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Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 70 - 70
1 Apr 2019
Van Citters D Currier B Titus A Currier J
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Introduction. Wear of polyethylene tibial inserts has been cited as being responsible for up to 25% of revision surgeries, imposing a very significant cost burden on the health care system and increasing patient risk. Accurate measurement of material loss from retrieved knee bearings presents difficult challenges because gravimetric methods are not useful with retrievals and unworn reference dimensions are often unavailable. Geometry and the local anatomy restrict in vivo radiographic wear analysis, and no large-scale analyses have illuminated long-term comparative wear rates and their dependence on design and patient factors. Our study of a large retrieval archive of knee inserts indicates that abrasive/adhesive wear of polyethylene inserts, both on the articular surface and on the backside of modular knees is an important contributor to wear, generation of debris and integrity of locking geometry. The objective of the current study is to quantify wear performance of tibial inserts in a large archive of retrieved knees of different designs. By assessing wear in a large and diverse series, the goal is to discern the effect on wear performance of a number of different factors: patient factors that might help guide treatment, knee design factors and bearing material factors that may inform a surgeon's choice from among the array of arthroplasty device options. Methods. An IRB approved retrieval database was queried for TKA designs implanted between 1997 and 2017. 1385 devices from 5 TKA designs were evaluated. Damage was ranked according to Hood's method, oxidation was determined through FTIR, and wear was determined through direct measurement of retrieved inserts using a previously established protocol. Design features (e.g. materials, conformity, locking mechanisms, stabilization, etc.) and patient demographics (e.g. age, weight, BMI, etc.) were cataloged. Multivariate analysis was performed to isolate factors contributing to wear, oxidation, and damage. Results. Wear and oxidation were both found to scale with time in vivo in conventional and crosslinked polyethylene. Wear rate was also found to scale with time in vivo, but was not found to be a function of oxidation. Regression shows patient age and female sex to correlate negatively with wear rate. Polished trays, crosslinked polyethylene, and constrained knee designs are all correlated with decreased wear rates. Discussion. While this study indicates that loosening and infection are predominant causes for TKA revision, wear related failure remains common. We believe this to be the largest existing comparative study of modern TKA wear rates. Insert wear is shown to correlate with several patient factors. Wear performance also varies significantly between knee designs, polyethylene material choice and tray surface finish. When compared to a historical standard for knee wear rates, all designs evaluated in the current study exhibited significant improvements in wear rates. Retrieval analysis can provide insight into implant and patient related factors that contribute to knee wear, with the goal of improving patient outcomes and best matching design decisions to patient populations


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 105 - 105
1 Dec 2013
Zietz C Kluess D Fabry C Baum F Mittelmeier W Bader R
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Current implant designs and materials provide a high grade of quality and safety, but aseptic implant loosening is still the main reason for total hip revision. Highly cross-linked polyethylene (HX-PE) is used successfully in total hip replacements (THR) since several years. The good wear properties lead to a reduction of wear debris and may contribute to a longer survival time of the THRs. Furthermore, thin HX-PE liner allows the use of larger femoral heads associated with a decreased risk of dislocation and an improved range of motion. However, the cross-linking process is associated with a loss of mechanical properties of the polyethylene material which compromise the use of thin HX-PE liner in terms of high stress situations. The aim of the present study was the experimental wear analysis of HX-PE liner under steep acetabular cup position. Furthermore, a finite element analysis (FEA) was performed in order to calculate the stress within the HX-PE material in case of steep cup position under physiological loading. Experimental wear testing was performed for 5 Mio load cycles, using highly cross-linked polyethylene (HX-PE) acetabular liner combined with 44 mm ceramic femoral heads at a standard position of the acetabular cup (30° inclination) according to ISO 14242 as well as at 60° cup inclination. The wall thickness of the HX-PE liner was 3.8 mm. A hip wear simulator, according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany), was used and wear was determined gravimetrically. Moreover, finite element models of the THR system at standard and steep cup position was created by Abaqus/CAE (Dessault Systemes Providence, USA). Using the finite element software Abaqus (Dessault Systemes Providence, USA) the total hip implants were physiologically loaded with maximum force of the gait cycle (3.0 kN). Thereby, the stresses within the HX-PE material were analysed. The average gravimetrical wear rates of the HX-PE liners at standard implant position (30°) and 60° cup inclination showed small wear amounts of 3.15 ± 0.32 mg and 1.92 ± 1.00 mg per million cycles, respectively. The FEA revealed a clear increase of stresses at the HX-PE liner with respect to steep cup position (von Mises stress of 8.78 MPa) compared to ISO standard implant position (von Mises stress of 5.70 MPa). The wear simulator tests could not demonstrate significant differences of gravimetrical wear amount of HX-PE liners under steep hip cup position compared to standard implant position. The small contact surface between the femoral head and the SX-PE liner during the wear testing may lead to the low wear rate of the misaligned acetabluar cup. Moreover, the FEA showed that the effect of a misaligned acetabular cup on the stresses within the polyethylene liner can be critical. Although an increase of wear could not be detected a steeper acetabular cup position using thin HX-PE liners should be avoided due to higher stresses preventing implant failure in clinical application


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 186 - 186
1 Mar 2013
Jassim S Patel S Wardle N Tahmassebi J Middleton R Shardlow D Stephen A Hutchinson J Haddad F
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Introduction

In Total Hip Arthroplasty (THA), polyethylene wear reduction is key to implant longevity. Oxidized Zirconium (OxZi) unites properties of a ceramic bearing surface and metal head, producing less wear in comparison to standard Cobalt-Chromium (CoCr) when articulating with Cross-linked polyethylene (XLPE) in vitro. This study investigates in vivo polyethylene (PE) wear, outcomes and complications for these two bearing couples in patients at 5 year follow-up

Methods

400 patients undergoing THA across four institutions were prospectively randomised into three groups. Group I received a cobalt-chrome (CoCr) femoral head/ cross-linked polyethylene (XLPE) liner; Group II received an OxZi femoral head/ ultrahigh molecular weight polyethylene (UHMWPE) liner; Group III received an OxZi femoral head/XLPE liner. All bearing heads were 32 mm. Linear wear rate was calculated with Martell computer software. Functional outcome and complications were recorded.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 306 - 306
1 Mar 2013
Ranawat A Meftah M Klingenstein G Yun RJ Ranawat CS
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Introduction. Ceramic femoral heads have superior scratch resistant with better wettability and improved wear characteristics compared to metal heads in the laboratory setting. The objective of this study was to compare long-term in vivo wear rates of ceramic and metal femoral heads against conventional polyethylene articulation with cementless stems in young, active patients. Materials and Methods. Thirty-one matched pair of alumina and metal (Cr-Co) femoral heads against conventional polyethylene in young patients (between 45 and 65 years old) were analyzed for wear and failures for mechanical reasons. The match was based on gender and age at the time of surgery. All procedures were performed between June 1989 and May 1992 by a single surgeon via posterolateral approach, using cementless RB (Ranawat-Bernstein) stems, HG II (Harris-Galante) cups, 4150 conventional polyethylene and 28 mm femoral heads. Hospital for Special Surgery (HSS) hip score was used for clinical analysis. Wear measurements were performed between the initial anteroposterior standing pelvis radiographs, at a minimum of one year after the index procedure to eliminate the effect of bedding-in period, and the latest follow-up. Two independent observers analyzed polyethylene wear rates using the computer-assisted Roman 1.70 software. In revision cases, the wear rates were calculated from radiographs prior to revision surgery. A pair student t test was performed to analyze the statistical difference. Two-tailed ρ values less than 0.05 were considered statistically significant. Results. The mean age was 54.5 ± 8.5 at the time of surgery (range 23.3–65). Average clinical and radiographic follow-up were 17 ± 2.1 (range 12.8–20) and 14.1±2.6 years (range 10–19.1) respectively. The mean HSS score in ceramic and metal groups were 30.4 ± 8 (range 24–56) and 36.6 ± 4.7 (range 20–40) respectively. The mean wear rate for the ceramic group and the metal group were 0.086 ± 0.046 mm/year and 0.137 ± 0.052 mm/year, respectively which was statistically significant (p < 0.001). There were no revisions in the ceramic group for osteolysis or loosening, however one patient required a strut graft for femoral osteolysis that was distal to the tip of the implant due to non-circumferential porous coating of the stem. There were 3 cup revisions in the metal group, all for acetabular osteolysis, and no stem lysis or loosening. Discussion and Conclusion. The low mean wear rate of ceramic compared to metal in this study is consistent with previously published laboratory reports. There was no revision for loosening or osteolysis in the ceramic group, which demonstrates superior durability compared to metal femoral heads. The strength of this study is that this is the first long-term report comparing ceramic and metal femoral heads against conventional polyethylene with cementless stems using a matched pair analysis in young patients


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_2 | Pages 63 - 63
1 Feb 2020
Darwish O Langhorn J Van Citters D Metcalfe A
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Introduction. Patella implant research is often overlooked despite its importance as the third compartment in a total knee replacement. Wear and fracture of resurfaced patellae can lead to implant failure and revision surgeries. New simulation techniques have been developed to analyze the performance of patella designs as they interact with the trochlear groove in total knee components, and clinical validation is sought to ensure that these simulations are appropriate. The objective of this work was to subject several patellar designs to patient-derived deep knee bend (DKB) inputs on a 6 degree of freedom (DOF) simulator and compare the resultant wear scars to clinical retrievals. Materials and Methods. Previously reported DKB profiles were developed based on in vivo patellofemoral data and include a wide range of patient variability. The profiles chosen for this body of work were based on the stress in the patellar lateral facet; maximizing this stress whilst maintaining the ability to run the profile stably on the simulator. Load/kinematic profiles were run on three patellar designs (n=3 per group) for 220,000 cycles at 0.8Hz on an AMTI VIVO joint simulator. A comparison cohort of clinically retrieved devices of the same design was identified in an IRB-approved database. Exclusion criteria included gross delamination, cracking secondary to oxidation, and surgeon-reported evidence of malalignment leading to mal-tracking. 29 Patellae were included for analysis: PFC. ®. All Poly (n=14), ATTUNE. ®. Anatomic (n=6), and ATTUNE. ®. Medialized Dome (n=9). Mean in vivo duration was 70.1 months. Patellae were analyzed under optical microscope in large-depth-of-field mode to map the surface damage profile. Burnishing ‘heat-maps’ were generated for retrievals and simulated patellae by normalizing the patellar size and overlaying silhouettes from each component of the same type using a custom-developed MatLAB code. Results. Burnishing heat-map comparisons between retrievals and simulator specimens for each of the three designs were compared. Retrievals show more variation than simulator devices, however the general loci and relative area of burnished regions is closely aligned for each of the three designs. The retrieved and simulated burnishing scar heat-maps on all-poly PFC. ®. patellae are centered medio-laterally with a wider profile on the lateral aspect. The burnishing marks are continuous. A similar observation may be made of the ATTUNE. ®. medialized dome, retrievals and simulator specimens, though the contact areas appear to be more concentrated away from the apex. The anatomic patellae show two primary regions of contact, and minimal burnishing at the apex. The simulator specimens likewise show two principal regions of contact. Discussion. Wear scar analysis shows that joint simulation on AMTI VIVO yields clinically relevant wear patterns across a variety of device types. Clinically relevant damage provides insight that load and motion inputs to the simulator deliver results that may be used to interpret in vivo performance or analyze future designs and/or materials. This qualitative surface contact analysis will help to inform future quantitative mass loss and fatigue failure studies. For any figures or tables, please contact authors directly


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 152 - 152
1 Sep 2012
Reinders J Sonntag R Nadorf J Bitsch R Rieger JS Kretzer JP
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Background. Polyethylene (PE) as a bearing material for total joint replacements (TJR) represents the golden standard for the past forty years. However, over the past decade it becomes apparent that PE wear and the biological response to wear products are the limiting factor for the longevity of TJRs. For this reason research has focused onto PE wear particle analysis. A particle analysis highly depends on the methodological work and results often show discrepancies between different research groups. From there, our hypothesis was, that an often unattended influencing factor is the optical magnification which has been used for particle analyses. Material and Methods. In the present study samples of a previous conducted knee wear simulator test were used. Wear particles were isolated from the bovine serum using an established method. 1. Briefly the serum was digested with hydrochloric acid and a continuous stirring and heating. Particles were filtered onto 20nm alumina filters and analyzed using high resolution field emission gun scanning electron microscopy (FEG-SEM). Filters were analyzed on the same points using three different magnifications: 5000, 15000 and 30000. To describe the size and morphology of the particles the equivalent circle diameter (ECD), aspect ratio (AR), roundness (R) and form factor (FF) were specified according to ASTM F 1877-05. The estimated total number (ETN) of particles was calculated based on the number of particles recovered on the filter, the analyzed area, the dilution, evaporation and the total serum volume. Results. The results showed significant differences between the different magnifications. Examples of the analyzed pictures are depicted in Fig. 1. The results are summarized in Tab. 1. In particular the size of the particles highly depends on the choosen optical magnification which becomes apparent in a more than twofold increase when comparing wear particles at magnification of 5k or 30k (p≤0.001). The mean particle diameter distribution (Fig. 2) also shows a shift in the distribution of wear particles: A higher magnification results in a higher fraction of smallest particles (e.g. over 50 percent between 0–0.2µm with magnification 30.000 compared to only 3 percent with a magnification of 5.000) and nearly no particles above 1µm could be verified. The results regarding the particle morphology show smaller but significant differences. The ETN of particles quadruplicates when comparing results with magnifications of 5.000 and 30.000. Conclusion. This study shows great differences in particle size, which can be directly attributed to the differences in optical magnification. According to ASTM F1877-05 a magnification of 10.000 for the analysis of wear particles between 0.1–1µm is recommended. However, results show that this magnification is not sufficient especially for particle sizes below 0.2µm, which account for the greatest number of particles. To the authors opinion a more detailed recommendation concerning the magnification is needed. Additional, a standardized evaluation system which takes the magnification into account is necessary to allow comparison of different research groups


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 96 - 96
1 Apr 2019
Wang D Amis A
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Background

Medical advances and an ageing population mean that more people than ever rely on artificial joints. In the past years, shoulder joint replacement has developed rapidly and the numbers of shoulder prostheses implanted increased dramatically. Wear is one of the main contributors to the failure of shoulder implants. It is therefore important to measure the wear properties of the articulating surfaces within the joint in vitro. Investigation of wear characteristics through a comprehensive range of motion using a sophisticated shoulder simulator would reveal the durability of the material, the performance of component design and the safety analyses of prostheses. The purpose of the work was to develop and validate a multi-station shoulder simulator, which could accurately simulate physiological gleno-humeral forces and displacements during activities of daily living.

Materials and Methods

Imperial shoulder simulator was designed with six articulating stations and one loaded soak control station for anatomical shoulder system wear simulation. It gives an adduction-abduction (AA) range of-15° to 55°, flexion-extension (FE) range of −90° to 90° and internal external rotation (IER) range of 15° to −90°. The rotations are applied simultaneously to the humeral implants by using stepper motors with integral position encoders. Axial and shear loadings to each glenoid implant were applied using pneumatic cylinders. Force controlled translations were recorded using load cells and LVDTs, and a data acquisition system. Pneumatic cylinders were also installed to work to counterbalance weights during the motion of adduction-abduction. All bearing pairs are within isolated and sealed test chambers to prevent loss of fluid through evaporation, and cross contamination of third body wear (as recommended in F1714-96). The simulator is controlled by LabVIEW program allowing to reproduce shoulder activities of daily living.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 51 - 51
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction. The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998 and femoral heads larger than 32mm in diameter introduced 2004. The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against large diameter femoral heads at a minimum of 10 years follow-up. Methods. Two centers contributed patients to this ongoing clinical study. Inclusion criteria for patients was: primary THR; femoral heads greater than 32mm; minimum 10 year follow-up. 69 hips have been enrolled with an average follow-up of 11.2 years (10–15), 32 females (50%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis. Results. Wear analysis: Using the average of the slopes of the individual regression lines, the wear rate was 0.004±0.094mm/yr. Using the early to latest film method, the wear rate was 0.035±0.076mm/yr. Radiographic analysis: Acetabular side: the greatest incidence of radiolucency occurred in zone 1 at 27%; sclerotic lines had a less than 2% incidence in any of the 3 zones; there was no identified osteolysis. Femoral side: the highest incidence of radiolucencies was in zones 1 and 3, 7% and 4%; sclerotic lines were rare in any zone, maximum in zone 3, 4%; there was no identified osteolysis. Conclusion. The wear of this form of irradiated and melted highly crosslinked polyethylene remained at levels lower than the detection limit of the software at minimum 10 year follow-up and there was no identified osteolysis


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 52 - 52
1 Feb 2017
Bragdon C Barr C Berry D Della Valle C Garvin K Johanson P Clohisy J Malchau H
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Introduction. The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998. Numerous publications have reported reduced wear rates and a reduction in particle induced peri-prosthetic osteolysis at short to mid-term follow-up. The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and wear analysis of patients receiving this form of highly crosslinked polyethylene articulating against 32mm femoral heads or less at a minimum of 13 years follow-up. Methods. Inclusion criteria for patients was a primary THR with femoral heads 32mm or less and a minimum 13 year follow-up. 139 hips have been enrolled with an average follow-up of 13.7 years (13–16), 80 females (57%). Wear analysis was performed using the Martell Hip Analysis software. Radiographic grading was performed on the longest follow-up AP hip films. The extent of radiolucency in each zone greater than 0.5mm in thickness was recorded along with the presence of sclerotic lines and osteolysis. Results. Wear analysis: Using the average of the slopes of the individual regression lines, the wear rate was 0.006±0.033mm/yr. Using the early to latest film method, the wear rate was 0.003±0.056mm/yr. Radiographic analysis: Acetabular side: the greatest incidence of radiolucency occurred in zone 1 at 21%; sclerotic lines had a less than 2% incidence in any of the 3 zones; there was no identified osteolysis. Femoral side: the incidence of radiolucencies was limited to zone 1, 2%; sclerotic lines were rare in any zone, maximum in zone 3, 4%; there was no identified osteolysis. Conclusion. The wear of this form of irradiated and melted highly crosslinked polyethylene remained at levels lower than the detection limit of the software at minimum 13 year follow-up and there was no identified osteolysis


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 17 - 17
1 Dec 2013
Bolland B Gardner E Roques A Maul C Culliford D Zeineh N O'Hara L
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This study reports the mid-term results of a large bearing uncemented metal on metal total hip replacement (MOMHTHR) matched series using the Synergy stem and Birmingham modular head in 36 hips (mean follow up 61 months). All patients underwent clinical, metal ion and MRI assessment. Wear analysis was performed on retrieved heads using Redlux non-contact optical profilometry. Seven patients (19%) have undergone revision surgery. All revisions had two or more of either symptoms, high metal ions or an MRI suggestive of an adverse reaction to metal debris (ARMD). There was no evidence of component malposition or impingement. Frank staining of tissues together with high volume dark brown fluid collections were found in all cases. All stems and cups were well fixed. In 4 cases pubic and ischial lysis (adjacent to the inferior fins) was observed. All 7 cases had radiological, intraoperative and histological evidence of ARMD (Figure 1). The failure cohort had significantly higher whole blood cobalt ion levels and OHS (p = 0.001), but no significant difference in cup size (p = 0.77), gender predominance, stem offset or cup position (p = 0.12). Sleeves had been used in all revision cases. Wear analysis (n = 4) demonstrated increased wear at the trunnion/sleeve interface in a distribution compatible with micromotion (Figure 2). There was normal wear at the articulating surface. This series further demonstrates unacceptable failure rates in LHMOMTHR in a series where a compatible stem for the BHR modular head was used. Use of a CoCr sleeve within a CoCr head taper appears to contribute to abnormal wear and therefore potential ARMD and subsequent failure


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 3 - 3
1 Sep 2012
Langton D Ghandi J Sidaginamale R Mereddy P Joyce T Lord J Natu S Nargol A
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Introduction. We conducted independent wear analysis of retrieved metal on metal (MoM) hip components from around the world. All patients with resurfaced hips who developed adverse reactions to metal debris (ARMD) were found to have increased wear of the bearing surfaces. This was untrue in patients with large diameter (?36mm) MoM total hip replacements. This led us to search for other factors leading to ARMD. Methods. MoM THR explants retrieved from 78 patients suffering ARMD underwent full volumetric wear analysis of bearing surface and taper-junctions using coordinate measuring machine. Scanning electron microscopy (SEM) used to characterise material composition of specific areas. Results. 34 MoM THRs were found to have relatively low bearing surface wear (< 3mm. 3. /year). In each of these cases, material loss up to 60 microns wear depth was identified on the internal taper-junctions of femoral components. However, volumetric loss was rarely >5mm. 3. Similarly only 65% of metal ion levels of these patients were found to be greater than the MHRA guidance figure (7µg/L). Patterns of material loss at the tapers were consistent with antero-posterior force splaying open the taper-junction. This characteristic pattern was identified in number of commercially available devices (titanium and cobalt chromium stems). Soft tissue lesions were severe in patients found to have taper damage. Histology confirmed severe ALVAL with lymphoid neogenesis in majority cases, suggesting that wear debris from taper junctions may have greater potential to stimulate adverse immune response. Discussion. The results suggest that forces transmitted from large diameter hard-on-hard bearing surfaces are sufficient to cause mechanical damage to modular junctions with secondary localised corrosion. We urge caution in the use of these designs and recommend a re-evaluation of the stem head interface


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 97 - 97
1 Jun 2012
Hussain A Packer K Li C Kamali A
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Introduction. All hip replacements depend upon good orientation and positioning to ensure that implants function well in vivo. Mal-orientated devices can lead to poor patient gait, poor range of motion, impingement, edge loading and high wear, which in turn may result in the premature failure of the implants. Aim. To investigate the correlation between edge loading and wear on retrieved implants through linear wear analysis and radiographic examination of implants in vivo. Materials & Methods. 55 BHR retrieved acetabular cups with known times in vivo were examined. Linear wear analysis was conducted using a Taylor-Hobson Talyrond 290 roundness machine. Edge loaded cups were classified as cups which showed the wear area crossing over the edge of the cup. Non-edge loaded devices were devices with the wear area within the articulating sphere of the cup, Figure 1. The maximum deviation of the profile from an ideal circle was taken as the maximum linear wear. The implant orientation angles for one edge loaded acetabular component was determined by superimposing BHR models, generated by ProEngineer Wildfire 4 with ISDX II extension software, onto frontal x-ray images, Figure. 2. Results. In this study 32 cups were classed as edge loaded and 23 classed as non-edge loaded. Non-edge loaded cups had a linear wear rate of 1.48±1.01 μm/year. Edge loaded cups generated a significantly higher linear wear rate of 24.02±22.72 μm/year than non-edge loaded devices. For the device analysed radiographically, the inclination was 62° and version angle was 16°. The inclination angle of this device is outside the recommended inclination angle for the BHR and would be considered as mal-orientated. The linear wear result showed that the device was edge loaded with a wear rate of 22.25 μm/year. Discussion/Conclusion. This study aimed to find a correlation between edge loading and high wear of retrieved devices. The results in this study show that edge loaded bearings generate significantly higher linear wear rates compared to the non-edge loaded group. The devices in the edge loaded group also showed a greater scatter with unpredictable linear wear


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 60 - 60
1 May 2016
Mueller U Reinders J Kretzer J
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Introduction. Temporary use of antibiotic-impregnated polymethylmethacrylate (PMMA) bone cement spacers in two-stage revisions is considered to be standard of care for patients with a chronic infection of a joint replacement. Spacers should be wear resistant and load-bearing to avoid prolonged immobilisation of the patient and to reduce morbidity. Most cement spacers contain barium sulphate or zirconium dioxide as radio-opaque substrate. Both are quite hard materials that may negatively influence the wear behaviour of the spacer. Calcium carbonate is another radio-opaque substrate with lower hardness potentially increasing the wear resistance of the spacer materials. The purpose of the study was to compare a prototype PMMA knee spacer (calcium carbonate loaded) with a commercially available spacer (containing barium sulphate) regarding the wear performance and particle release in a knee wear simulator. Material and Methods. Spacer K (TECRES, Italy) was used as barium sulphate (10%) containing spacer material. A prototype material (Heraeaus Medical, Germany) with 15% calcium carbonate was compared. Both were gentamicin impregnated, ready-made for clinical application (preformed) and consist of a tibial and a femoral component. Force-controlled simulation was carried out on an AMTI knee simulator. The test parameters were in accordance to ISO 14243–1 with a 50% reduced axial force (partial weight bearing). Tests were carried out at 37 °C in closed chambers filled with calf serum. Tests were run for 500,000 cycles at a frequency of 1 Hz. For wear analysis, gravimetric wear measurements according to ISO 14243–2 and wear particle analysis according to ASTM F1877–05 were performed. Results. Fig. 1 presents the results of the gravimetric wear measurements. For the Spacer K cement a mean articular wear mass of 375.53±161.22 mg was determined after 500.000 cycles (femoral components: 149.55±17.30 mg, tibial components: 225.98±153.01 mg). The prototype cement showed lower mean total wear of 136.32±37.58 mg (femoral components: 74.32±33.83 mg, tibial components: 61.99±15.74 mg). However, a statistically significant lower wear rate was only seen for the femoral components (p=0,027). In Fig. 2 isolated PMMA wear particles are shown and the morphological characteristics are given in Tab. 1. Discussion and conclusion. The prototype material showed better wear performance in terms of gravimetric wear and particle release. Thus calcium carbonate seems to be a promising material as radio-opaque substrate in PMMA spacers. Nevertheless, the wear amount released from both spacer materials is much higher as compared to conventional total knee replacements with polyethylene inserts. In this context biological reactions against PMMA particles and an increased release of cytokines have been reported in vitro [1] and furthermore, the promotion of osteolysis has been shown in vivo in the presence of PMMA particles [2]. As a clinical consequence we suggest excessive debridement during removal of the cement spacer components to reduce the risk of third body wear for the final joint replacement. Beside the wear performance further studies are essential to prove the mechanical stability and the antibiotic release kinetics for the prototype cement


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 113 - 113
1 Feb 2020
Wimmer M Ngai V Kunze J Cip J Laurent M Jacobs J
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Introduction. Ideally, standardized wear testing protocols replicate the in vivo motions and forces of TKR patients. In a previous study with 30 TKR patients, two distinct in vivo gait patterns emerged, one characterized as having low anteroposterior (AP-L) motion and the other high anteroposterior (AP-H) motion. The aim of this study was to determine the effect of the two in vivo-determined gait patterns on total and backside insert wear in comparison with the ISO standard 14243-3. In order to differentiate and accurately quantify topside and backside wear, a novel technique was employed where different lanthanide tracers are incorporated into the polyethylene during manufacture. Materials and Methods. Components from the Zimmer NexGen CR Knee Replacement System were used. Europium (Eu) and Gadolinium (Gd)-stearates were mechanically mixed with GUR1050 UHMWPE resin to obtain two tracer-UHMWPE resins containing 49.1±1.5 ppm Eu and 68.8±1.6 ppm Gd, respectively. 12 grams of the Eu-doped resin was placed on the bottom, 10 grams of virgin GUR1050 resin was placed in the middle, and 10 grams of Gd-doped resin was placed on the top to mold NexGen CR tibial inserts. The backside was then machined to interlock with the tibial baseplate. The minimum insert thickness was 10 mm. All inserts were packaged in nitrogen and gamma sterilized. The wear test was conducted on a 4-station knee simulator in displacement-control mode. Simulator input was obtained from ISO 14243-3 and from gait of 30 NexGen TKR subjects, previously categorized into low (AP-L) and high (AP-H) anteroposterior motion groups. Per station, each insert was sequentially subjected to ISO, AP-L, AP-H motion for 2 Mc at 1 Hz. Subsequently, the ISO profile was repeated. Tibial inserts were weighed and lubricant samples were taken after every 0.5 Mc interval. Knowing the Eu and Gd concentrations from ICP-MS analysis, and normalizing those to the concentrations in the polyethylene inserts, the localized (Eu – backside; Gd – topside) wear was calculated. Wear particle analysis was conducted following established protocols. Results. For all tested liners (n=4 + soak) during the three tested motion profiles, the chemically calculated wear correlated closely with the gravimetrically determined wear (R. 2. »0.8), with slopes not different from 1. Both in vivo motion groups displayed higher wear rates than the ISO group following the order of the AP motion amplitudes (Figure). Backside wear for ISO constituted 2.76% ± 0.90% (mean ± SE) of the total wear, increasing significantly to 15.8 ± 3.2% for AP-L and further increasing to 19.3 ± 0.95% for AP-H (p<.001). The mean wear particle sizes were under 200 nm for all three motion patterns, being largest for the AP-H gait protocol (Table). Discussion. Both in vivo motion groups displayed higher wear rates than the group tested per ISO standard 14243-3. Interestingly backside wear was affected the most and increased 4.5 to 6-fold over ISO. Testing for the proportion of backside wear across various activities of daily living may therefore be an important consideration in evaluating knee prostheses wear and could be facilitated by this new tracer technology. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 6 - 6
1 Mar 2017
Mell S Fullam S Wimmer M Lundberg H
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Generic walking profiles applied to mechanical knee simulators are the gold standard in wear testing of total knee replacements (TKRs). Recently, there was a change in the international standard (ISO) for knee wear testing (ISO 14243-3): the direction of motion in the anterior/posterior (AP) and internal/external (IE) directions were reversed. The effects of this change have not been investigated, therefore it is not known whether results generated by following this new standard can be compared to historical wear tests which used the old standard. Using a finite element analysis (FEA) model of a TKR in parallel with an energy based wear model and adaptive remeshing, we investigated differences in wear between the newest ISO standard developed in 2014, and the previous ISO standard developed in 2004. CAD models of a left sided NexGen Cruciate Retaining (CR) TKR (Zimmer, Warsaw, IN) were used to create the FEA model (Figure 1). The loads and motions specified by simulator standards ISO 14243-3(2004) and ISO 14243-3(2014) were applied to the model. Analyses were run using ABAQUS v6.13-2 Standard (Dassault Systèmes, Waltham, MA). 8 node hexahedral elements were used to model the UHMWPE component. The contact was modeled as penalty contact, with the friction coefficient set to 0.04 on the articular surface. The cobalt chromium molybdenum femoral component was modeled as a rigid surface, utilizing a mix of 2. nd. order quadrilaterals and tetrahedrons. Wear of the polyethylene (PE) component was predicted to 1,000,000 cycles using a previously published frictional energy-based wear model. The wear model, developed from data generated in wheel-on-flat tests, utilizes two parameters defining the frictional energy required to remove a unit volume of material both parallel (3.86E8 J/mm. 3. ) and perpendicular (3.55E7 J/mm. 3. ) to the primary polyethylene fibril direction. Primary fibril direction for the analysis was set to the AP direction. Wear for each simulation of a gait cycle was scaled to 500,000 cycles. Two gait cycles were simulated representing 1,000,000 cycles in total. Adaptive remeshing was driven by the wear model, with the mesh being updated every time increment to simulate material ablation. The time step size was variable with a maximum of 0.01s. The FEA predicted higher wear rates for the newest ISO standard (7.34mg/million cycles) compared to the previous standard (6.04mg/million cycles) (Figure 2). Comparing the predicted wear scars (Figure 3), the new version of the standard covered a larger percentage of the total articular surface, with wear being more spread out as opposed to localized. This is more similar to what is seen in patient retrievals. The results of the study suggest that major differences between the old and the new ISO standard exist and therefore historical wear results are not comparable to newly obtained results. In addition, this study demonstrates the utility of FEA in wear analysis, though the wear model needs further work and validation before it can be used as a supplement to simulator testing. Validation of the wear model against simulator tests and pin-on-disk experiments is currently underway. For figures/tables, please contact authors directly.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_21 | Pages 61 - 61
1 Dec 2016
Gascoyne T Parashin S Turgeon T Bohm E Laende E Dunbar M
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Articulation of the polyethylene (PE) insert between the metal femoral and tibial components in total knee replacements (TKR) results in wear of the insert which can necessitate revision surgery. Continuous PE advancements have improved wear resistance and durability increasing implant longevity. Keeping up with these material advancements, this study utilises model-based radiostereometric analysis (mbRSA) as a tool to measure in vivo short-term linear PE wear to thus predict long-term wear of the insert. Radiographic data was collected from the QEII Health Sciences Centre in Halifax, NS. Data consisted of follow-up RSA examinations at post-operative, six-, 12-, and 24-month time periods for 72 patients who received a TKR. Implanted in all patients were Stryker Triathlon TKRs with a fixed, conventional PE bearing of either a cruciate retaining or posterior stabilised design. Computer-aided design (CAD) implant models were either provided by the manufacturer or obtained from 3D scanned retrieved implants. Tibial and femoral CAD models were used in mbRSA to capture pose data in the form of Cartesian coordinates at all follow-ups for each patient. Coordinate data was manually entered into a 3D modeling software (Geomagic Studio) to position the implant components in virtual space as presented in the RSA examinations. PE wear was measured over successive follow-ups as the linear change in joint space, defined as the shortest distance between the tibial baseplate and femoral component, independently for medial and lateral sides. A linear best-fit was applied to each patient's wear data; the slope of this line determined the annual wear rate per individual patient. Wear rates were averaged to provide a mean rate of in vivo wear for the Triathlon PE bearing. Mean linear wear per annum across all 72 patients was 0.088mm/yr (SD: 0.271 mm/yr) for the medial condyle and 0.032 mm/yr (SD: 0.230 mm/yr) for the lateral condyle. Cumulative linear wear at the 2-year follow-up interval was 0.207mm (SD: 0.565mm) and 0.068mm (SD: 0.484mm) for the medial and lateral condyles, respectively. Linear PE wear measurements using mbRSA and Geomagic Studio resulted in 0.056mm/yr additional wear on the medial condyle than the lateral condyle. Large standard deviations for yearly wear rates and cumulative measurements demonstrate this method does not yet exhibit the accuracy needed to provide short-term in vivo wear measurement. Inter-patient variability from RSA examinations is likely a source of error when dealing with such small units of measure. Further analysis on patient age and body mass index may eliminate some variability in the data to improve accuracy. Despite high standard deviations, the results from this research are in proximity to previously reported linear wear measurements 0.052mm/yr and 0.054mm/yr. Linear wear analysis will continue upon completion of >100 patients, in addition to volumetric PE wear over the entire articulating surface


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 555 - 555
1 Dec 2013
Teeter M Pang H Naudie D McCalden RW MacDonald S
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Purpose. The objective of this study was to compare the wear characteristics and damage scores in highly crosslinked (XLPE) and conventional polyethylene (CPE) acetabular liners. Methods. This was a retrieval analysis of 13 XLPE liners obtained from patients who underwent revision surgery from 1999 to 2011. These patients were matched on patient demographics (age, BMI, side, sex, and length of implantation) and implant characteristics (inner diameter, outer diameter, and lip angle) to another group with CPE who underwent revision in the same time period. The only difference between implants was the use of XLPE. Wear analysis was performed with micro-computed tomography (micro-CT), provided thickness measurements across four quadrants of the bearing surface. Surface damage was scored and the pattern documented. The mean duration of implantation was 5.00 ± 3.36 years in the XLPE group and 5.19 ± 3.69 years in the CPE group (p = 0.12), with the longest duration exceeding 10 years. Results. CPE demonstrated more wear at time of retrieval with a mean thickness of 8.18 ± 1.50 mm compared to XLPE with a mean thickness of 8.91 ± 1.76 mm (p < 0.001). Damage scoring was not significantly different between the two groups, with a total damage score of 13.77 ± 3.95 in XLPE and 15.23 ± 4.63 in CPE (p = 0.18). There was no difference in the distribution of wear and damage. Conclusion. XLPE undergoes less wear than CPE, however this may not be apparent by using damage scoring alone, which is the most common retrieval analysis technique. The superior wear properties of XLPE may reduce the need for revision surgery as a result of decreased wear and osteolysis


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 28 - 28
1 Jan 2013
Langton D Sidaginamale R Lord J Joyce T Natu S Nargol A
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Background. Previous studies have suggested that the modular junction of metal on metal (MoM) total hip replacements (THR) is an important source of metallic debris. Methods. We carried out a prospective study using custom techniques to analyse one of the largest collections of failed contemporary MoM devices in the world. All explants from patients who had suffered adverse reactions to metal debris (ARMD) were included in this study. These explants included: 82 36mm THRs, and 147 resurfacing head THRs and 140 resurfacing arthroplasties from several manufactures. Volumetric wear analysis of the bearing surfaces and taper junctions was carried out using a coordinate measuring machine. The relationships between total metallic loss and metal ion concentrations and the macroscopic and histological tissue appearance of THR patients were compared to those in resurfacing patients. Mann Whitney test for non-parametric data was used to assess significant differences between groups. Results. Resurfacing explants retrieved from patients who had suffered ARMD were found to have significantly higher median rates of volumetric wear than the THRs (10.16 versus 2.25mm. 3. /yr (p < 0.001)). Total volumetric material loss from taper junctions ranged from 0.01 to 21.55mm. 3. When volumetric taper wear was combined with bearing surface wear in the THR patients this total rate of material loss was still significantly less than in the resurfacing patients 2.52 versus 10.16mm. 3. /yr (p < 0.001)). Despite this, macroscopic tissue destruction and extent of ALVAL infiltration was found to be significantly greater in the THR patients. Conclusion. Taper debris appears to more readily stimulate a destructive immune cascade than debris from primary bearing surfaces. This cascade can culminate in catastrophic tissue necrosis when blood metal ion concentrations appear normal. MHRA guidance should distinguish clearly between MOM THRs and resurfacings


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 4 - 4
1 Sep 2012
Bolland B Culliford D Langton D Millington J Arden N Latham J
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This study reports the mid-term results of a large bearing hybrid metal on metal total hip replacement (MOMHTHR) in 199 hips (185 patients) with mean follow up of 62 months. Clinical, radiological, metal ion and retrieval analysis were performed. Seventeen patients (8.6%) had undergone revision, and a further fourteen are awaiting surgery (defined in combination as failures). Twenty one (68%) failures were females. All revisions and ten (71%) awaiting revision were symptomatic. Twenty four failures (86%) showed progressive radiological changes. Fourteen revision cases showed evidence of adverse reactions to metal debris (ARMD). The failure cohort had significantly higher whole blood cobalt ion levels (p=0.001), but no significant difference in cup size (p=0.77), inclination (p=0.38) or cup version (p=0.12) compared to the non revised cohort. Female gender was associated with increased risk of failure (p=0.04). Multifactorial analysis demonstrated isolated raised Co levels in the absence of symptoms or XR changes were not predictive of failure (p=0.675). However the presence of pain (p<0.001) and XR changes (p<0.001) in isolation were significant predictors of failure. Wear analysis (n=5) demonstrated increased wear at the trunnion/head interface (mean out of roundness measurements 34.5 microns (normal range 8–10 microns) with normal wear levels at the articulating surfaces. Macroscopically corrosion was evident at the proximal and distal stem surfaces. Cumulative survival rate, with revision for any reason was 92.4% (95%CI: 87.4–95.4) at 5 years. Including those awaiting surgery, the revision rate would be 15.1% with 89.6% (95% CI: 83.9–93.4). Cumulative survival at 5 years. This MOMHTHR series has demonstrated unacceptable high failure rates with evidence of high wear at the head/trunnion interface and passive corrosion to the stem surface. Female gender was an independent risk factor of failure. Metal ion levels remain a useful aspect of the investigation work up but in isolation are not predictive of failure


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 19 - 19
1 Mar 2013
Bolland B Tilley S Tilley C Cook R Latham J
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Pseudotumour formation is being reported with increasing frequency in failing metal-on-metal hip resurfacings and replacements. This mode of failure complication has also been reported with metal-on-polyethylene bearing bearings when it is usually associated with evidence of surface corrosion and no apparent wear at the head–neck taper. We present a case with evidence of taper wear and damage secondary to corrosion in an uncemented total hip replacement with a metal on polyethylene articulation (TMZF (Titanium, Molybdenum, Zirconium and Ferrous) Accolade® stem, Trident® HA coated acetabular shell, Low Friction Ion Treatment (LFIT™) Cobalt-Chrome anatomic head (40 mm), X3® polyethylene liner). Case. A 69 year old woman had a THR in 2008. A year later she started to complain of lateral based hip pain. Clinical examination and initial imaging indicated trochanteric bursitis and heterotopic bone formation. The symptoms became worse over the next 3 years and the patient was listed for exploration and excision of heterotopic bone. Surgical findings. Extensive pseudotumour was encountered deep to bursa and adherent to capsule. Abductors, external rotators and vastus lateralis were spared. There was minimal calcar osteolysis and marginal erosion in superior acetabulum. There was no obvious wear on the articulating surfaces of the femoral head and polyethylene inlay of the socket nor was there any evidence of neck-to-rim impingement or edge loading. There was visible blackening of both the taper and trunnion after femoral head removal. Results. Peripheral blood samples taken at the time of surgery recorded Cobalt 107 nmol/L, Chromium 9 nmol/L. Wear Measurements. These were performed on the articulating surfaces and the head taper using the RedLux Artificial Hip Profiler. No discernable wear was noted at the articulating surfaces. Qualitative 3-D surface mapping demonstrated a trunnion imprint on head taper of 10.1 mm in length. At the distal end of the taper this was incomplete indicating possible taper/trunnion incongruity. The majority of the material loss was demonstrated at the proximal end on the polar opposite side to incomplete imprint (Figure 1). Corrosion analysis. The head was sectioned for more detailed surface analysis of areas of interest. This demonstrated a polished region just inside the taper (G), followed by a deep pit (F), a region of extensive pitting (E) and running along the taper length were longitudinal needle like pits (D) indicative of a path of fluid ingress (D-G ref Fig 2.). These findings were more suggestive of crevice corrosion than mechanical wear. Histology. There was evidence of aseptic lymphocytic vasculitis-associated lesion (ALVAL) scoring 8 out of 10 (as per Campbell et al). With the continuing increase in the use of larger head sizes the findings of pseudotumour formation and taper damage in a commonly used hip replacement raises considerable concern. Wear analysis has highlighted that although there is evidence of motion occurring at the taper / trunnion interface, corrosion appears to be the dominant mechanism of damage to the taper. In addition to the use of larger head sizes this case also raise concerns about the compatibility of certain metal alloy combinations