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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 15 - 15
2 May 2024
Williams S Smeeton M Isaac G Anderson J Wilcox R Board T Williams S
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Dual Mobility (DM) Total Hip Replacements (THRs), are becoming widely used but function in-vivo is not fully understood.

The aim of this study was to compare the incidence of impingement of a modular dual mobility with that of a standard cup.

A geometrical model of one subject's bony anatomy \[1\] was developed, a THR was implanted with the cup at a range of inclination and anteversion positions (Corail® stem, Pinnacle® cup (DePuy Synthes)). Two DM variants and one STD acetabular cup were modelled. Joint motions were taken from kinematic data of activities of daily living associated with dislocation \[2\] and walking. The occurrence of impingement was assessed for each component combination, orientation and activity. Implant-implant impingement can occur between the femoral neck and the metal or PE liner (DM or STD constructs respectively) or neck-PE mobile liner (DM only).

The results comprise a colour coded matrix which sums the number of impingement events for each cup position and activity and for each implant variant.

Neck-PE mobile liner impingement, occurred for both DM sizes, for all activities, and most cup placement positions indicating that the PE mobile liner is likely to move at the start of all activities including walking.

For all constructs no placement positions avoided neck-metal (DM) or neck-PE liner (STD) impingementevents in all activities. The least number of events occurred at higher inclination and anteversion component positions. In addition to implant-implant impingement, some instances of bone-bone and implant-bone impingement were also observed.

Consistent with DM philosophy, neck-PE mobile liner impingement and liner motion occurred for all activities including walking. Neck-liner impingement frequency was comparable between both DM sizes (metal liner) and a standard cup (PE liner).


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 14 - 14
7 Jun 2023
Smeeton M Wilcox R Isaac G Anderson J Board T Van Citters DW Williams S
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Dual Mobility (DM) Total Hip Replacements (THRs) were introduced to reduce dislocation risk, which is the most common cause of early revision. The in-vivo mechanics of these implants is not well understood, despite their increased use in both elective and trauma settings. Therefore, the aim of this study was to comprehensively assess retrieved DM polyethylene liners for signs of damage using visual inspection and semi-quantitative geometric assessment techniques.

Retrieved DM liners (n=20) were visually inspected for the presence of seven established modes of polyethylene damage. If embedded debris was identified on the external surface, its material composition was characterised using energy-dispersive x-ray analysis (EDX). Additionally, each liner was geometrically assessed for signs of wear/deformation using a validated methodology.

Visual inspection of the liners revealed that scratching and pitting were the most common damage modes on either surface. Burnishing was observed on 50% and 15% of the internal and external surfaces, respectively. In addition, embedded debris was identified on 25% of the internal and 65% of the external surfaces. EDX analysis of the debris identified several materials including iron, titanium, cobalt-chrome, and tantalum. Geometric analysis demonstrated highly variable damage patterns across the liners.

The results of this study provide insight into the in-vivo mechanics of DM bearings. For example, the results suggest that the internal bearing (i.e., between the head and liner) acts as the primary articulation site for DM-THRs as evidenced by a higher incidence of burnishing and larger, more concentrated regions of penetration across the liners’ internal surfaces. Furthermore, circumferential, and crescent-shaped damage patterns were identified on the articulating surfaces of the liners thus providing evidence that these components can rotate within the acetabular shell with varying degrees of mobility. The mechanics of DM bearings are complex and may be influenced by several factors (e.g., soft tissue fibrosis, patient activities) and thus further investigation is warranted.

Finally, the results of this study suggest that DM liners may be susceptible to ex-vivo surface damage and thus caution is advised when handling and/or assessing these types of components.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 69 - 69
4 Apr 2023
Smeeton M Wilcox R Isaac G Anderson J Board T Van Citters D Williams S
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Dual mobility (DM) total hip replacements (THRs) were introduced to reduce dislocation risk, which is the most common cause of early revision. Although DM THRs have shown good overall survivorship and low dislocation rates, the mechanisms which describe how these bearings function in-vivo are not fully understood. Therefore, the study aim was to comprehensively assess retrieved DM polyethylene liners for signs of damage using visual inspection and semi-quantitative geometric assessment methods.

Retrieved DM liners (n=18) were visually inspected for the presence of surface damage, whereby the internal and external surfaces were independently assigned a score of one (present) or zero (not present) for seven damage modes. The severity of damage was not assessed. The material composition of embedded debris was characterised using energy-dispersive x-ray analysis (EDX). Additionally, each liner was geometrically assessed for signs of wear/deformation [1].

Scratching and pitting were the most common damage modes on either surface. Additionally, burnishing was observed on 50% of the internal surfaces and embedded debris was identified on 67% of the external surfaces. EDX analysis of the debris identified several materials including titanium, cobalt-chrome, iron, and tantalum. Geometric analysis demonstrated highly variable damage patterns across the liners.

The incidence of burnishing was three times greater for the internal surfaces, suggesting that this acts as the primary articulation site. The external surfaces sustained more observable damage as evidenced by a higher incidence of embedded debris, abrasion, delamination, and deformation. In conjunction with the highly variable damage patterns observed, these results suggest that DM kinematics are complex and may be influenced by several factors (e.g., soft tissue fibrosis, patient activities) and thus further investigation is warranted.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_4 | Pages 9 - 9
1 Apr 2022
Williams S Pryce G Board T Isaac G Williams S
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The 10 year survivorship of THR is generally over 95%. However, the incidence of revision is usually higher in year one. The most common reason being dislocation which at least in part is driven by inadequate range of motion (ROM) leading to impingement, subluxation and ultimately dislocation which is more frequently posterior. ROM is affected by patient activity, bone and component geometry, and component placement. To reduce the incidence of dislocation, supported by registry data, there has been an increase in the use of so-called ‘lipped’ liners. Whilst this increases joint stability, the theoretical ROM is reduced. The aim of this study was to investigate the effect of lip placement on impingement.

A rigid body geometric model was incorporated into a CT scan hemi-pelvis and femur, with a clinically available THR virtually implanted. Kinematic activity data associated with dislocation was applied, comprising of five posterior and two anterior dislocation risk activities, resulting from anterior and posterior impingement respectively. Cup inclination and anteversion was varied (30°-70°, 0°-50° respectively) to simulate extremes of clinical outcomes. The apex position of a ‘lipped’ liner was rotated from the superior position, anteriorly and posteriorly in steps of 45°. Incidence and location of implant and bone impingement was recorded in 5346 cases generated.

A liner with the lip placed superior increased the occurrence of implant-implant impingement compared with a neutral liner. Rotation of the lip from superior reduced this incidence. This effect was more marked with posterior rotation which after 90° reduced anterior impingement to levels similar to a neutral liner. Complete inversion of the lipped liner reduced impingement, but this and anterior rotation both negate its function – additional stability.

This study comprises one bone geometry and component design and one set of activity profiles. Nevertheless, it indicates that appropriate lip placement can minimise the likelihood of impingement for a range of daily activities whilst still providing additional joint stability.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 17 - 17
1 Dec 2021
Shuttleworth M Vickers O Isaac G Culmer P Williams S Kay R
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Abstract

Objectives

Dual mobility (DM) hip implants whereby the polyethylene liner is “free-floating” are being used increasingly clinically. The motion of the liner is not well understood and this may provide insight into failure mechanisms; however, there are no published methods on tracking liner motion while testing under clinically relevant conditions. The aim was to develop and evaluate a bespoke inertial tracking system for DM implants that could operate submerged in lubricant without line-of-sight and provide 3D orientation information.

Methods

Trackers (n=5) adhered to DM liners were evaluated using a robotic arm and a six-degree of freedom anatomical hip simulator. Before each set of testing the onboard sensor suites were calibrated to account for steady-state and non-linearity errors. The trackers were subjected to ranges of motion from ±5° to ±25° and cycle frequencies from 0.35Hz to 1.25Hz and the outputs used to find the absolute error at the peak angle for each principle axis. In total each tracker was evaluated for ten unique motion profiles with each sequence lasting 60 cycles.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_16 | Pages 18 - 18
1 Dec 2021
Brown M Wilcox R Isaac G Anderson J Board T Williams S
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Abstract

OBJECTIVES

Dual mobility (DM) total hip replacements (THRs) were introduced to reduce the risk of hip dislocation in at-risk patients. DM THRs have shown good overall survivorship and low rates of dislocation, however, the mechanisms which describe how these bearings function in-vivo are not fully understood. This is partly due to a lack of suitable characterisation methodologies which are appropriate for the novel geometry and function of DM polyethylene liners, whereby both surfaces are subject to articulation. This study aimed to develop a novel semi-quantitative geometric characterisation methodology to assess the wear/deformation of DM liners.

METHODS

Three-dimensional coordinate data of the internal and external surfaces of 14 in-vitro tested DM liners was collected using a Legex 322 coordinate measuring machine. Data was input into a custom Matlab script, whereby the unworn reference geometry was determined using a sphere fitting algorithm. The analysis method determined the geometric variance of each point from the reference surface and produced surface deviation heatmaps to visualise areas of wear/deformation. Repeatability of the method was also assessed.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 42 - 42
1 Mar 2021
Williams S Jones A Wilcox R Isaac G Traynor A Board T Williams S
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Abstract

Objectives

Impingement in total hip replacements (THRs), including bone-on-bone impingement, can lead to complications such as dislocation and loosening. The aim of this study was to investigate how the location of the anterior inferior iliac spine (AIIS) affected the range of motion before impingement.

Methods

A cohort of 25 CT scans (50 hips) were assessed and nine hips were selected with a range of AIIS locations relative to the hip joint centre. The selected CT Scans were converted to solid models (ScanIP) and THR components (DePuy Synthes) were virtually implanted (Solidworks). Flexion angles of 100⁰, 110⁰, and 120⁰ were applied to the femur, each followed by internal rotation to the point of impingement. The lateral, superior and anterior extent of the AIIS from the Centre of Rotation (CoR) of the hip was measured and its effect on the range of motion was recorded.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 49 - 49
1 Apr 2017
Lancaster-Jones O Al-Hajjar M Thompson J Isaac G Fisher J
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Background

Many factors contribute to the occurrence of edge-loading conditions in hip replacement; soft tissue tension, surgical position, patient biomechanical variations and type of activities, hip design, etc. The aim of this study was to determine the effect of different levels of rotational and translational surgical positioning of hip replacement bearings on the occurrence and severity of edge-loading and the resultant wear rates.

Method

The Leeds II Hip-Joint Simulator and 36mm diameter alumina matrix composite ceramic bearings (BIOLOX delta, DePuy Synthes, UK) were used in this study. Different levels of mismatch between the reconstructed rotational centres of the head and the cup were considered (2, 3 and 4mm) in the medial-lateral axis. Two cup inclination angles were investigated; an equivalent to 45 and 65 degrees in-vivo, thus six conditions (n=6 for each condition) were studied in total with three million cycles completed for each condition. The wear of the ceramic-on-ceramic bearings were determined using a microbalance (Mettler Toledo, XP205, UK) and the dynamic microseparation displacement was measured using a Liner Variable Differential Transformer.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 60 - 60
1 Mar 2017
Lancaster-Jones OO Al-Hajjar M Williams S Jennings L Thompson J Isaac G Fisher J
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Introduction and Aims

Clinically many factors such as variations in surgical positioning, and patients' anatomy and biomechanics can affect the occurrence and severity of edge loading which may have detrimental effect on the wear and durability of the implant. Assessing wear of hundreds of combinations of conditions would be impractical, so a preclinical testing approach was followed where the occurrence and severity of edge loading can be determined using short biomechanical tests. Then, selected conditions can be chosen under which the wear can be determined. If a wear correlation with the magnitude of dynamic separation or the severity of edge loading can be shown, then an informed decision can be made based upon the biomechanical results to only select important variables under which the tribological performance of the implant can be assessed. The aim of this study was to determine the relationship between the wear of ceramic-on-ceramic bearings and the (1) magnitude of dynamic separation, (2) the maximum force reached during edge loading and (3) the severity of edge loading resulting from component translational mismatch between the head and cup centres.

Methods

The Leeds II hip joint simulator with a standard walking cycle and 36mm diameter ceramic-on-ceramic bearings (BIOLOX® delta, DePuy Synthes Joint Reconstruction, Leeds, UK.) were used. The study was in two parts. Part one: a biomechanical study where the dynamic separation, the maximum load during edge loading, and the duration of edge loading alongside the magnitude of forces under edge loading (severity of edge loading) were assessed. Part two; a wear study where the wear rates of the bearing surfaces were assessed under a series of input conditions. These input testing conditions included inclining the acetabular cups at 45° and 65° cup inclination angle (in-vivo equivalent), with 2, 3, and 4mm medial-lateral component mismatch between the centres of the head and the cup. This equated to six conditions being assessed, each with three repeats for the biomechanical test, and six repeats completed for the wear study.

The severity of edge loading was assessed as described in Equation 1.

Severity of Edge Loading = ∫tt0 F(x) dx + ∫tt0 F(y) dy … Equation 1,

where F(x) is the axial load, F(y) is the medial-lateral load and t-t0 is the duration of edge loading.

The wear of the ceramic bearings were determined using gravimetric analysis (XP205, Mettler Toledo, UK).


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 61 - 61
1 Mar 2017
Lancaster-Jones OO Al-Hajjar M Williams S Jennings L Thompson J Isaac G Fisher J
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Introduction and Aims

There are many variables that can affect the occurrence and severity of edge loading in hip replacement. A translational mismatch between the centres of rotation of the head and cup may lead to dynamic separation, causing edge loading and increased wear. Combining a steep inclination angle with such translational mismatch in the medial-lateral axis caused a larger magnitude of separation and increased severity of edge loading. Previous studies have shown variation in the hip Swing Phase Load (SPL) during gait between different patients. The aim of this study was to apply a translational mismatch and determine the effect of varying the SPL on the occurrence and severity of edge loading under different cup inclination angles in a hip joint simulator.

Methods

The Leeds II hip joint simulator with a standard gait cycle and 36mm diameter ceramic-on-ceramic bearings (BIOLOX® delta) were used in this study. The study was in two stages; [1] a biomechanical study where the magnitude of dynamic separation, the duration of edge loading and the magnitude of force under edge loading (severity) were assessed under variations in component positioning and SPLs. [2] A wear study to assess edge loading with selected input conditions. For the biomechanical study, a combination of four mismatches, three cup inclination angles, and eight SPLs (Table 1) were investigated. For the wear study, three SPL conditions were selected with one cup angle and one mismatch (Table 1). Three million cycles were completed under each condition. Mean wear rates and 95% confidence limits were determined and statistical analysis (one way ANOVA) completed (significance taken at p<0.05).

Table 1: Study matrix


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 13 - 13
1 Feb 2017
Ali M Al-Hajjar M Thompson J Isaac G Jennings L Fisher J
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Introduction

Variations in component position can lead to dynamic separation and edge loading conditions. In vitro methods have been developed to simulate edge loading conditions and replicate stripe wear, increased wear rate, and bimodal wear debris size distribution, as observed clinically [1, 2]. The aim of this study was to determine the effects of translational and rotational positioning on the occurrence of dynamic separation and severity of edge loading, and then investigate the wear rates under the most severe separation and edge loading conditions on an electromechanical hip joint simulator.

Materials and Methods

A hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter ceramic-on-ceramic (BIOLOX®delta, PINNACLE®, DePuy Synthes, UK) hip replacements. Three axes of rotation conditions (ISO 14242-1 [3]) was applied to the femoral head. This study was in two parts. I) A biomechanical test was carried out at 45° (n=3) and 65° (n=3) cup inclination angles with 1, 2, 3 and 4 (mm) medial-lateral translational mismatch between the centres of the head and cup. The amount of dynamic separation displacement between the head and cup was measured using a position sensor. The severity of edge loading was determined from the area under the axial force and medial-lateral force outputs during the time of separation [4]. II) A wear test was carried out at 45° (n=6) and 65° (n=6) cup inclination angles for three million cycles with translational mismatch of 4mm between the head and cup. The lubricant used was diluted new-born calf serum (25% v/v). Volumetric wear measurements were undertaken at one million cycle intervals and mean wear rates were calculated with 95% confidence limits. Statistical analysis was carried out using ANOVA and a t-test with significance levels taken at p<0.05.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 92 - 92
1 May 2016
Lancaster-Jones O Al-Hajjar M Williams S Jennings L Thompson J Isaac G Fisher J
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Introduction and Aims

In order to improve the longevity and design of an implant, a wide range of pre-clinical testing conditions should be considered including variations in surgical delivery, and patients' anatomy and biomechanics. The aim of this research study was to determine the effect of the acetabular cup inclination angle with different levels of joint centre mismatch on the magnitude of dynamic microseparation, occurrence and severity of edge loading and the resultant wear rates in a hip joint simulator.

Methods

The six-station Leeds Mark II Anatomical Physiological Hip Joint Simulator and 36mm diameter ceramic-on-ceramic bearings (BIOLOX® delta) were used in this study. A standard gait cycle, with a twin-peak loading (2.5kN peak load and approximately 70N swing phase load), extension/flexion 15°/+30° and internal/external ±10° rotations, was applied. Translational mismatch in the medial-lateral axis between the centres of rotation of the head and the cup were considered. In this study, mismatches of 2, 3 and 4 (mm) were applied. Two acetabular cup inclination angles were investigated; equivalent to 45° and 65° in-vivo. These resulted in a total of six conditions [Figure 1] with n=6 for each condition. Three million cycles were completed under each condition. The lubricant used was 25% (v/v) new-born calf serum supplemented with 0.03% (w/v) sodium azide to retard bacterial growth. The wear of the ceramic bearings were determined using a microbalance (XP205, Mettler Toledo, UK) and a coordinate measuring machine (Legex 322, Mitutoyo, UK). The stripe wear was analysed using RedLux software. The dynamic microseparation displacement was measured using a linear variable differential transformer. Mean wear rates and 95% confidence limits were determined and statistical analysis (one way ANOVA) completed with significance taken at p<0.05. Results Increasing the medial-lateral joint centre mismatch from 2 to 3 to 4mm resulted in an increased dynamic microseparation [Figure 2]. A similar trend was observed for the wear. A higher level of medial-lateral mismatch increased the wear rate under both 45° and 65° cup inclination angle conditions [Figure 3]. The mean wear rates obtained under 65° were significantly higher compared to those obtained under the 45° cup inclination angle conditions for a given medial-lateral mismatch in the joint centre (p=0.02 for 2mm mismatch, p=0.02 for 3 mm mismatch, and p<0.01 for 4mm mismatch).


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 77 - 77
1 Jan 2016
Al-Hajjar M Williams S Jennings L Thompson J Isaac G Ingham E Fisher J
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Introduction

Increased wear rates [1, 2] and acetabular rim fracture [3] of hip replacement bearings reported clinically have been associated with edge loading, which could occur due to rotational and/or translational mal-positioning [4]. Surgical mal-positioning can lead to dynamic microseparation mechanisms resulting in edge loading conditions. In vitro microseparation conditions have replicated stripe wear and the bi-modal wear debris distribution observed clinically [5, 6]. The aim of this study was to investigate the effect of steep cup inclination, representing rotational mal-positioning, on the magnitude of dynamic microseparation, severity of edge loading, and the resulting wear rate of a ceramic-on-ceramic bearing, under surgical translational mal-positioning conditions.

Materials and Methods

Ceramic-on-ceramic bearings where the ceramic liner was inserted into a titanium alloy cup (BIOLOX® delta and Pinnacle® respectively, DePuy Synthes, UK) were tested on the six-station Leeds II hip simulator. The first test was run with the cups inclined at an angle equivalent, clinically, to 45° (n=6) and the second test was run with the cups inclined at an angle equivalent, clinically, to 65° (n=6). A standard gait cycle was run. A fixed surgical translational mal-positioning of 4mm between the centres of rotations of the head and the cup in the medial/lateral axis was applied on all stations. Both tests ran for three million cycles each. The lubricant used was 25% new-born calf serum. Wear was assessed gravimetrically using a microbalance (XP205, Mettler Toledo, UK) and geometrically using a coordinate measuring machine (CMM, Legex 322, Mitutoyo, UK). Statistical analysis was done using one way ANOVA with significance taken at p<0.05.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_11 | Pages 144 - 144
1 Jul 2014
Al-Hajjar M Fisher J Hardaker C Kurring G Isaac G Williams S
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Summary Statement

The frictional torque of ceramic-on-ceramic bearings tended to increase with increasing the bearings size (32, 48, 56mm). However, the frictional torque was significantly lower than that measured on metal-on-metal bearings under well positioned and well lubricated conditions.

Introduction

Larger head size in total hip replacement theoretically provides increased range of motion and enhanced stability. However, there are potential clinical concerns regarding increased frictional torques with large diameter metal-on-metal bearings causing loosening of the acetabular cups and corrosion at the taper. The aim of this study was to determine the frictional torques of large diameter BIOLOX® delta ceramic-on-ceramic bearings.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 200 - 200
1 Sep 2012
Williams S Isaac G Fisher J
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INTRODUCTION

Ceramic-on-metal hip replacements (COM, where the head is a Biolox Delta ceramic and liner is Co Cr alloy), have demonstrated reduced wear under standard conditions in vitro compared to metal-on-metal (MOM) [1]. Early clinical results are also encouraging [2]. Recently concerns have been raised regarding the poor clinical performance of MOM hip resurfacings [3], particularly when cups are steeply inclined. Laboratory hip simulator testing has been used to replicate edge loading, also demonstrating elevated wear [4]. Therefore, a range of conditions to replicate sub-optimal use clinically to better predict in vivo performance should be used. The aim of this study was to compare the wear rates of MOM and COM under adverse edge loading conditions in an in vitro hip simulator test.

METHODS

Ceramic-on-metal (n=3) and metal-on-metal (n=3) 36mm hip prostheses (supplied by DePuy International Ltd, UK) were tested in the Leeds Physiological Anatomical Hip Joint Simulator. Liners were mounted to provide a clinical angle of 45o, and stems positioned anatomically. A simplified gait cycle and microseparation was applied as previously described [5] for two million cycles in 25% new born calf serum. Gravimetric analysis was completed every million cycles and wear volumes calculated.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 22 - 22
1 Sep 2012
Brockett C John G Williams S Isaac G Fisher J
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Introduction

Concerns regarding UHMWPE wear particle induced osteolysis in total hip replacement (THR, [1]) have led to alternative materials to be sought. Carbon-fibre reinforced poly-ether-ether-ketone (CFR-PEEK) has shown reduced wear in hip and knee configurations compared with conventional polyethylene [2-4]. The aim of this study was to investigate the wear performance of a ceramic-on-CFR PEEK THR through a simulator study.

Methodology

Five 36mm diameter Biolox Delta heads were paired with extruded CFR-PEEK cups and tested in a hip wear simulator (Simulator Solutions, UK) for 10 million cycles (Mc). Tests were performed in a Prosim hip simulator, which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of −15 to +30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted anatomically. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide. Wear was assessed gravimetrically at several intervals adjusted for moisture uptake using loaded and unloaded soak controls.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 107 - 107
1 Sep 2012
Hadley M Hadfield F Hardaker C Isaac G Fisher J Wye J Barnett J
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Introduction

Hip wear simulation is a widely used technique for the pre-clinical evaluation of new bearing designs. However, wear rates seen in vitro can often be significantly different to those seen clinically. This can be attributed to the difference between the optimal conditions in a simulator and wide ranging conditions in real patients.

This study aimed to develop more clinically relevant simulator tests, looking specifically at the effects of cup inclination angle (in vivo) and stop-dwell-start (SDS) protocols on a clinically available product.

Method

Five tests using a Paul type walking cycle (ISO 14242) were carried out on two ProSim hip simulators:

28mm MoM, standard walking, cup inclination 45°, (n = 5)

36mm MoM, standard walking, cup 45°, (n = 4)

36mm MOM, SDS: 10 walking cycles and pause of 5s with stance load of 1250N cup 45°, (n = 5)

36mm MOM, SDS: 10 walking cycles and pause of 30s with stance load of 1250N, (n = 5) cup 45°

36mm MOM, standard walking, cup 55°(n = 5), and 65°(n = 5).

All samples had matched clearances, measured using a CMM (Prismo Navigator, Zeiss, Germany). Wear was measured gravimetrically (Sartorius ME235S: 0.01mg).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 8 - 8
1 Mar 2012
Cobb A Isaac G McLennan-Smith R Oakeshott R Siebel T
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Introduction

A metal ion study was undertaken in patients who had received an articular surface replacement. The design of these components is optimised in line with lubrication theory and produces low levels of wear in hip joint simulators.

Methods

Patients were recruited in four centres. Whole blood samples were analysed for metal ion levels using high resolution ICP-MS (inductively coupled plasma mass spectrophotometry). A total of 75 patients was enrolled into the study and 65 and 47 patients were assessed after 12 and 24 months implantation respectively. Results are included irrespective of clinical outcome.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_IV | Pages 29 - 29
1 Mar 2012
van der Jagt D Williams S Brekon A Schepers A Isaac G Fisher J
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The search for the ideal bearing surface in Total Hip Replacements continues. The current ‘best’ materials are felt to be combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best bearing surface combination with the lowest adverse side effect profile.

Between February 2004 and September 2007, 164 hips were replaced in 142 patients. 39% were male and 69% were female. The average age at surgery was 53 years (17-72 years). Follow-up assessment included radiographs, the Harris Hip Score and whole blood samples for metal ion levels. Complications to date included 3 hips which needed femoral revision because of surgery related factors, and 3 cases of sepsis of which 1 settled and 2 needed revision. One hip needed revision of head and liner to a larger bearing size for recurrent dislocations, and is no longer being followed up for blood metal ions.

Post-operative whole blood metal ion levels were compared to pre-operative levels to determine the increase or decrease in metal ion levels. There were no changes in those patients with ceramic-on-ceramic and ceramic-on-polyethylene articulations. Moderately raised whole blood metal ion levels were noted at 3 months in the ceramic-on-metal group, while the metal-on-metal group show the greatest increase.

This study agrees with laboratory bearing surface wear studies demonstrating lower wear rates in the ceramic-on-metal group compared to the metal-on-metal group. With concerns related to high blood metal ion levels in metal-on-metal articulations, ceramic-on-metal bearing surfaces may well become a bearing surface of choice in the future, but progress needs to be monitored in the longer term.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_II | Pages 172 - 173
1 May 2011
Isaac G Toumasis S Siebel T
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The long-term performance of surface replacement devices remains unknown. One area of concern is the viability of the bone in the proximal portion of the femur. Previous studies, using a single time point, have shown reduced loss in bone stock compared to total hip replacement and minimal difference with the contra-lateral, unaffected hip. The aim of this study is use DEXA scanning to report the changes in bone mineral density (BMD) which take place at different time points up to 5 years post-op in the same patients following implantation. The effect of component placement will also be considered

Thirty patients were recruited (24 male, 6 female; 16 left hip 14 right, mean age at surgery 53 years, range 28–65). DEXA measurements were taken post- operatively and at 3, 12, 24 and 60 months. During the study 2 patients were revised and 8 were lost to follow-up. Thus the number of patients available at each follow-up were 28, 29, 23 and 20 respectively. The regions of interest were R1 (neck region), R2 (Gruen zones 2,6) and R3 (Gruen zones 3,5).

BMD in zones R1, R2 and R3 post-operatively were significantly different, 0.955, 1.114 and 1.457g/cm2 respectively (p< 0.0001). In the R1, BMD reduced at 3m to 95.0% (p=0.005) and then recovered to higher than the post-op level 102.2% (p=0.241) by 12m, and further increases to 103.5% (p=0.019) at 24m and 103.9% (p=0.057) at 60m.

In zone R2, BMD reduced at 3m (97.4%, p=0.02) but recovered to post-op levels after 12m and is maintained thereafter. In zone R3 there were no significant differences from post-op. In zone R1 at 3m, 20/28 cases (71%) had a BMD that was less than the immediate post-operative value. At 12m only 12/29 cases (41%) had reduced BMD, the balance (59%) undergoing an increase. The comparable values at 60m follow-up were 43% and 57%. There was a trend for patients with higher post-op BMD to undergo a greater reduction at 3m whilst showing a greater level of recovery after 60m. However patients with higher post-op BMD had the highest 3m and 60m values. There was a trend for older patients to have a lower post-op BMD although this was not translated into greater reductions in BMD. There was no obvious correlation between femoral component angle and BMD. However there was a trend for components with a higher cup angle to undergo a greater reduction in BMD at both 3m and 60m. The current cohort was dominated by male patients and therefore comparison by gender was not possible.

Changes in BMD were confined to the neck region (R1) and Gruen zones 2, 6 (R2). The finding that BMD reduces in R1 at 3m but by 12m has recovered to postop levels in R2 and in R1 has exceeded post-op levels, strongly suggests that whatever inter-operative trauma takes places is quickly repaired and changes beyond 12m are minimal out to 60m.


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 35 - 35
1 Jan 2011
Williams S Brockett C Hardaker C Isaac G Fisher J
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Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings. This has been attributed to reduced corrosive and adhesive wear, and differential hardness. The study assessed the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation.

Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and CoCrMo alloy. Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. Testing was conducted in calf-serum for 2-million cycles. A standard simulator cycle was adapted, the head sub-luxed in the swing-phase forcing the head onto the cup rim at heel strike.

The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM.

The COM concept allows thin metal shells to be used with larger ceramic heads and protects against ceramic liner chipping. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 511 - 511
1 Oct 2010
Brockett C Breckon A Fisher J Isaac G Schepers A Williams S
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Ceramic-on-metal (COM) bearings have shown reduced wear and friction compared with metal-on-metal (MOM) bearings in-vitro. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces, improved lubrication and differential hardness reducing adhesive wear. Clinical studies have also shown reduced metal ion levels in-vivo compared with MOM bearings. The aim of this study was to examine two explanted COM bearings (one head and cup, one head only), and to assess the effect of in-vivo changes on the wear performance of the COM bearings by comparing the wear of the explanted bearings with three new COM implants in a hip wear simulator.

Two 28mm diameter COM bearings were provided for analysis. These were visually examined and surface profilometry was performed using a 2-D contacting profilometer (Form Talysurf, Taylor Hobson, UK). Scanning electron microscopy was used to image the regions of transfer on the ceramic heads, and EDX to assess the transfer composition (Philips XL30 ESEM).

Hip simulator testing was conducted for 2 million cycles (Mc) comparing the explanted bearings with three new 28mm COM bearings. Tests were performed in a Prosim simulator (SimSol, UK), which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of − 15 to 30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted in the anatomical position. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide and was changed approximately every 0.33Mc. Wear was measured gravimetrically at 0.5, 1 and 2 Mc.

Regions of material transfer, identified on both ceramic explant heads, were shown to be CoCr material by EDX analysis, suggesting metallic transfer from the metal cup. Profilometry traces across metallic transfer showed comparable surface roughness measurements compared to unworn material.

The overall mean wear rate for the new COM bearings at 2Mc was 0.047 ± 0.06mm3/Mc. The mean wear rate for the explanted head articulated with a new cup was slightly lower at 0.034mm3/Mc. The mean wear rate for the explanted head and cup was highest at 0.15mm3/Mc. It was noted that the explanted head/cup had higher bedding in wear compared with the other bearings, but still significantly less than a new MOM bearing (mean bedding-in wear rate 2.03 ± 2.59 mm3/Mc). The steady-state wear was comparable with the new bearings. As the orientation of these implants in-vivo was unknown, it is proposed that the elevated wear during bedding-in of the explanted head/cup bearing may be due to the alignment of the components. The wear rates of the explanted ceramic head against a new cup were comparable with the new bearings, suggesting that the presence of metallic transfer on the ceramic head does not adversely affect the wear behaviour of COM bearings.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 519 - 520
1 Oct 2010
Isaac G Siebel T
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Surface replacement is widely used as a treatment for younger patients requiring hip replacement. However the long-term performance of such devices remains unknown. One area of concern is the viability of the bone in the proximal portion of the femur. These concerns are related to the trauma which the proximal femur is exposed to during the operative procedure and the level of vascularity which is subsequently attained. Previous studies have used a single time point and shown reduced loss in bone stock compared to total hip replacement and minimal difference with the contra-lateral unaffected hip. The aim of this study is to report the changes in bone mineral density (BMD) which take place at different time points in the same patients following implantation using DEXA scanning. The effect of component placement and metal ion levels will also be considered

A total of twenty-six patients were recruited (18 male, 5 female; 15 left hip 11 right, mean age at surgery 56 years, range 31–69) who had DEXA measurements at all three time points post-op, 120 and 420 days (4 and 14 months). Measurements were taken in the neck region and Gruen zones 6 and 7. Metal ion levels were measured in whole blood using the high resolution ICP-MS technique.

The BMD in the neck region, zone 7 and 6 post-operatively were 0.945, 1.092 and 1.451g/cm2 respectively. In the neck region BMD reduces at 120 days (96.5%) and then increases to higher than the post-op level at 420 days (103.6%, differences between all three groups: p< 0.008).

In zone 7, BMD drops at 120 days (98.2%, p=0.03) but recovers to higher than post-op levels after 420 days (101.65%)but not significantly so (p=0.13). In zone 6 there are no significant differences at any ime points.

Despite the wide variation in the immediate postoperative bone density (0.70–1.25g/cm2), there is no obvious relationship between this value and the capacity of the bone to recover from the operative trauma

Twenty-three of these patients were also part of a metal ion study previously reported. There was no relationship between the combined metal ion levels (chromium+cobalt) at 12 months and the changes in BMD in the neck region at 4 or 14 months.

There was no significant difference in the response of the male and female patients. There was no significant relationship between changes in BMD and cup abduction angles, femoral component inclination nor acetabular component diameter.

This is a short-term study, however it is reassuring that whilst BMD reduces in the neck and Gruen zone 7, by 420 days (14 months) it has recovered to postop levels and in zone 7 has exceeded the post-op levels. Furthermore this response appears to be unrelated to patient factors and component position.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 520 - 520
1 Oct 2010
Isaac G Breckon A Brockett C Fisher J Schepers A Van Der Jagt D Williams S
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The combination of a ceramic head articulating against a metal acetabular liner (CoM) has shown reduced metal ion levels compared with a metal-on-metal bearing (MoM) in hip simulator studies. A randomized prospective clinical trial was undertaken using CoM and MoM bearings in an otherwise identical total hip procedure. The initial clinical results were encouraging. This report comprises a further review of metal ion data.

Patients received identical components with the exception of the bearing surface material but all were 28mm diameter. All components were supplied by DePuy International Ltd. Patients were assessed pre-operatively, 3m, 12m and > 24m (median 32m). Whole blood samples were collected at regular follow-ups, frozen and analysed in batches using high resolution Inductively Coupled Plasma – Mass Spectrometry (ICP-MS). All recruited patients are included irrespective of outcome. However some patients failed to attend specific follow-ups and some contaminated samples had to be discarded. Statistical significance was analyzed using a non-parametric comparison (Mann-Whitney test). After 3m and 12m implantation there were between 21 and 24 patients available for analysis in both the CoM and MoM cohort and after > 24m point 10 and 9 respectively.

There were four outliers (either Cr or Co > 10ug/l) in both the CoM and MoM groups. In common with previous studies (with the exception of two marginal outliers), these were related to component position. They were implanted with either a cup abduction angle of > 55°, an anteversion angle of > 30° or both. Other studies with the same design of component have reported no significant outliers.

The median Cr and the Co levels are lower with the CoM bearing compared with the MoM at all measurements points following implantation. The median background (pre-operative) levels for the combined CoM and MoM group were Cr: 0.22ug/l and Co: 0.49ug/l. These were significantly different (p=0.006).

In the CoM group, the median 12m Cr and Co values were 0.43ug/l and 0.72ug/l respectively. The comparable values for MoM are 0.68ug/l and 0.83ug/l. Increases in metal ion levels from pre-operative levels are used as the primary ion level outcome in this study because the background level will comprise of the order of 30–50% of the overall value. The increase in Cr for CoM and MoM from pre-op levels to 12m significantly different for Cr (p=0.015). It has a lower significance for combined metal ion levels (p=0.029). This difference in not significant for Co (p=0.195).

In agreement with predictions from hip simulator studies, CoM bearings in this study produced lower levels of metal ions than comparable MoM bearings at all time points. However the difference is less than that predicted in the laboratory and is much more pronounced with Cr than with Co.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 313 - 313
1 May 2010
Williams S Brockett C Hardaker C Isaac G Fisher J
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Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings (Firkins et al., 1999). This has been attributed to a reduction in corrosive wear, differential hardness and a reduction in adhesive wear. In a clinical report on the use of a metal-on-ceramic hip replacement (Valenti et al., 2007) which consisted of a stainless steel head and alumina ceramic insert at revision 6-months post-op massive metallosis and macroscopic wear was observed.

The aim of this study was to assess the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation.

Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and high carbon (0.2wt%) CoCrMo alloy (DePuy International Ltd, UK). Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. The lubricant (25% calf-serum) was changed every 0.33Mc, wear was measured gravimetrically. Testing was conducted for 2-million cycles, a standard simulator cycle was adapted so the head subluxed in the swing phase forcing the head onto the cup rim at heel strike (Williams et al., 2006).

The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM.

The explant described Valenti et al. included a stainless steel head, this is a softer material compared to CoCr, and wears at a higher level. It can be postulated that the wear under adverse conditions would be further increased.

The COM concept can provide increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials, early data suggests reduced metal ion release in patients with COM bearings compared to metal-on-metal (Williams et al., 2007).


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 100 - 100
1 Mar 2010
Udofia I Jin Z Williams S Isaac G Fisher J
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Metal-on-metal hip resurfacing has been introduced recently, due to its potential advantages of biomechanics and biotribology. However, a number of problems have been identified from clinical retrievals, including significant elevation of wear when the implant is mal-positioned. Our hypothesis is that implant mal-position and micro-lateralisation can result in edge contact, leading to increases in wear. The aim of this study was to investigate the combined effect of cup position and micro-lateralisation on the contact mechanics of metal-on-metal hip resurfacing prosthesis, in particularly to identify conditions which resulted in edge contact.

Finite element (FE) method was used. A generic metal-on-metal hip resurfacing prosthesis was modelled. The bearing diameters of the femoral head and acetabular cup components were 54.49mm and 54.6mm respectively, with a diametral clearance between the head and the cup of 0.11mm. The resurfacing components were implanted into a hemi-pelvic hip joint bone model and all the materials in the FE model were assumed to be homogenous, isotropic and linear elastic (Udofia et al 2007). The FE models consisted of approximately 80,000 elements, which were meshed in I-DEAS (Version 11, EDS, USA) and solved using ABAQUS (Version 6.7-1, Dassault Systèmes). For this study, the femoral component was fixed with an inclination angle of 45° and an anteversion angle of 10°. The orientation of the acetabular cup was varied, using inclination angles of 35° and 65°, and anteversion angles between −10° to 30°. Contact at the bearing surface between the cup and femoral head was modelled using frictionless surface-based elements, simulating a fully lubricated situation, as coefficients of friction less than 0.1 would not have appreciable effects on the predicted contact mechanics. The femoral component was fixed into the femur (except the guide pin) using PMMA cement with an average thickness of approximately 1mm. The other contact interfaces in the FE model (cup/acetabulum, cement/bone and cement/femoral component) were all assumed to be rigidly bonded. The hip joint model was loaded through a fixed resultant hip joint contact force of 3200N, and was applied through medial, anterior muscle forces and subtrochanteric forces to simulate the mid-to-terminal stance phase (approximately 30% – 50%) of the gait cycle (Bergmann et al., 1993). Micro-lateralisation was modelled through displacing the femoral head laterally, up to 0.5mm, relative the centre of the cup.

Edge contact was detected once the inclination angle became greater than 65°. The effect of ante-version was to further shift the contact area towards the edge of the cup, nevertheless no edge contact was found for ante-version angles up to 25° and inclination angles below 55°. However, when the micro-lateralisation was introduced, edge contact was detected at a much smaller inclination angle. For example, even with a micro-lateralisation of 0.5 mm, edge contact occurred at an inclination angle of 45°. This study highlights the importance of surgical techniques on the contact mechanics and tribology of metal-on-metal hip resurfacing and potential outcome of these devices.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 187 - 187
1 Mar 2010
Williams S Brockett C Isaac G Hardaker C Fisher J
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Ceramic head and metal liner hip replacements (COM) have shown reduced wear in comparison to metal-on-metal (MOM) bearings. The aim of this study was to further assess the performance by a wear simulator study under standard and adverse conditions, including the wear of a metal head against a ceramic liner.

Components were Biolox Delta and CoCrMo alloy. Hip simulator testing applied a simplified walking cycle to anatomically mounted prostheses. The lubricant was 25% calf-serum and wear was measured gravimetrically. In hip simulator testing with edge loading a standard cycle was adapted so the head sub-luxed in the swing phase forcing the head onto the edge of the cup at heel strike, this was applied to ceramic on metal and metal on ceramic material combinations.

Under standard conditions the total overall mean wear rate of the MOM THR (1.01±0.38mm3/Mc) was significantly higher in comparison to the COM and COC (< 0.015mm3/Mc). The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM.

Reduced wear from COM bearings will address some concerns associated with MOM THRs regarding reports of elevated ion levels clinically. These studies have provided valuable data demonstrating reduced wear with COM bearings. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 226 - 226
1 Mar 2010
Schepers A van der Jagt D Isaac G Williams S Fisher J
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A randomised prospective study of four bearing surfaces in hip replacements is being conducted. The primary objective is to identify the best long term bearing surf ace clinically and radiographically, and metal ion levels have been measured in all cases.

Patients have been randomised to the four bearing surfaces viz. Ceramic-on-XLinked Polyethelene, Ceramic-on-Ceramic, Metal-on-Metal and Ceramic-on-Metal. Pre-operative blood samples and follow-up blood samples for metal ion analysis using ICP-MS method have been taken in all patients. As at February 2008 187 patients have been recruited, and metal ion levels at one year are available in 52 patients.

Metal ion levels are not increased with Ceramic-on-XLPE or Ceramic-on-Ceramic bearings. At one year follow-up the metal ion levels in Ceramic-on–Metal bearings is half that of Metal-on-Metal bearings using mean levels, and one third using median levels. Of note is that chromium levels in Ceramic-on-Metal bearings is the least elevated.

Due to the laboratory evidence that ceramic-on-metal bearings have the best surf ace wear characteristics with no head stripe wear on a ceramic head, and the laboratory and clinic al evidence of lower metal ion levels, Ceramic-on-Metal hip replacements could be one of the bearing surfaces of the future.


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 187 - 187
1 Mar 2010
Schepers A Jagt DV Breckon A Williams S Fisher J Isaac G
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A randomised prospective study of 4 bearing surfaces in hip replacements is being conducted. The primary objective is to identify the best long term bearing surface clinically and radiographically, and metal ion levels have been measured in all cases.

Patieents have been randomised to the 4 bearing surfaces viz. Ceramic on XLinked Poly, Ceramic on Ceramic, Metal on Metal and Ceramic on Metal. Pre operative blood samples and follow up blood samples for metal ion analysis using the ICPMS method have been taken in all patients. As at February 2008 187 patients have been recruited, and metal ion levels at 1 year are available in 52 patients.

Metal ion levels are not increased with Ceramic on XLinked Poly or Ceramic on Ceramic bearings. At 1 year follow up the metal ion levels in Ceramic on Metal bearings is half that of Metal on Metal bearings using the mean levels, and one third using the madian levels. Of note is that the chromium levels in Ceramic on Metal bearings is the least elevated.

Due to laboratory evidence that Ceramic on Metal bearings have the best surface wear characteristics with no head stripe wear, and laboratory and clinical evidence of lower metal ion blood levels, Ceramic on Metal hip replacements could be a bearing surface of the future.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 290 - 290
1 May 2009
Brockett C Williams S Isaac G Fisher J
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Ceramic on metal bearings for hip replacement have shown reduced friction, wear, and metal ion levels in comparison to metal on metal bearings. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces and improved lubrication and differential hardness and reduction in adhesive wear. The aim of this study was to further assess the performance of novel differential hardness COM THRs in two different bearing configurations. The effect of bearing configuration was examined by comparing COM (ceramic head on metal liner) with metal-on-ceramic (metal head on ceramic liner) (MOC) bearings in micro-separation hip simulator testing.

Components used were zirconia-platelet toughened alumina (Biolox Delta) heads and high carbon (0.2wt%) CoCrMo alloy cups, tested in COM and MOC configurations, (, (DePuy International Ltd, UK). Micro-separation hip simulator testing was conducted for 2 million cycles (Mc) using a Prosim hip simulator (SimSol, UK), which applied a twin peak loading cycle and walking motions with the prosthesis positioned in the anatomical position. The lubricant (25% calf serum) was changed approximately every 0.33Mc and wear was measured gravimetrically. A negative force was applied to the head during the swing phase, to produce a joint laxity and head – rim contact, the head relocated in the stance phase.

The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/ Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. Stripes of metallic transfer were visible on all the ceramic heads (COM bearings). The COM bearings had much lower wear rates than the MOC bearings under harsh micro-separation conditions. This suggests that the head in a differential hardness bearing should be the harder material. The COM concept also provides increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_II | Pages 289 - 290
1 May 2009
Brockett C Williams S Isaac G Jin Z Fisher J
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Large diameter metal-on-metal (MOM) bearings are becoming increasingly popular for young, active patients. Clearance is a particularly important consideration for designing MOM implants, considering historical experience of equatorial contact and high frictional torque. Lubrication theory predicts increasing the clearance will result in diminished lubrication, resulting in increased friction and wear. Clinical cases of transient squeaking in patients with resurfacing bearings have been noted in recent years, with some reporting an incidence of up to 10% between 6 months and 2 years post-implantation. This study aimed to investigate the impact of increasing clearance on the lubrication, friction and squeaking of a large diameter metal-on-metal resurfacing bearing through frictional studies.

Clinical-grade MOM implants of 55mm diameter and 100μm diametric clearance, and custom-made, 55mm bearings with diametric clearances of approximately 50μm and 200μm (DePuy International Ltd) were tested in a friction simulator. Components were inverted with a flexion-extension of ±25o applied to the head and lubricated with 25% and 100% newborn bovine serum. A peak load of 2kN, with swing-phase loads of 25N, 100N and 300N were applied.

Sound data was recorded during each friction test using a MP3 recorder and pre-amplifier. A microphone was set up at a distance of 50mm from the implant, and data recorded over a minimum of 10 seconds where sound was generated. Sound data was assessed through narrow band analysis on Frequency Master software (Cirrus Research, UK).

Lubrication was assessed by directly measuring the separation between the head and cup during the test cycle by ultrasonic methods (Tribosonics, UK). An ultrasound sensor was bonded to the back of the cup and reflection measurements were taken during the friction tests with a sampling rate of 100Hz. Using equations which related reflection coefficient to lubricant properties and thickness, values for the film thickness were calculated.

The surface replacement with the largest clearance yielded the highest friction factor for each test condition. The difference between the large clearance bearing and the smaller clearance samples was statistically significant in 25% bovine serum, the more clinically relevant lubricant (ANOVA, p< 0.05). The 50μm clearance group yielded similar results to the 100μm clearance bearing, although a slight increase in friction was observed.

Squeaking occurred during every test in the large clearance group. There was a reduced incidence of squeaking in the smaller clearances, with the lowest incidence observed in the 100μm clearance group.

The smallest separation of the head and cup was observed within the large clearance bearings. The best lubrication condition measured ultrasonically was observed within the 100μm clearance bearing. There appeared to be good correlation between friction, lubrication and the incidence of squeaking. This study suggests a large diametric clearance results in reduced lubrication, increased friction and an increased incidence of squeaking. However, there is a minimum diametric clearance that can be tolerated, as clearance must accommodate the manufacturing tolerance.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 89 - 89
1 Mar 2009
Isaac G Fleming J Kay P Nordsletten L Stone M
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Hip arthroplasty has its true genesis in 1962 when the Charnley Total Hip was first implanted. The system comprised a stainless steel femoral stem with fixed 22,225mm head articulating against an all polyethylene acetabular cup. Both components were fixed in position with acrylic bone cement. There have been a number of changes in design, materials and surgical technique but the essential concept remains the same. The system was widely used by both senior and junior surgeons. Numerically implantations peaked at ~45,000 per annum in the late1980’s and is still at around ~25,000 per annum in the mid 2000’s. Geographically the system was used in all five continents. Patients varied widely both in age, activity, and diagnosis. It would therefore seem an appropriate vehicle to examine the variations in results of total hip replacement by patient profile, geography, and era of implantation.

A search was carried out on the US NCBI website for publications reporting on results with the Charnley system up to the end of 2002, and which comprised a follow-up of more than 10 years, and gave survivorship data. This resulted in 28 papers with 14 countries of origin available for review. For all studies basic data such as age and diagnosis, range implantation dates, likely specific design of prosthesis, origin of study and number in study was either reported or could be deduced. A ten year survivorship was reported in 16 studies for stem and cup and 7 for stem only. If the longest follow-up was considered for each study then 18 reported on stem and cup (9392 hips, implanted 1962–92) and 15 on stem only (4243 hips, implanted 1966–91). A total of 11 studies had four of more points on a survivorship curve, seven with stem and cup, four with stem only.

There are a number of points of interest in this data. The first is that with one exception the performance is remarkably consistent as shown by the survivorship curves. There is no significant difference in the survival rates from different centres, countries, and with implantation dates ranging from 1962 through to 1992. Secondly, there appears to have been little or no change in the average age of patients with implant date. There is some evidence to indicate from the 10 year data that failure rate per year is lower in older patients but does not seem to be affected by implantation date. The latter despite the fact that both surgical technique and component design changed over the 30 year implantation period. A further observation is that the failure rate per year is lower in studies with greater numbers of patients.

The general conclusion from this review is that the Charnley Total Hip is remarkably consistent in its performance both over time and location of implantation. Its performance also seems to have been affected very little by changes in technique or design.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_III | Pages 416 - 416
1 Oct 2006
Isaac G Hardaker C Flett M Dowson D
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Purpose of study There is renewed scientific interest in the use of metal-metal bearings for hip replacements. Such bearings have lower volumetric wear rates compared to metal or ceramic on polyethylene bearings. They permit the use of large diameter bearings which potentially have the benefit of reduced dislocation. They also allow the use of thin components without the risk of fracture associated with similar ceramic-ceramic components. However, there remain concerns about the long-term effects of nanometre sized debris and the release of metal ions. It is therefore critical to understand which parameters are important in minimising the amount of debris generated. This study investigated the effect of design and materials on the wear rates in a hip simulator.

Methods Wear studies were carried out in a 10 station ProSim hip simulator in 25% newborn calf serum. A Paul type load curve was applied (maximum load 3000N, minimum 300N) in an anatomical configuration. The extent of a fluid film between the bearing surfaces was determind by measuring the voltage drop between the components. Test samples were made from low-carbon (< 0.05%) and high-carbon (> 0.20%) CoCrMo alloys in various conditions. These samples had bearing surface diameters of 16–54.5mm. The diametral clearance between the femoral head and acetabular cups were from 50–300um.

Results The results of this study were that the low-carbon material wears more than high-carbon materials, there is no significant difference in wear performance of the various forms of high-carbon material tested (wrought, cast, and cast and heat treated), and wear decreased with reduced clearances and increased component diameter. Voltage changes indicated that reduced clearances resulted in component separation and fluid film lubrication

Conclusions These results are consistent with the hypothesis that large diameter metal-on-metal bearings with optimized bearing surface geometry operate in the mixed and/or fluid film lubrication regime.


The Journal of Bone & Joint Surgery British Volume
Vol. 73-B, Issue 5 | Pages 806 - 810
1 Sep 1991
Weightman B Swanson S Isaac G Wroblewski B

Laboratory wear testing of ultra high molecular weight polyethylene from 12 Charnley acetabular cups, removed after periods of up to 17.5 years showed that the large patient-to-patient variations in clinical penetration rate cannot be explained by batch-to-batch variation in the wear resistance of the material. Nor was there any evidence of a time-dependent degradation in wear resistance of the material.


The Journal of Bone & Joint Surgery British Volume
Vol. 72-B, Issue 1 | Pages 149 - 150
1 Jan 1990
Isaac G Wroblewski B Atkinson Dowson D


The Journal of Bone & Joint Surgery British Volume
Vol. 71-B, Issue 1 | Pages 143 - 144
1 Jan 1989
Isaac G Hodgkinson J Wroblewski B


The Journal of Bone & Joint Surgery British Volume
Vol. 69-B, Issue 1 | Pages 61 - 63
1 Jan 1987
Wroblewski B Lynch M Atkinson Dowson D Isaac G

We examined 59 cemented high density polyethylene sockets removed at revision hip arthroplasty. Of these 19 showed areas of wear between the outside of the socket and the acetabular bone. This was associated with lack of acrylic cement in those areas and was also related to the depth of the wear on the articulating surface of the socket. It is suggested that, in some cases, changes at the bone-cement junction are secondary to socket loosening and abrasion against the bone of the acetabulum, rather than to particles migrating from the metal-polyethylene interface. It is therefore important that impingement of the neck of the femoral stem on the edge of the cup be avoided and that, when the socket is inserted, it is not in direct contact with the bone.