Identifying The Pattern of Material Loss at the Head-Neck Junction Wear Helps Determine the Mechanism of Failure of Metal on Metal Total Hip Replacements

Material loss at the Head-Neck junction accounts for a third of the total volume material loss in contemporary metal-on-metal total hip replacements. It is speculated that the material loss is the result of corrosion and mechanical wear (fretting). High volumes of material loss have been reported, especially from the head taper. There is only one report on characterizing the pattern of material loss and this was in a very small number of cases (n=5). Our aim was to identify the different material loss patterns at the head taper and their corresponding mechanisms We retrospectively analysed a series of retrieved Large Head Metal on Metal Total Hip Replacements (155 cups, 155 femoral heads and 4 stems). We measured material loss on the bearing surfaces and the head-neck junction using well-published metrology methods. Furthermore we collected patient (age, gender and time of primary/revision operations), pre-revision (cobalt and chromium blood metal ion, oxford hip score, cup orientation and implant position) implant (cup and head size, manufacturer and corrosion severity) data. Finally we used surface analysis techniques (microscopy and spectroscopy) to identify fretting, imprinting and the material composition of debris. We devised a novel four-group classification and two blinded engineers classified the material loss patterns using wear maps derived from the metrology analysis We observed four distinct patterns of taper surface material loss at our retrieval centre and we set out to characterize these types and relate them to patient, implant and clinical variables. The four groups of material loss patterns were defined as: (1) Low wear (n= 63), (2) Open-end band (n=32), (3) Stripped material loss (n=54) and (4) Coup-Countercoup (n=6) (Figure). The Interobserver Reliability Kappa score was 0.78 (p<0.001) indicating substantial agreement between the two examiners. Analysis of variables between the groups identified significantly different head sizes (highest: Group 2, p=0.000), corrosion severity (highest: Group 2, p=0.004) and time to revision (highest: Group 3, p=0.040). We identified four different material loss patterns each with its own mechanism. Corrosion was identified as the principal mechanism in Groups 1 and 3. Group 1 head-neck junctions are thought to have a better seal with less fluid ingress in the junction. Group 3 head-neck junctions are attacked by corrosion either circumferentially, or unilaterally, along the whole engagement length. Mechanically assisted corrosion was the principal mechanism in Group 2. The higher friction torque opens up the open-end part of the junction and the ingressing fluid accelerates the corrosion. Extensive fretting was also observed under the scanning electron microscope. Intra-operative surgical damage was identified as the principal mechanism in Group 4, with only 6 components. The patterns and the mechanisms of material loss at the head-neck junction contribute to the understanding of large head metal-on-metal hip replacements. As a result, better implants can be designed in the future. Clinically, these findings suggest that head size and head taper-trunnion fit are the main factors that determine the longevity of the head-neck junction. On the other hand, patients selection does not influence the integrity of the junction

Material Loss at the Head Taper Junction of the Metal-on-Metal Pinnacle Total Hip Replacement

Introduction The ASR XL (DePuy) total hip replacement (THR) is a notable example of a modern metal-on-metal (MOM) implant design that has demonstrated unacceptable survival rates, leading to its recall by the manufacturer; national joint registries have reported revision rates at 7 years of 40% when paired with the Corail stem [1]. The ASR XL THR has a considerably greater risk of revision than the ASR resurfacing hip, which used the same bearing design. This suggests that material loss at the head-stem junction may be responsible for the greater percentage of THR failures observed in this design. The Pinnacle MOM-THR (DePuy) however used the same Corail stem as the ASR XL THR but demonstrated better clinical results, with revision rates of less than 10% at 7 years [1]. The ASR XL and MOM Pinnacle are two designs that have been widely used in hip replacement surgery. The reasons for the differences in the failure rates of the two designs are not fully understood. Comparing the mechanisms of failure of both hips will help surgeons understand whether patients with MOM Pinnacle hips will experience the same types of problems as with those seen with the ASR XL. The aims of this retrieval study were to investigate the significance of differences between the ASR XL and MOM Pinnacle in relation to: (1) pre-revision whole blood Co/Cr ratios, (2) visual evidence of taper corrosion, (3) volumetric material loss at the bearing surfaces and (4) volumetric material loss at the taper surfaces. Methods This study involved a series of failed MOM hips consisting of the ASR XL (n=30) and Pinnacle (n=30), all that had been used with a Corail stem. The bearing material in each design was cobalt-chromium and the Corail stem is of a cementless titanium 12/14 design. The ASR XL and Pinnacle had a median head diameter of 47mm (39-55) and 36mm (36-40) respectively, and a median time to revision of 38.5 months (12-74) and 55 months (14-86) respectively. Pre-revision whole blood metal ion levels were collected for each Table 1 summarises patient and implant data for the hips in this study. The female taper surfaces of all 60 heads were examined macroscopically and microscopically to assess the severity of corrosion. Each surface was graded with a score of between 1 (no corrosion) and 4 (severe corrosion) using a well-published scoring system, which has been shown to be statistically reliable. A Zeiss Prismo (Carl Zeiss Ltd, Rugby, UK) coordinate measuring machine (CMM) was used to determine the volume of material loss at the cup and head bearing surfaces. Up to 300,000 data points were collected using a 2mm ruby stylus that was translated along 400 polar scan lines on the surface. The raw data was used to map regions of material loss by comparing with the unworn geometry of the bearing. A Talyrond 365 (Hobson, Leicester, UK) roundness measuring machine was used to measure the volumetric material loss at each of the head taper surfaces. Published protocols were used to take a series of 180 vertical traces along the taper surface using a 5μm diamond stylus; worn and unworn regions were mapped and used to calculate material loss. Neither the volumetric measurement data nor corrosion scores were normally distributed. Therefore non-parametric tests were performed to assess the statistical significance of differences between the two designs in relation to the parameters under investigation in this study. Results Both the whole blood Co ion levels and the Co/Cr ratios, Figure 1, of the ASR XL hips were significantly greater than the Pinnacles (p<0.05). There was no significant difference between the whole blood Cr ion levels between the two designs (p=0.0542). 18 of the ASR XL hips presented evidence of edge wearing of the cup, compared with 14 Pinnacle hips; this difference was not significant (p=0.438). The length of the stem trunnion contact engagement length with the taper was approximated as being 10.5mm for both designs. The median time to revision of the ASR XL hips was significantly less than the Pinnacle hips (p<0.01). There was visual evidence of corrosion in 93% (n=28) and 90% (n=27) of head tapers for the ASR XLs and Pinnacles respectively. Moderate to severe corrosion was observed in 67% (n=20) of ASR XLs compared to 60% (n=18) of Pinnacles. There was however no statistically significant difference between the scores of the two groups (p=0.927). Figure 2 presents the distribution of material loss rates for the bearing and taper surfaces of the two designs in this study. The median total bearing surface (combined cup and head) rate of material loss for the ASR XL and Pinnacle hips was 4.45mm3/year (0.32-22.85) and 4.03mm3/year (0.87-62.12) respectively. There was no significant difference between the two groups (p=0.928). The median material loss rate at the taper surfaces of the ASR XL and Pinnacle hips was 0.62mm3/year (0-4.20) and 0.30mm3/year (0-3.12); this difference was not significant (p=0.198). Discussion The work of this study presents comparisons of retrieval findings between the ASR XL and Pinnacle MOM-THRs; these hip designs were two of the most commonly implanted in patients worldwide. The significantly greater whole blood Co/Cr ratios found in the ASR XL group compared to the Pinnacle group are of interest. It is speculated that a Co/Cr ratio of greater than 1 may be an indicator of corrosion of an implant whereby more Cr ions are retained on the surface, whilst comparatively more Co ions are released into the blood. In the current study we found wear rates at the bearing surfaces of both designs to be comparable, suggesting that the significantly greater Co/Cr ratios in the ASR XL hips must be due to greater corrosion at the taper junction than the Pinnacles. Although the ASR XL hips had been implanted for a significantly shorter period of time, our visual assessment of the corrosion of the taper junctions found that corrosion scores were comparable between the two designs; indeed, a marginally greater number of ASR XL tapers had evidence of moderate to severe corrosion. This finding, coupled with the elevated Co/Cr ratios suggests that the ASR XL design is more susceptible to corrosion at the taper junction than the Pinnacle hip. We found that the median rate of material loss at the ASR XL taper was over twice that of the Pinnacle taper. Whilst not statistically significant, this difference may be due to a greater risk of corrosion at this interface in the ASR XL design. The differences in material loss and corrosion that were observed at the taper junctions may be explained by considering the larger head sizes of the ASR XL hips in comparison to the Pinnacles. It has previously been shown that increasing head size is correlated with greater visual evidence of corrosion and that increased frictional torque along the taper junction due a larger head diameter can increase the risk of fretting-corrosion. It is suggested therefore that the combination of the larger head sizes of the ASR XLs coupled with the comparatively short, rough surface of the Corail trunnion results in a cumulative effect leading to greater corrosion at the taper junction. Significance The results of the study suggest that the combination of (1) increased frictional torque in the larger ASR XLs and (2) the rough Corail trunnion surface, results in greater corrosion at the taper junction in comparison to the Pinnacle hips; this helps to explain the higher risk of revision in this hip design

Rod Fracture in Magnetically Controlled Growing Spine Rods

Background: The mechanisms of fracture in magnetically controlled growing rods (MCGRs) and the risk factors associated with this are poorly understood. This retrospective analysis of explanted MCGRs aimed to add understanding to this subject. / Methods: From our cohort of over 120 retrieved MCGRs, we identified 7 rods that had fractured; all were single-rod constructs, retrieved from 6 patients. These were examined and compared with 15 intact single-rod constructs. Retrieval and fractographic analyses were used to determine the failure mode at the fracture site and the implant's functionality. Cobb angle, degree of rod contouring, and the distance between anchoring points were computed on anteroposterior and lateral radiographs. / Results: 5/7 versus 3/15 rods had been inserted after the removal of a previously inserted rod, in the fractured versus control groups. All fractured rods failed due to bending fatigue. Fractured rods had greater rod contouring angles in the frontal plane (P = 0.0407) and lateral plane (P = 0.0306), and greater distances between anchoring points in both anteroposterior and lateral planes (P = 0.0061 and P = 0.0074, respectively). / Conclusions: We found all failed due to a fatigue fracture and were virtually all single rod configurations. Fracture initiation points corresponded with mechanical indentation marks induced by the intraoperative rod contouring tool. Fractured rods had undergone greater rod contouring and had greater distances between anchoring points, suggesting that it is preferable to implant double rod constructs in patients with sufficient spinal maturity to avoid this complication

Morphometric analysis of patient-specific 3D-printed acetabular cups: a comparative study of commercially available implants from 6 manufacturers

Background 3D printed patient-specific titanium acetabular cups are used to treat patients with massive acetabular defects. These have highly porous surfaces, with the design intent of enhancing bony fixation. Our aim was to characterise these porous structures in commercially available designs. Methods We obtained 12 final-production, patient-specific 3D printed acetabular cups that had been produced by 6 manufacturers. High resolution micro-CT imaging was used to characterise morphometric features of their porous structures: (1) strut thickness, 2) the depth of the porous layer, (3) pore size and (4) the level of porosity. Additionally, we computed the surface area of each component to quantify how much titanium may be in contact with patient tissue. Statistical comparisons were made between the designs. Results We found a variability between designs in relation to the thickness of the struts (0.28 to 0.65 mm), how deep the porous layers are (0.57 to 11.51 mm), the pore size (0.74 to 1.87 mm) and the level of porosity (34 to 85%). One manufacturer printed structures with different porosities between the body and flange; another manufacturer had two differing porous regions within the body of the cups. The cups had a median (range) surface area of 756.5 mm2 (348 – 1724). Conclusions There is a wide variability between manufacturers in the porous titanium structures they 3D print. We do not currently know whether there is an optimal porosity and how this variability will impact clinically on the integrity of bony fixation; this will become clearer as post market surveillance data is generated

Statistical Shape Modelling of the Large Acetabular Defect in Hip Revision Surgery

The assessment of three-dimensional (3D) bony defects is important to inform the surgical planning of hip reconstruction. Mirroring of the contralateral side has been previously used to measure the hip centre of rotation (CoR). However, the contralateral side may not be useful when diseased or replaced. Statistical Shape Models (SSMs) can aid reconstruction of patient anatomy. Previous studies have been limited to computational models only or small patient cohorts. We used SSM as a tool to help derive landmarks that are often absent in hip joints of patients with large acetabular defects. Our aim was to compare the reconstructed pelvis with patients who have previously undergone hip revision. This retrospective cohort study involved 38 patients with Paprosky type IIIB defects. An SSM was built on 50 healthy pelvises and used to virtually reconstruct the native pelvic morphology for all cases. The outcome measures were the difference in CoR for 1) SSM vs diseased hip, 2) SSM vs plan and 3) SSM vs contralateral healthy hip. The median differences in CoR were 31.17 mm (IQ: 43.80 - 19.87 mm), 8.53 mm (IQ: 12.76 - 5.74 mm) and 7.84 mm (IQ: 10.13 - 5.13 mm), respectively. No statistical difference (p > 0.05) was found between the SSM vs plan and the SSM vs contralateral CoRs. Our findings show that the SSM model can be used to reconstruct the absent bony landmarks of patients with significant lysis regardless of the defect severity, hence aiding the surgical planning of hip reconstruction and implant design. This article is protected by copyright. All rights reserved

The analysis of defects in custom 3D‐printed acetabular cups: A comparative study of commercially available implants from six manufacturers

Three-dimensional (3D) printing is used to manufacture custom acetabular cups to treat patients with massive acetabular defects. There is a risk of defects occurring in these, often in the form of structural voids. Our aim was to investigate the presence of voids in commercially available cups. We examined 12, final-production titanium custom acetabular cups, that had been 3D-printed by six manufacturers. We measured their mass, then performed micro-computed tomography (micro-CT) imaging to determine their volume and density. The micro-CT data were examined for the presence of voids. In cups that had voids, we computed (1) the number of voids, (2) their volume and the cup volume fraction, (3) their sphericity, (4) size, and (5) their location. The cups had median mass, volume, and density of 208.5 g, 46,471 mm3, and 4.42 g/cm3, respectively. Five cups were found to contain a median (range) of 90 (58–101) structural voids. The median void volume and cup volume fractions of cups with voids were 5.17 (1.05–17.33) mm3 and 99.983 (99.972–99.998)%, respectively. The median void sphericity and size were 0.47 (0.19–0.65) and 0.64 (0.27–8.82) mm, respectively. Voids were predominantly located adjacent to screw holes, within flanges, and at the transition between design features; these were between 0.17 and 4.66 mm from the cup surfaces. This is the first study to examine defects within final-production 3D-printed custom cups, providing data for regulators, surgeons, and manufacturers about the variability in final print quality. The size, shape, and location of these voids are such that there may be an increased risk of crack initiation from them

The Performance of MAGEC X Spine Rods: A Comparative Retrieval Study

Study Design: Multicentre comparative analysis of explanted Spine Magnetically Controlled Growing Rods (MCGRs). Objectives: MAGEC X, the latest commercially available generation, was recalled in 2020 due to the risk of post-implantation separation of an actuator end-cap component. Currently, the supply of all MAGEC rods was temporarily suspended in the UK and the EU. Objective of this study is to compare the performance of the MAGEC X MCGR to the earlier MAGEC 1.3 design iteration, by means of retrieval analysis. Methods: Fifteen of both MAGEC X and MAGEC 1.3 rods were consecutively collected from five different hospitals following removal surgery and matched by time to removal. Clinical and implant data was collected for all MCGRs. Analysis comprised visual assessments of external damage, plain radiograph evaluations, force and elongation testing, MAGEC X end-cap torque testing and disassembly. Mann-Whitney U tests were used to statistically compare groups. Results: Rod distraction reached in vivo was significantly higher in the MAGEC 1.3 (P =.002). There was no statistically significant difference in the total external damage score (P =.870), maximum force produced (P =.695) or distraction reached during force test (P =.880). No pin fracture was detected. Elongation of stroke was mildly higher (P =.051) for the MAGEC X implants. One MAGEC X had evident end cap component loosening. Internal damage scores were mildly lower in the MAGEC X group. Conclusion: MAGEC X showed similar performance results than the previous design iteration MAGEC 1.3. End-cap component loosening was observed, with no major consequences on the internal mechanism

Comparative retrieval analysis of a novel anatomic tibial tray backside: alterations in tibial component design and surface coating can increase cement adhesions and surface roughness

Background: With the Persona® knee system a novel anatomic total knee design was developed, which has no pre-coating, whereas the predecessor knee system is pre-coated with polymethylmethacrylate (PMMA). Joint registry data have shown no decrease in risk of aseptic revision of PMMA pre-coated tibial components compared with non-pre-coated implants. The aim of this retrieval study was to compare the amount of cement adhesions, geometry and surface features between the two knee designs and to correlate them with the underlying reason for revision surgery. / Methods: Retrieval analysis was performed of 15 NexGen® and 8 Persona® fixed-bearing knee implants from the same manufacturer retrieved from two knee revision centres. A photogrammetric method was used to grade the amount of cement attached to the tibial tray backside. The geometry and dimensions of the tibial trays, tray projections and peripheral lips were measured using digital callipers and compared between the two different designs. To measure the surface roughness on the backside of the tibial tray, a contact profilometer was used. To investigate differences between the two designs statistical analyses (t-test) were performed. / Results: All Persona® trays showed evidence of cement adhesion with a % area of 75.4%; half of the NexGen® trays had cement adhesions, with a mean value of 20%. There was a significant difference in the percentage of area covered by cement between the two designs (p < 0.001). Results from the contact profilometer revealed that Persona® and NexGen® tray backsides showed a similar lateral (1.36 μm and 1.10 μm) and medial (1.39 μm and 1.12 μm) mean surface roughness with significant differentiation (p < 0.05) of the lateral and medial roughness values between the two designs. Persona® stems showed a significantly higher mean surface roughness (1.26) compared to NexGen® stems (0.89; p < 0.05). / Conclusion: The novel anatomic knee system showed significantly more cements adhesions and a higher surface roughness which was most likely attributed to the most obvious design and coating alteration of the tibial tray. This study provides first retrieval findings of a novel TKA design recently introduced to the market

Characterisation of wear areas on UHMWPE total knee replacement prostheses through study of their areal surface topographical parameters

Total knee replacement is one of the most common elective surgeries in the world, and presents a number of challenges related to the wear of ultra-high molecular weight polyethylene (UHMWPE). This paper presents an analysis of the surface topographical properties of the worn and unworn condylar surfaces on a small cohort of both wear simulated and retrieved prostheses of varying designs. A number of measurement points were taken on each prostheses in a mixture of worn and unworn areas through the use of focus-variation microscopy (FVM), a non-contact method of surface measurement. Surface areal parameters were extracted from this data to analyse and search for patterns within the data. It was found that in general, worn implant surfaces appear to show smoother, less peak dominated surfaces than unworn area. It was also found that wear simulated and retrieved implants display similar characteristics of surface topography. In addition, variation was noted between different designs of TKR device, with posterior stabilised designs found to be peak dominated and cruciate retaining type implants being valley dominated