Analysis of the Attune tibial tray backside: A comparative retrieval study.

OBJECTIVES: The Attune total knee arthroplasty (TKA) has been used in over 600 000 patients worldwide. Registry data show good clinical outcome; however, concerns over the cement-tibial interface have been reported. We used retrieval analysis to give further insight into this controversial topic. METHODS: We examined 12 titanium (Ti) PFC Sigma implants, eight cobalt-chromium (CoCr) PFC Sigma implants, eight cobalt-chromium PFC Sigma rotating platform (RP) implants, and 11 Attune implants. We used a peer-reviewed digital imaging method to quantify the amount of cement attached to the backside of each tibial tray. We then measured: 1) the size of tibial tray thickness, tray projections, peripheral lips, and undercuts; and 2) surface roughness (Ra) on the backside and keel of the trays. Statistical analyses were performed to investigate differences between the two designs. RESULTS: There was no evidence of cement attachment on any of the 11 Attune trays examined. There were significant differences between Ti and CoCr PFC Sigma implants and Attune designs (p < 0.05); however, there was no significant difference between CoCr PFC Sigma RP and Attune designs (p > 0.05). There were significant differences in the design features between the investigated designs (p < 0.05). CONCLUSION: The majority of the earliest PFC Sigma designs showed evidence of cement, while all of the retrieved Attune trays and the majority of the RP PFC trays in this study had no cement attached. This may be attributable to the design differences of these implants, in particular in relation to the cement pockets. Our results may help explain a controversial aspect related to cement attachment in a recently introduced TKA design.Cite this article: A. Cerquiglini, J. Henckel, H. Hothi, P. Allen, J. Lewis, A. Eskelinen, J. Skinner, M. T. Hirschmann, A. J. Hart. Analysis of the Attune tibial tray backside: A comparative retrieval study. Bone Joint Res 2019;8:136-145. DOI: 10.1302/2046-3758.83.BJJ-2018-0102.R2.

Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007.

OBJECTIVES: Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. METHODS: A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The 'pre-2007' group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the '2007 onwards' group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors. RESULTS: There was no significant difference between the taper and bearing wear rates of the 'pre-2007' and '2007 onwards' groups (p = 0.67 and p = 0.39, respectively). Pinnacles implanted from 2007 onwards were revised after a mean time of 50 months, which was significantly earlier than the 'pre-2007' hips (96 months) (p < 0.001). A reduction in the time to revision was present year on year from 2003 to 2011. CONCLUSION: We found no difference in the wear rate of these implants based on the year of implantation. The 'pre-2007' hips had a two-fold greater time to revision than those implanted after 2007; this may be due to the increased surveillance of MoM hips following UK regulatory advice and several high-profile failures. Interestingly, we observed a decreasing trend in the mean time to revision every year from 2003 onwards.Cite this article: S. Bergiers, H. S. Hothi, J. Henckel, A. Eskelinen, J. Skinner, A. Hart. Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007. Bone Joint Res 2018;7:595-600. DOI: 10.1302/2046-3758.711.BJR-2018-0143.R1.

A retrieval analysis of the Precice intramedullary limb lengthening system.

OBJECTIVES: The Precice nail is the latest intramedullary lengthening nail with excellent early outcomes. Implant complications have led to modification of the nail design. The aim of this study was to perform a retrieval study of Precice nails following lower-limb lengthening and to assess macroscopical and microscopical changes to the implants and evaluate differences following design modification, with the aim of identifying potential surgical, implant, and patient risk factors. METHODS: A total of 15 nails were retrieved from 13 patients following lower-limb lengthening. Macroscopical and microscopical surface damage to the nails were identified. Further analysis included radiology and micro-CT prior to sectioning. The internal mechanism was then analyzed with scanning electron microscopy and energy dispersive x-ray spectroscopy to identify corrosion. RESULTS: Seven male and three female patients underwent 12 femoral lengthenings. Three female patients underwent tibial lengthening. All patients obtained the desired length with no implant failure. Surface degradation was noted on the telescopic part of every nail design, less on the latest implants. Microscopical analysis confirmed fretting and pitting corrosion. Following sectioning, black debris was noted in all implants. The early designs were found to have fractured actuator pins and the pin and bearings showed evidence of corrosive debris. The latest designs showed evidence of biological deposits suggestive of fluid ingress within the nail but no corrosion. CONCLUSION: This study confirms less internal corrosion following modification, but evidence of titanium debris remains. We recommend no change to current clinical practice. However, potential reuse of the Precice nail, for secondary limb lengthening in the same patient, should be undertaken with caution.Cite this article: V. C. Panagiotopoulou, K. Davda, H. S. Hothi, J. Henckel, A. Cerquiglini, W. D. Goodier, J. Skinner, A. Hart, P. R. Calder. A retrieval analysis of the Precice intramedullary limb lengthening system. Bone Joint Res 2018;7:476-484. DOI: 10.1302/2046-3758.77.BJR-2017-0359.R1.

Assessment of corrosion in retrieved spine implants.

Recently the use of dissimilar metals in spine instrumentation has increased, especially in the case of adult deformities, where rods made from Cobalt Chrome alloys (CoCr) are used with Titanium (Ti) screws. The use of dissimilar metals increases the risk of galvanic corrosion and patients have required revision spine surgery due to severe metallosis that may have been caused by corrosion. We aimed to assess the presence of corrosion in spine implant retrievals from constructs with two types of material combinations: similar (Ti/Ti) and dissimilar (CoCr/Ti). First, we devised a grading score for corrosion of the rod-fixture junctions. Then, we applied this score to a collection of retrieved spine implants. Our proposed corrosion grading score was proven reliable (kappa > 0.7). We found no significant difference in the scores between 4 CoCr and 11 Ti rods (p = 0.0642). There was no indication that time of implantation had an effect on the corrosion score (p = 0.9361). We recommend surgeons avoid using implants designs with dissimilar metals to reduce the risk of corrosion whilst a larger scale study of retrieved spine implants is conducted. Future studies can now use our scoring system for spine implant corrosion. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 632-638, 2018.

Retrieval analysis of metal and ceramic femoral heads on a single CoCr stem design.

OBJECTIVES: The use of ceramic femoral heads in total hip arthroplasty (THA) has increased due to their proven low bearing wear characteristics. Ceramic femoral heads are also thought to reduce wear and corrosion at the head-stem junction with titanium (Ti) stems when compared with metal heads. We sought to evaluate taper damage of ceramic compared with metal heads when paired with cobalt chromium (CoCr) alloy stems in a single stem design. METHODS: This retrieval study involved 48 total hip arthroplasties (THAs) with CoCr V40 trunnions paired with either CoCr (n = 21) or ceramic (n = 27) heads. The taper junction of all hips was evaluated for fretting/corrosion damage and volumetric material loss using a roundness-measuring machine. We used linear regression analysis to investigate taper damage differences after adjusting for potential confounding variables. RESULTS: We measured median taper material loss rates of 0.210 mm3/year (0.030 to 0.448) for the metal head group and 0.084 mm3/year (0.059 to 0.108) for the ceramic group. The difference was not significant (p = 0.58). Moreover, no significant correlation between material loss and implant or patient factors (p > 0.05) was found. CONCLUSIONS: Metal heads did not increase taper damage on CoCr trunnions compared with ceramic heads from the same hip design. The amount of material released at the taper junctions was very low when compared with available data regarding CoCr/Ti coupling in metal-on-metal bearings.Cite this article: A. Di Laura, H. Hothi, J. Henckel, I. Swiatkowska, M. H. L. Liow, Y-M. Kwon, J. A. Skinner, A. J. Hart. Retrieval analysis of metal and ceramic femoral heads on a single CoCr stem design. Bone Joint Res 2017;6:-350. DOI: 10.1302/2046-3758.65.BJR-2016-0325.R1.

Assessment of the equivalence of a generic to a branded femoral stem.

AIMS: The aim of this study was to compare the design of the generic OptiStem XTR femoral stem with the established Exeter femoral stem. MATERIALS AND METHODS: We obtained five boxed, as manufactured, implants of both designs at random (ten in total). Two examiners were blinded to the implant design and independently measured the mass, volume, trunnion surface topography, trunnion roughness, trunnion cone angle, Caput-Collum-Diaphyseal (CCD) angle, femoral offset, stem length, neck length, and the width and roughness of the polished stem shaft using peer-reviewed methods. We then compared the stems using these parameters. RESULTS: We found that the OptiStems were lighter (p < 0.001), had a rougher trunnion surface (p < 0.001) with a greater spacing and depth of the machined threads (p < 0.001), had greater trunnion cone angles (p = 0.007), and a smaller radius at the top of the trunnion (p = 0.007). There was no difference in stem volume (p = 0.643), CCD angle (p = 0.788), offset (p = 0.993), neck length (p = 0.344), stem length (p = 0.808), shaft width (p = 0.058 to 0.720) or roughness of the polished surface (p = 0.536). CONCLUSION: This preliminary investigation found that whilst there were similarities between the two designs, the generic OptiStem is different to the branded Exeter design. Cite this article: Bone Joint J 2017;99-B:310-16.

Clinically insignificant trunnionosis in large-diameter metal-on-polyethylene total hip arthroplasty.

OBJECTIVES: Mechanical wear and corrosion at the head-stem junction of total hip arthroplasties (THAs) (trunnionosis) have been implicated in their early revision, most commonly in metal-on-metal (MOM) hips. We can isolate the role of the head-stem junction as the predominant source of metal release by investigating non-MOM hips; this can help to identify clinically significant volumes of material loss and corrosion from these surfaces. METHODS: In this study we examined a series of 94 retrieved metal-on-polyethylene (MOP) hips for evidence of corrosion and material loss at the taper junction using a well published visual grading method and an established roundness-measuring machine protocol. Hips were retrieved from 74 male and 20 female patients with a median age of 57 years (30 to 76) and a median time to revision of 215 months (2 to 324). The reasons for revision were loosening of both the acetabular component and the stem (n = 29), loosening of the acetabular component (n = 58) and infection (n = 7). No adverse tissue reactions were reported by the revision surgeons. RESULTS: Evidence of corrosion was observed in 55% of hips. The median Goldberg taper corrosion score was 2 (1 to 4) and the annual rate of material loss at the taper was 0.084 mm3/year (0 to 0.239). The median trunnion corrosion score was 1 (1 to 3). CONCLUSIONS: We have reported a level of trunnionosis for MOP hips with large-diameter heads that were revised for reasons other than trunnionosis, and therefore may be clinically insignificant.Cite this article: H. S. Hothi, D. Kendoff, C. Lausmann, J. Henckel, T. Gehrke, J. Skinner, A. Hart. Clinically insignificant trunnionosis in large-diameter metal-on-polyethylene total hip arthroplasty. Bone Joint Res 2017;6:52-56. DOI: 10.1302/2046-3758.61.BJR-2016-0150.R2.

The effect of using components from different manufacturers on the rate of wear and corrosion of the head-stem taper junction of metal-on-metal hip arthroplasties.

AIMS: Surgeons have commonly used modular femoral heads and stems from different manufacturers, although this is not recommended by orthopaedic companies due to the different manufacturing processes. We compared the rate of corrosion and rate of wear at the trunnion/head taper junction in two groups of retrieved hips; those with mixed manufacturers (MM) and those from the same manufacturer (SM). MATERIALS AND METHODS: We identified 151 retrieved hips with large-diameter cobalt-chromium heads; 51 of two designs that had been paired with stems from different manufacturers (MM) and 100 of seven designs paired with stems from the same manufacturer (SM). We determined the severity of corrosion with the Goldberg corrosion score and the volume of material loss at the head/stem junction. We used multivariable statistical analysis to determine if there was a significant difference between the two groups. RESULTS: We found no significant difference in the corrosion scores of the two groups. The median rate of material loss at the head/stem junction for the MM and SM groups were 0.39 mm(3)/year (0.00 to 4.73) and 0.46 mm(3)/year (0.00 to 6.71) respectively; this difference was not significant after controlling for confounding factors (p = 0.06). CONCLUSION: The use of stems with heads of another manufacturer does not appear to affect the amount of metal lost from the surfaces between these two components at total hip arthroplasty. Other surgical, implant and patient factors should be considered when determining the mechanisms of failure of large diameter metal-on-metal hip arthroplasties. Cite this article: Bone Joint J 2016;98-B:917-24.

Are all metal-on-metal hip revision operations contributing to the National Joint Registry implant survival curves? : a study comparing the London Implant Retrieval Centre and National Joint Registry datasets.

AIMS: The National Joint Registry for England, Wales and Northern Ireland (NJR) has extended its scope to report on hospital, surgeon and implant performance. Data linkage of the NJR to the London Implant Retrieval Centre (LIRC) has previously evaluated data quality for hip primary procedures, but did not assess revision records. METHODS: We analysed metal-on-metal hip revision procedures performed between 2003 and 2013. A total of 69 929 revision procedures from the NJR and 929 revised pairs of components from the LIRC were included. RESULTS: We were able to link 716 (77.1%) revision procedures on the NJR to the LIRC. This meant that 213 (22.9%) revision procedures at the LIRC could not be identified on the NJR. We found that 349 (37.6%) explants at the LIRC completed the full linkage process to both NJR primary and revision databases. Data completion was excellent (> 99.9%) for revision procedures reported to the NJR. DISCUSSION: This study has shown that only approximately one third of retrieved components at the LIRC, contributed to survival curves on the NJR. We recommend prospective registry-retrieval linkage as a tool to feedback missing and erroneous data to the NJR and improve data quality. TAKE HOME MESSAGE: Prospective Registry - retrieval linkage is a simple tool to evaluate and improve data quality on the NJR.

Validation of primary metal-on-metal hip arthroplasties on the National Joint Registry for England, Wales and Northern Ireland using data from the London Implant Retrieval Centre: a study using the NJR dataset.

Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67,045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data.

Explicit finite element modelling of the impaction of metal press-fit acetabular components.

Metal press-fit cups and shells are widely used in hip resurfacing and total hip replacement procedures. These acetabular components are inserted into a reamed acetabula cavity by either impacting their inner polar surface (shells) or outer rim (cups). Two-dimensional explicit dynamics axisymmetric finite element models were developed to simulate these impaction methods. Greater impact velocities were needed to insert the components when the interference fit was increased; a minimum velocity of 2 m/s was required to fully seat a component with a 2 mm interference between the bone and outer diameter. Changing the component material from cobalt-chromium to titanium alloy resulted in a reduction in the number of impacts on the pole to seat it from 14 to nine. Of greatest significance, it was found that locking a rigid cap to the cup or shell rim resulted in up to nine fewer impactions being necessary to seat it than impacting directly on the polar surface or using a cap free from the rim of the component, as is the case with many commercial resurfacing cup impaction devices currently used. This is important to impactor design and could make insertion easier and also reduce acetabula bone damage.

Synthesis and antifungal potential of Co(II) complexes of 1-(2'-hydroxyphenyl) ethylideneanilines.

Synthesis of Co(II) complexes from 1-(2'-hydroxyphenyl)-ethylideneaniline and its N-phenyl derivatives has been described and their structures have been established on the basis of elemental analysis and IR studies. The complexes have been screened for their antifungal potential against Alternaria alternata, Fusarium oxysporum and Myrothecium roridum by spore germination inhibition method and the results are discussed.