083, ISO 21536) The aim of this work was to compare cast and forged CoCrMo alloy with the MIM one from the electrochemical point of view and cytocompatibility. Material and Methods. Metallographic observations by optical microscopy and SEM were taken to better understand the electrochemical behaviour. This evaluation was performed through potentiodynamic tests on MIM and forged (FOR) samples with polished and sandblasted surfaces (as the actual devices), in ASTM G5 cell with saline solution simulating the body environment, graphite counter electrodes and Ag/AgCl 0.15M NaCl reference electrode. Linear polarization, open circuit potential measurements and potentiostatic tests at +335 mV vs SCE were also performed during 10 days to have direct information on the corrosion resistance and ion release. Cell viability were also assessed through MTT test on polished MIM and cast (CAS) elutes, after 2 and 7 days contact periods, following ISO 10993 directions. Static ion release in H. 2. O at 2, 4 and 8 weeks were also performed. Results. MIM showed coarser grains, free of boundary carbide but with lots of circular porosities and stacking faults, in comparison with CAS structure, which presented many carbides and typical dendritic grain. Electrochemical tests exhibited analogue behaviour for the MIM and FOR CoCrMo alloys. The slightly lower passive current density and transpassive potential values obtained could be ascribed to a passive oxide layer on the MIM sample less protective than FOR CoCrMo one, as inferable from the OCP measurements, but these facts had no visible influence on polarization resistance and ion release. Such good corrosion behaviour was reflected also in static ion release results and MTT viability results, which were comparable, not only to CAS samples but also to the control medium. Conclusions. From such preliminary results MIM technology showed to have good possibility for the production of implantable medical devices with CoCrMo alloy. Corrosion resistance and biocompatibility seemed not to be affected by the different manufacturing technique. Further studies will be needed to asses also the equivalence of mechanical properties. From the metallographic observations the absence of second phases and the homogeneous microstructure suggests a better fatigue performance for this kind of alloy, even if some concerns arise from the widespread porosity observed


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 78 - 78
4 Apr 2023
Voropai V Nieher M Kratsch A Kirchner W Giggel B Lohmann C Bertrand J Weißmantel S Döring J
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Total knee arthroplasty is one of the most common surgeries. About 92% of all implanted knee endorposthesis in 2020 were manufactured from uncoated CoCrMo articulating on ultra-high-molecular-weight polyethylene. All articluations generate wear particles and subsequent emission of metal ions due to the mechanical loading. These wear particles cause diverse negative reactions in the surrounding tissues and can lead to implant loosening. Coating technologies might offer the possibility to reduce this wear. Therefore, we investigated the applicability of tetrahedral amorphous carbon (ta-C) coating on CoCrMo alloy. Polished specimens made of CoCrMo wrought alloy according to ISO 5832-12 were coated with ta-C coatings with different layer structure using pulsed laser deposition (PLD). This process allows the deposition of ta-C coatings with low internal stress using an additional relaxation laser. Surface quality and mechanical properties of the coating were characterised using optical surface measurements (NanoFocus μsurf expert, NanoFocus AG) and a nanoindentation tester NHT. 3. (Anton Paar GmbH). Scratch tests were performed on Micro Scratch Tester MST. 3. (Anton Paar TriTec SA) to define the coating adhesion. Pin-on-plate tribological tests, with a polyethylene ball sliding on the ta-C-coated plate under a defined load according to ISO 14243-1 were performed using a linear tribometer (Anton Paar GmbH) to evaluate the tribological and wear properties. The ta-C coatings showed a mean roughness Ra of 5-20 nm and a hardness up to 60 GPa (n=3). The adhesion of the ta-C coatings (n=3) was comparable to the commercial coatings like TiN and TiNbN. The pin-on-plate tests showed an improvement of tribological properties in comparison with the polished uncoated CoCrMo specimens (n=3). The ta-C coatings applied by DLP technology show increased hardness compared to the base material and sufficient adhesion. Further research will be needed to investigate the optimal coating strategy for implant coating


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 85 - 85
4 Apr 2023
Wulfhorst M Büssemaker H Meinshausen A Herbster M Döring J Mai V Lohmann C Kautz A Laube T Wyrwa R Schnabelrauch M Bertrand J
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The implantation of endoprosthesis is a routine procedure in orthopaedics. Endoprosthesis are mainly manufactured from ceramics, polymers, metals or metal alloys. To ensure longevity of the implants they should be as biocompatible as possible and ideally have antibacterial properties, to avoid periprosthetic joint infections (PJI). Various antibacterial implant materials have been proposed, but have so far only been used sporadically in patients. PJI is one of the main risk factors for revision surgeries. The aim of the study was to identify novel implant coatings that both exhibit antibacterial properties whilst having optimal biocompatibility. Six different novel implant coatings and surface modifications (EBM TiAl6V4, strontium, TiCuN, TiNbN, gentamicin phosphate (GP), gentamicin phosphate+cationic polymer (GP+CP)) were compared to standard CoCrMo-alloy. The coatings were further characterized with regard to the surface roughness. E. coli and S. capitis were cultured on the modified surfaces to investigate the antibacterial properties. To quantify bacterial proliferation the optical density (OD) was measured and viability was determined using colony forming units (CFU). Murine bone marrow derived macrophages (BMMs) were cultured on the surfaces and differentiated into osteoblasts to quantify the mineralisation using the alizarin red assay. All novel coatings showed reduced bacterial proliferation and viability compared to standard CoCrMo-alloy. A significant reduction was observed for GP and GP+CP coated samples compared to CoCrMo (OD. GP,E.coli. = 0.18±0.4; OD. GP+CP,E.coli. = 0.13±0.3; p≤0.0002; N≥7-8). An increase in osteoblast-mediated mineralisation was observed on all surfaces tested compared to CoCrMo. Furthermore, GP and GP+CP coated samples showed a statistically significant increase (M. GP. = 0.21±0.1; M. GP+CP. = 0.25±0.2; p<0.0001; N≥3-6). The preliminary data indicates that the gentamicin containing surfaces have the most effective antibacterial property and the highest osseointegrative capacity. The use of antibiotic coatings on prostheses could reduce the risk of PJI while being applied on osseointegrative implant surfaces


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 717 - 725
1 May 2010
Kamali A Hussain A Li C Pamu J Daniel J Ziaee H Daniel J McMinn DJW

Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles. There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants. Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 6 - 6
1 Apr 2017
Kretzer J Sonntag R Kiefer H Reinders J Porporati AA Streicher R
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Background. The CoCrMo large bearings had shown a high failure rate, because of metal ion and particle release. Alumina matrix composite (AMC) ball heads have shown to mitigate such phenomena. The aim of this study was to investigate the leaching properties of AMC clinically as well as experimentally. Methods. Two patient groups were compared: a control group (n=15) without any implant (Controls) and 15 Patients with unilateral treatment with Biolox delta ceramic-on-ceramic (CoC). Whole-blood samples of Controls and Patients (after 3 and 12 months from treatment with CoC) were measured by means of trace element analysis using a HR-ICPMS. The leaching behaviour of BIOLOX delta was also analysed in-vitro: five Biolox delta heads and five CoCrMo heads were immersed in serum for seven days at 37°C. Aluminium, cobalt, chromium and strontium were detected based on HR-ICPMS. Results. In Patients, most elements remained below the limit of detection (LoD), except for aluminium and strontium. The aluminium values of Controls were below the LoD (27.2μg/L). The values of Patients after three months show a median of 34.2μg/L and after 12 months 37.1μg/L (p=0,510). Strontium ranged from 39.7μg/L of Controls and 79.6μg/L and 70.7μg/L of Patients, after three and twelve months, respectively. This difference was not statistically significant (p=0,322). The leaching experiments showed high amounts of cobalt (177.3μg/L) and chromium (4.2μg/L) released by CoCrMo. Ceramic heads didn't show any significant release. Conclusions. The current study revealed that there was no significant increase of any element in patients with CoC bearings. Metal heads released high values of cobalt in leaching test. As this release occurred even without any joint articulation, as shown in the experiments, surface corrosion seems to be a relevant mechanism in the ion release of metal bearings. A limitation of the study is that Controls differed from Patients within the clinical trial. Level of evidence. III


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 44 - 44
1 Aug 2012
Drew T Gibson J Burke J
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Growth rods are currently used in young children to hold a scoliosis until the spine has reached a mature length. Only partial deformity correction is achieved upon implantation, and secondary surgeries are required at 6-12 month intervals to lengthen the holding rod as the child grows. This process contains, rather than corrects, the deformity and spinal fusion is required at maturity. This treatment has a significant negative impact on the bio-psychosocial development of the child. Aim. To design a device that would provide a single minimally invasive, non-fusion, surgical solution that permits controlled spinal movement and delivers three dimensional spinal correction. Method. Physical and CAD implant models were developed to predict curve and rotational correction during growth. This allowed use of static structural finite element analysis to identify magnitudes and areas of maximum stress to direct the design of prototype implants. These were mechanically tested for strength, fatigue and wear to meet current Industrial standards. Results. A dynamic hinged construct, was produced. This consisted of carbon nitride coated CoCrMo components assembled in a modular fashion. Five implants were tested under static load to simulate spinal flexion establishing a mean average yield point at a bending moment of 20.8 Nm (SD 2.5 Nm). Six samples were tested for fatigue endurance to 10 million cycles. Two implants were loaded with a 10 Nm maximum bending moment without fracture. Two samples were loaded at 14 Nm with one surviving and one fracturing at 569,048 cycles. Samples loaded at 16 Nm and 17 Nm both fractured at 3,460,359 and 237,613 cycles respectively. Two implants were tested for wear, the first fractured after 290,000 cycles. A second modified implant was tested to ten million cycles and a mean wear rate of 2.03 mg per million cycles was determined during this period. Exposure of the CoCrMo implant substrate was first observed at two million cycles. Conclusion. The device met all mechanical test criteria necessary for CE marking and allowed progression to implant testing in an ovine model


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 16 - 16
1 Aug 2012
Meswania J Biring G Wylie C Hua J Muirhead-Allwood S Blunn G
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Introduction. The National Joint Registry has recently identified failure of large head metal on metal hip replacements. This failure is associated with the high torque at the interface of standard modular taper junction leading to fretting and corrosion. A number of manufacturers produce mini spigots, which in theory, provide a greater range of motion as the neck head junction is reduced. However, the relative torque to interface ratio at this junction is also increased. In this study we investigated hypothesis that the use of small spigots (minispigots) will increase wear and corrosion on modular tapers. Methods. Wear and corrosion of spigots were compared in-vitro when loaded with a force representative of the resultant force passing through the hip. The heads (female tapers) were made of cobalt-chrome-molybdenum (CoCrMo) and the stems (male tapers) of titanium alloy (Ti). Commercially available tapers and heads were used. The surface parameters & profiles were measured before & after testing. Electrochemical static and dynamic corrosion (pitting) tests were performed on minispigots under loaded and non-loaded conditions. Results. Post-testing the surface parameters Ra, Ry & Rz on the head taper associated with the minispigots had become greater compared with standard spigots. In all instances the profile of the titanium male tapers was unchanged. SEM showed the corroded region of the head was similar to the profile on the Ti male taper, with evidence of pitting in the cobalt chrome. In the CoCrMo/ Ti combinations, wear and corrosion were increased in minispigots compared with standard spigots. On minispigots the rough surface finishes were affected more severely than those with a smoother surface. Static corrosion tests showed evidence of fretting in the rough but not the smooth minispigots. Pitting scans showed a greater hysteresis with the rough surface finishes on the minispogot indicating potentially greater corrosion in the former. Conclusion. The relative size of the taper in comparison to the head combined with the surface finish was crucial. As the relative torque to interface ratio at this junction increased corrosion of the cobalt chrome head increases and is further enhanced if the surface finish on the tapers is rough