Does diametrical clearance influence the wear of Pinnacle hip implants?

Aims: The optimum clearance between the bearing surfaces of hip arthroplasties is unknown. Theoretically, to minimize wear, it is understood that clearances must be low enough to maintain optimal contact pressure and fluid film lubrication, while being large enough to allow lubricant recovery and reduce contact patch size. This study aimed to identify the relationship between diametrical clearance and volumetric wear, through the analysis of retrieved components. / Methods: A total of 81 metal-on-metal Pinnacle hips paired with 12/14 stems were included in this study. Geometrical analysis was performed on each component, using coordinate and roundness measuring machines. The relationship between their as-manufactured diametrical clearance and volumetric wear was investigated. The Mann-Whitney U test and unpaired t-test were used, in addition to calculating the non-parametric Spearman's correlation coefficient, to statistically evaluate the acquired data. / Results: The hips in this study were found to have had a median unworn diametrical clearance of 90.31 μm (interquartile range (IQR) 77.59 to 97.40); 32% (n = 26) were found to have been below the manufacturing tolerance. There was no correlation found between clearance and bearing (rs = -0.0004, p = 0.997) or taper (rs = 0.0048, p = 0.966) wear rates. The wear performance of hips manufactured within and below these specifications was not significantly different (bearing: p = 0.395; taper: p = 0.653). Pinnacles manufactured from 2007 onwards had a greater prevalence of bearing clearance below tolerance (p = 0.004). / Conclusion: The diametrical clearance of Pinnacle hips did not influence their wear performance, even when below the manufacturing tolerance. The optimum clearance for minimizing hip implant wear remains unclear

Quantifying material loss from the bearing surfaces of retrieved hip replacements: Method validation

Computational methods used to quantify wear in failed hip arthroplasties are often limited by human and sampling errors. An automated software solution has been developed to overcome these shortcomings. The overarching aim of the current study was to validate this method through a comparison with gravimetric measurements. Seventy-two different wear volumes were quantified to within a mean error of 0.14 mm3 and 0.10 mm3 of gravimetric results for simulated cup and head components, respectively. This approach had an improved accuracy, repeatability and reproducibility over a commonly used, commercially available software solution, which bears many of the common sources of error

Dimensional analysis of 3D-printed acetabular cups for hip arthroplasty using X-ray microcomputed tomography

Purpose Three-dimensional (3D) printing is increasingly used to produce orthopaedic components for hip arthroplasty, such as acetabular cups, which show complex lattice porous structures and shapes. However, limitations on the quality of the final implants are present; thus, investigations are needed to ensure adequate quality and patients safety. X-ray microcomputed tomography (micro-CT) has been recognised to be the most suitable method to evaluate the complexity of 3D-printed parts. The purpose of this study was to assess the reliability of a micro-CT analysis method comparing it with reference systems, such as coordinate measuring machine and electron microscopy. Design/methodology/approach 3D-printed acetabular components for hip arthroplasty (n = 2) were investigated. Dimensions related to the dense and porous regions of the samples were measured. The micro-CT scanning parameters (voltage – kV, current – µA) were optimised selecting six combinations of beam voltage and current. Findings Micro-CT showed good correlation and agreement with both coordinate measuring machine and scanning electron microscopy when optimal scanning parameters were selected (130 kV – 100 µA to 180 kV – 80 µA). Mean discrepancies of 50 µm (± 300) and 20 µm (± 60) were found between the techniques for dense and porous dimensions. Investigation method such as micro-CT imaging may help to better understand the impact of 3D printing manufacturing technology on the properties of orthopaedic implants. Originality/value The optimisation of the scanning parameters and the validation of this method with reference techniques may guide further analysis of similar orthopaedic components

The in vivo location of edge-wear in hip arthroplasties : combining pre-revision 3D CT imaging with retrieval analysis

AIMS: Acetabular edge-loading was a cause of increased wear rates in metal-on-metal hip arthroplasties, ultimately contributing to their failure. Although such wear patterns have been regularly reported in retrieval analyses, this study aimed to determine their in vivo location and investigate their relationship with acetabular component positioning. METHODS: 3D CT imaging was combined with a recently validated method of mapping bearing surface wear in retrieved hip implants. The asymmetrical stabilizing fins of Birmingham hip replacements (BHRs) allowed the co-registration of their acetabular wear maps and their computational models, segmented from CT scans. The in vivo location of edge-wear was measured within a standardized coordinate system, defined using the anterior pelvic plane. RESULTS: Edge-wear was found predominantly along the superior acetabular edge in all cases, while its median location was 8° (interquartile range (IQR) -59° to 25°) within the anterosuperior quadrant. The deepest point of these scars had a median location of 16° (IQR -58° to 26°), which was statistically comparable to their centres (p = 0.496). Edge-wear was in closer proximity to the superior apex of the cups with greater angles of acetabular inclination, while a greater degree of anteversion influenced a more anteriorly centred scar. CONCLUSION: The anterosuperior location of edge-wear was comparable to the degradation patterns observed in acetabular cartilage, supporting previous findings that hip joint forces are directed anteriorly during a greater portion of walking gait. The further application of this novel method could improve the current definition of optimal and safe acetabular component positioning. Cite this article: Bone Joint Res 2021;10(10):639-649

Analysis of retrieved STRYDE nails

AIMS: The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices. METHODS: We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions. RESULTS: All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate - severe junction corrosion. CONCLUSION: We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: Bone Jt Open 2021;2(8):599-610

Mechanical wear analysis helps understand a mechanism of failure in retrieved magnetically controlled growing rods: a retrieval study

BACKGROUND: To assess the relationship between mechanical wear and the failure of the internal lengthening mechanism in retrieved MAGnetic Expansion Control (MAGEC) growing rods. METHODS: This study included 34 MAGEC rods retrieved from 20 patients. The state of the internal mechanism and mechanical wear were assessed in all the rods using plain radiographs and visual inspection. Metrology was then performed to assess the topography and mechanical wear of the telescopic bars, using a Talyrond 365 (Taylor Hobson, Leicester, UK) roundness measuring machine. RESULTS: Plain radiographs showed evidence of a broken internal mechanism in 29% of retrieved rods. Single-side wear marks were found in 97% of retrieved rods. Material loss was found to significantly increase in rods with a damaged internal mechanism (p < 0.05) and rods with longer time in situ (r = 0.692, p < 0.05). CONCLUSIONS: We found an association between damage to the internal mechanism of the rods and (1) patterns of single-side longitudinal wear marks and (2) increased material loss. As the material loss was also found to increase over time of rod in situ, we emphasise the importance of early detection and revision of failed MAGEC rods in clinical practice

Quantifying the bearing surface wear of retrieved hip replacements

© 2019 Biosurface and Biotribology.All right reserved. Accurate quantification of bearing material loss from retrieved metal-on-metal (MOM) hip replacements is key to understanding their failure. Geometric methods are currently the only means of estimating volumetric wear from retrieved implants and numerous contrasting approaches to obtain these measures have been published. Data collection strategies have been thoroughly discussed and refined to minimise the effect of error incurring factors; however, there is an opportunity to optimise the current methods of estimating the pre-wear geometry and, therefore, improve the accuracy of wear volume measurements. An automated analysis strategy to quantify volumetric wear is proposed in this study, which utilises the entire bearing surface to determine the implants pristine geometry. This involves the iterative removal of geometrically effected data points to optimise the fit and size of a perfect sphere. Once fitted, this reference geometry is compared with the measured data, in its entirety, to calculate the volume change representative of the quantity of material lost. Improving the reliability of this parameter could influence the care of a million patients that remain with MOM hip implants. Rigorous validation of this method will dominate future work, ensuring that the accuracy and reliability of this approach are sufficient to provide clinically meaningful data

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

Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Background: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. Methods: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation.Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. Discussion: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. Trial registration: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014