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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 31 - 31
17 Nov 2023
Warren J Cowie R Jennings L Wilcox R Fermor H
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Abstract

Objectives

The aim of this study was to develop an in vitro GAG-depleted patella model and assess the biomechanical effects following treatment with a SAP:CS self-assembling hydrogel.

Methods

Porcine patellae (4–6 month old) were harvested and subject to 0.1% (w/v) sodium dodecyl sulfate (SDS) washes to remove GAGs from the cartilage. Patellae were GAG depleted and then treated by injection with SAP (∼ 6 mM) and CS (10 mg) in Ringer's solution through a 30G needle. Native, GAG depleted and SAP:CS treated patellae were tested through static indentation testing, using 15g load, 5mm indenter over 1hr period. The degree of deformation of each group was assessed and compared (Mann-Whitney, p<0.05). Native, GAG depleted, sham (saline only) and SAP:CS treated paired patellae and femurs were additionally characterized tribologically through sequential wear testing when undergoing a walking gait profile (n=6 per group). The cartilage surfaces were assessed and compared (Mann-Whitney, p<0.05) using the ICRS scoring system, surface damage was illustrated through the application of Indian ink.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 59 - 59
17 Apr 2023
Pounds G Liu A Jones A Jennings L
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The aim of this work was to develop a novel, accessible and low-cost method, which is sufficient to measure changes in meniscal position in a whole-knee joint model performing dynamic motion in a knee simulator.

An optical tracking method using motion markers, MATLAB (MATLAB, The MathWorks Inc.) and a miniature camera system (Raspberry Pi, UK) was developed. Method feasibility was assessed on porcine whole joint knee samples (n = 4) dissected and cemented to be used in the simulator (1). Markers were placed on three regions (medial, posterior, anterior) of the medial meniscus with corresponding reference markers on the tibial plateau, so the relative meniscal position could be calculated. The Leeds high kinematics gait profile scaled to the parameters of a pig (1, 2) was driven in displacement control at 0.5 Hz. Videos were recorded at cycle-3 and cycle-50. Conditions tested were the capsule retained (intact), capsule removed and a medial posterior root tear. Mean relative displacement values were taken at time-points relating to the peaks of the axial force and flexion-extension gait inputs, as well as the range between the maximum and minimum values. A one-way ANOVA followed by Tukey post hoc analysis were used to assess differences (p = 0.05).

The method was able to measure relative meniscal displacement for all three meniscal regions. The medial region showed the greatest difference between the conditions. A significant increase (p < 0.05) for the root tear condition was found at 0.28s and 0.90s (axial load peaks) during cycle-3. Mean relative displacement for the root tear condition decreased by 0.29 mm between cycle-3 and cycle-50 at the 0.28s time-point. No statistically significant differences were found when ranges were compared at cycle-3 and cycle-50.

The method was sensitive to measure a substantial difference in medial-lateral relative displacement between an intact and a torn state. Meniscus extrusion was detected for the root tear condition throughout test duration. Further work will progress onto human specimens and apply an intervention condition.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_9 | Pages 58 - 58
17 Apr 2023
McCall B Cowie R Jennings L
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The clinical success of osteochondral autografts is heavily reliant on their mechanical stability, as grafts which protrude above or subside below the native cartilage can have a negative effect on the tribological properties of the joint [1]. Furthermore, high insertion forces have previously been shown to reduce chondrocyte viability [2]. Commercial grafting kits may include a dilation tool to increase the diameter of the recipient site prior to insertion. The aim of this study was to evaluate the influence of dilation on the primary stability of autografts.

Six human cadaveric femurs were studied. For each femur, four 8.5 × 8mm autografts were harvested from the trochlear groove and implanted into the femoral condyles using a Smith & Nephew Osteochondral grafting kit. Two grafts were implanted into dilated recipient sites (n=12) and two were implanted with no dilation (n=12). Insertion force was measured by partially inserting the graft and applying a load at a rate of 1 mm/min, until the graft was flush with the surrounding cartilage. Push-in force was measured by applying the same load, until the graft had subsided 4mm below congruency. Significance was taken as (p<0.05).

Average maximum insertion force of dilated grafts was significantly lower (p<0.001) than their non-dilated equivalent [28.2N & 176.7N respectively]. There was no significant difference between average maximum push-in force between the dilated and non-dilated groups [1062.8N & 1204.2N respectively].

This study demonstrated that significantly less force is required to insert dilated autografts, potentially minimising loss of chondrocyte viability. However, once inserted, the force required to displace the grafts below congruency remained similar, indicating a similar degree of graft stability between both groups.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_6 | Pages 43 - 43
1 Apr 2018
Johnston H Abdelgaied A Fisher J Jennings L
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Variation in soft tissue constraints influence the kinematics and wear of total knee replacements (TKRs). The aim of this study was to experimentally investigate the effect of variation in the soft tissue constraints on the output kinematics of a fixed bearing TKR with different insert geometries. The kinematics have been shown to affect the wear rate of TKRs; increased output displacements may result in an increased wear rate. The soft tissue constraints were simulated experimentally using virtual springs.

A new generation six station electromechanical ProSim knee simulator was used with the ISO 14243–1:2009 standard force control inputs; axial force, flexion-extension (FE), tibial rotation (TR) torque and anterior-posterior (AP) force. This allowed the kinematics to vary due to the test conditions. The ISO standard spring tensions of 44N/mm and 0.36Nm/° and gaps of 2.5mm and 6° were used for the AP and TR springs respectively.

Different combinations of the input profiles were run in order to test the effect of their absence. The spring gaps were varied between 0mm–3mm and 0°–6° and the tensions between 0N/mm–250N/mm and 0Nm/°–1Nm/° for the AP and TR respectively. Three tibial insert designs were tested; high conformity curved (CVD), partially lipped (PLI) and flat.

DePuy PFC Sigma fixed bearing components were tested in 25% bovine serum (in 0.04% sodium azide) lubricant. For each test 100 cycles were recorded on each station and then averaged. The CVD insert was used for all tests, the PLI insert was also used to test the effect of spring tension.

The TR and AP output displacement profiles were affected by the FE position along with the TR torque and AP force respectively. The absence of these inputs changed the shape of the output profiles significantly. The spring gaps affected the peak AP and TR displacements (6.4mm to 3.7mm and 8° to 5.8° for maximum and zero spring gaps respectively). The spring tensions had a higher effect on the peak AP than TR position due to the design of the CVD insert restricting the TR movement (8.3mm to 3.7mm and 8.8° to 7.4° for no springs and maximum tension respectively). The spring gaps and tensions affected the amplitudes of the output profiles not their shape.

The lower conformity inserts had a higher peak TR position (23° for the flat and 8.1° for the CVD insert) which occurred earlier in the cycle. The flat insert resulted in more anterior displacement, potentially due to the high conformity on the anterior side of the CVD and PLI inserts. The spring tension test had an increased effect on the PLI than the CVD insert. The PLI insert resulted in a higher change in displacements due to the spring tensions (10.4mm to 3.5mm and 13.6° to 8.8°).

Soft tissue constraints and insert design had a significant effect on the kinematic outputs. Spring tensions and gaps for experimental testing should be chosen to reflect those of a specific patient group.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_6 | Pages 8 - 8
1 Apr 2018
Cowie R Briscoe A Fisher J Jennings L
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Introduction

PEEK-OPTIMA™ has been considered as an alternative bearing material to cobalt chrome in the femoral component of total knee replacements. To better understand the tribology of UHMWPE-on-PEEK-OPTIMA™ and to find the most appropriate environmental conditions under which to test this novel bearing material combination, a series of tests under different protein lubricant concentrations at rig (∼24°C) and elevated temperature (∼35°C) were carried out in simple geometry wear and friction rigs. Under all conditions, the wear of UHMWPE-on-PEEK-OPTIMA™ was compared to UHMWPE-on-cobalt chrome (CoCr).

Methods

The pins used were GUR1020 UHMWPE (conventional, non-sterile) and the plate material was either polished CoCr (Ra<0.01µm) or PEEK-OPTIMA (Ra∼0.03µm) provided by Invibio Ltd, UK. The wear simulation was carried out in a six station reciprocating rig. The kinematic conditions were consistent for all tests and reflected the average cross shear and contact pressure (3.2MPa) in a total knee replacement. Tests were carried out at either rig running temperature (∼24°C) or at elevated temperature (∼35°C) and in varying protein lubricant concentrations (0, 2, 5, 25 and 90%). Wear of the UHMWPE pins was determined by gravimetric analysis. The pin-on-plate friction rig study was carried out at rig temperature in 0, 2, 5, 25 and 90% serum and reflected the contact pressure used in the wear tests. Measurements were taken using a piezoelectric sensor and the steady state friction derived. At least 3 repeats were taken for each study, statistical analysis carried out using ANOVA with significance taken at p<0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_6 | Pages 7 - 7
1 Apr 2018
Cowie R Briscoe A Fisher J Jennings L
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Introduction

Experimental wear simulation of an all-polymer knee implant has shown an equivalent rate of wear of UHMWPE tibial components against PEEK-OPTIMA™ and cobalt chrome femoral components of a similar initial geometry and surface topography. However, when the patella is resurfaced with an UHMWPE patella button, it is important to also ascertain the wear of the patella. Wear debris from the patella contributes to the total volume of wear debris produced by the implant which should be minimised to reduce the potential for osteolysis and subsequent implant loosening. The aim of this study was to investigate the wear of the patellofemoral joint in an all-polymer knee implant. The wear of UHMWPE patellae articulating against PEEK-OPTIMA™ femoral components was compared to UHMWPE articulating against cobalt chrome femoral components.

Materials and Methods

Six mid-size (size C) PEEK-OPTIMA™ femoral components (Invibio Knee Ltd., UK) and six cobalt chrome femoral components of similar initial surface topography and geometry were coupled with 28mm all-polyethylene GUR1020 patellae (conventional, EO sterile) (Maxx Orthopaedics, USA). The implants were set up in a ProSim 6 station electromechanical knee simulator (Simulation Solutions, UK) which was modified for testing the patellofemoral joint. 3 million cycles (MC) of wear simulation was carried out under kinematics aiming to replicate a gait cycle adapted for an electromechanical simulator from previous work by Maiti et al. The simulator used has six degrees of freedom of which four were controlled; axial force up to 1200N, flexion/extension 22°, superior-inferior (SI) displacement (22mm) and Abduction-adduction (AA) (4°). The SI and AA were displacement controlled and driven through the patella. The medial-lateral displacement and tilt (internal/external rotation) of the patella were passive so the patella button was free to track the trochlear groove. The lubricant used was 25% bovine serum supplemented with 0.03% sodium azide to retard bacterial growth. The wear of patellae was determined gravimetrically with unloaded soak controls used to compensate for the uptake of moisture by the UHMWPE. The mean wear rate ± 95% confidence limits were calculated and statistical analysis was carried out using ANOVA with significance taken at p<0.05.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_6 | Pages 35 - 35
1 Apr 2018
Al-Hajjar M Lancaster-Jones OO Ali M Jennings L Williams S Fisher J
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Introduction and Aims

There are many surgical, implant design and patient factors that should be considered in preclinical testing of hip replacement which are not being considered in current standards. The aim of this study was to develop a preclinical testing method that consider surgical positioning, implant design and patient factors and predict the occurrence and severity of edge loading under the combination of such conditions. Then, assess the safety and reliability of the implant by predicting the wear, deformation and damage of the implant bearings under worst case conditions.

Methods

Ceramic-on-ceramic (CoC, 36mm, BIOLOX® delta, Pinnacle®, DePuy Synthes, UK) and metal-on polyethylene (MoP, 36mm, Marathon®, Pinnacle®, DePuy Synthes, UK) bearings were used for this study on multi-station multi-axis hip joint simulators. Two factors were varied, cup inclination angles (45° and 65°) and translational mismatch between the femoral head and acetabular cup (0, 2, 3 and 4 (mm)). Under each condition for both CoC and MoP bearings, three million cycles of gait cycle testing were completed with wear, deformation and/or damage measurements completed at one million cycle intervals. Other outputs of the study were the level of dynamic separation between the femoral head and acetabular cup during gait, the maximum force at the rim during edge loading when the head was sliding back to the cup confinement. Means and 95% confidence limits were determined and statistical analysis were done using one way ANOVA with significance taken at p<0.05.


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. 99-B, Issue SUPP_3 | Pages 83 - 83
1 Feb 2017
Cowie R Aiken S Cooper J Jennings L
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Introduction

Calcium sulfate bone void fillers (CS-BVF) are increasingly being used for dead space management in infected arthroplasty revision surgery. The use of loose beads of CS-BVF close to the articulating surfaces of an implant means there is potential for them to migrate between the articulating surfaces acting as a third body particle. The aim of this study was to investigate the influence of CS-BVF on the third body wear of total knee replacements.

Methods

The influence of CS-BVF on wear was investigated using the commercially available CS-BVF ‘Stimulan’ (Biocomposites Ltd., UK) and posterior stabilised U2 total knee replacement system implants (United Orthopaedic Corp., Taiwan). The experimental wear simulation was performed using a six station ProSim electropneumatic knee simulator (Simulation Solutions, UK) running the Leeds intermediate kinematics input profile [1]. To investigate the damage that could be caused by the third body particles, 5cc of CS-BVF beads (excess) were placed on the tibial component of the implant, the simulator was run dry for 60 cycles before adding lubricant (25% bovine serum supplemented with 0.03% sodium azide) and running for an additional 115,000 cycles representative of the 6–8 weeks the CS-BVF are present in the body prior to their resorption. The surface topography of the cobalt chrome femorals was analysed using contacting profilometry to ascertain whether the third body particles of CS-BVF had damaged the surfaces. To investigate the influence of CS-BVF on the third body wear of the UHMWPE tibials, 3 million cycles (MC) of wear simulation was subsequently carried out. The wear of the UHMWPE tibials was assessed gravimetrically and the wear of implants tested with CS-BVF was compared to the wear against negative controls (initial Ra∼0.02µm) and positive controls (initial Ra ∼0.4µm) damaged with a diamond stylus. N=6 was completed for each condition, statistical analysis was carried out using ANOVA with significance taken at p<0.05.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 1 - 1
1 Feb 2017
Abdelgaied A Fisher J Jennings L
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Introduction

The input mechanical properties of knee replacement bearing materials, such as elastic modulus and Poisson's ratio, significantly contribute to the accuracy of computational models. They should therefore be determined from independent experimental studies, under similar test conditions to the clinical and experimental conditions, to provide reliability to the models. In most cases, the reported values in the literature for the elastic modulus and Poisson's ratio of the bearing materials have been measured under tensile test conditions, in contrast to the compressive operating conditions of the total knee replacements (TKR). This study experimentally determined the elastic modulus and Poisson's ratio of conventional and moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE) under compressive test conditions. These material parameters will be inputs to future computational models of TKR.

Materials/Methods

To determine the Poisson's ratio of the conventional and moderately cross-linked UHMWPE, contact areas of 12mm diameter cylindrical specimens of 10.2mm length were measured experimentally under a compressive displacement of 1mm, at a strain rate of 12mm/min that was held for 10minutes. A computational model was developed in Abaqus, 6.14–1, to simulate this experimental test assuming different values for the Poisson's ratio of the UHMWPE cylindrical specimens. The curve fitted relationship between the computationally predicted contact area and Poisson's ratio was used to calculate the Poisson's ratio of the UHMWPE specimens, using the experimentally measured contact areas. Using a similar approach, the equivalent elastic modulus of the UHMWPE was calculated using the computationally calculated curve fitted contact area-elastic modulus relationship, from the computational simulation of a ball-on-flat compression test, and the experimentally measured contact area from a ball-on-flat dynamic compression test. This experiment used 10mm thick UHMWPE flat specimens against a 63.5mm rigid ball, under a compressive dynamic sinusoidal loading of 250N average load, and 6000 cycles. The applied test conditions maintained the stress level within the reported range for the TKR.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 2 - 2
1 Feb 2017
Abdelgaied A Fisher J Jennings L
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Introduction

Surface wear of polyethylene is still considered a long-term risk factor for clinical success, particularly as life expectancy and activity levels increase. Computational models have been used extensively for preclinical wear prediction and optimization of total knee replacements (TKR). In most cases, the input wear parameters (wear factors and coefficients) to the computational models have been experimentally measured under average contact stresses to simulate standard activities. These wear studies are not therefore applicable for more adverse conditions that could lead to edge loading and high stress conditions, including higher levels of activities and severe loading conditions. The current study investigated the multidirectional pin-on-plate wear performance of moderately cross-linked ultra-high molecular weight polyethylene (UHMWPE) under high applied nominal contact stress, to be used as inputs to a computational model investigating adverse high stress conditions.

Materials/Methods

Moderately cross-linked UHMWPE (GUR_1020,5Mrad gamma irradiation) pins were tested against cobalt–chrome alloy (CoCr) plates in a multidirectional pin-on-plate wear simulator. The CoCr metallic plates were polished to an average surface roughness of 0.01μm. The pin rotation and the plate reciprocation of ±30º and 28mm were in phase, having a common frequency of 1Hz, and resulted in a multidirectional motion at the pin-plate contact surface in a flat-on-flat configuration. Six different pin diameter and applied load combinations were tested, resulting in applied nominal contact stresses from 4 to 80[MPa](Fig.1). Each set was run for 1million cycles in 25% bovine serum as a lubricant. The volumetric wear was calculated from the weight loss measurements using a density 0.93mg/mm3 for the UHMWPE material. The wear factor and wear coefficient were calculated as (volumetric wear/(load x sliding distance)) and (volumetric wear/(contact area x sliding distance)) respectively[1]. Statistical analysis of the data was performed in ANOVA and significance was taken at p<0.05.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 8 - 8
1 Feb 2017
Al-Hajjar M Vasiljeva K Heiner A Kruger K Baer T Brown T Fisher J Jennings L
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Introduction

Previous studies have shown that third body damage to the femoral head in metal-on-polyethylene hip replacement bearings can lead to accelerated wear of the polyethylene liners. The resulting damage patterns observed on retrieved metal heads are typically scratches and scrapes. The damage created in vitro must represent the third body damage that occurs clinically. A computational model was developed to predict the acceleration of wear of polyethylene articulating against in vitro damaged femoral heads. This involved using a damage registry from retrieval femoral heads to develop standardized templates of femoral head scratches statistically representative of retrieval damage

The aim of this study was to determine the wear rates of polyethylene liners articulating against retrievals and artificially damaged metal heads for the purpose of validating a computational wear prediction model; and to develop and validate an in vitro standardised femoral head damage protocol for pre-clinical testing of hip replacements.

Materials and Methods

Twenty nine, 32mm diameter, metal-on-moderately cross-linked polyethylene bearings (MarathonTM) inserted into Ti-6Al-4V shells (Pinnacle®) were tested in this study. All products were manufactured by DePuy Synthes, Warsaw, Indiana, USA. Following a retrieval study seven different damage patterns were defined, and these were applied to the femoral heads using a four-degree-of-freedom CNC milling machine (Figure 1). The ProSim 10-station pneumatic hip joint simulator (Simulation Solutions, UK) was used for experimental wear simulation using standard gait cycles and testing each experimental group for 3 million cycles. The acetabular cups were inclined at 35° on the simulator (equivalent to 45° in vivo). The wear volumes were determined using a microbalance (Mettler-Toledo XP205, Switzerland) at one million cycle intervals. Statistical analysis used was one way ANOVA followed by a post hoc analysis with significance taken at p<0.05.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 12 - 12
1 Feb 2017
Ali M Al-Hajjar M Jennings L Fisher J
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Introduction

Edge loading of hip replacements may result in plastic deformation, creep and wear at the rim of the cup and potentially fatigue failure. Variations in component positioning can lead to dynamic separation and edge loading [1]. The aim of this study was firstly to investigate the effects of translational and rotational positioning on the dynamic separation and severity of edge loading, and secondly to determine the wear rates of metal-on-polyethylene bearings under the more severe separation and edge loading conditions.

Materials and Methods

A hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter metal-on-polyethylene hip replacements (Marathon™, DePuy Synthes Joint Reconstruction, Leeds, UK). 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 head and cup centres. The severity of edge loading was calculated from the area under the axial force and medial-lateral force outputs during the time of separation when the load was acting on the edge of the cup [2]. II) For two conditions (two million cycles), the head and cup were concentric for cups inclined equivalent clinically to 45° (n=3) and 65° (n=3). For two further conditions (three million cycles), 4mm medial-lateral translational mismatch between centres was applied for cups inclined equivalent clinically to 45° (n=6) and 65° (n=6). Volumetric wear measurements were undertaken at one million cycle intervals. The lubricant was diluted new-born calf serum (25% v/v). Plastic deformation and wear were determined using a coordinate measurement machine. Mean values 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_16 | Pages 41 - 41
1 Oct 2016
Ali M Al-Hajjar M Jennings L Fisher J
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Edge loading due to dynamic separation can occur due to variations in component positioning such as a steep cup inclination angle (rotational) or mismatch between the centres of rotation of the head and the cup (translational). The aim of this study was to determine the effect of variations in rotational and translational positioning of the cup on the magnitude of dynamic separation, wear and deformation of metal-on-polyethylene bearings.

Eighteen 36mm diameter metal-on-polyethylene hip replacements were tested on an electromechanical hip simulator. Standard gait with concentric head and cup centres were applied for cups inclined at 45° (n=3) and 65° (n=3) for two million cycles. A further two tests with translational mismatch of 4mm applied between the head and cup bearing centres for cups inclined at 45° (n=6) and 65° (n=6) were run for three million cycles. Wear was determined using a microbalance and deformation by geometric analysis. Confidence intervals of 95% were calculated for mean values, and t-tests and ANOVA were used for statistical analysis (p<0.05).

Under 4mm mismatch conditions, a steeper cup inclination angle of 65° resulted in larger dynamic separation (2.1±0.5mm) compared with cups inclined at 45° (0.9±0.2mm). This resulted in larger penetration at the rim under 65° (0.28±0.04mm) compared to 45° (0.10±0.09mm) cup inclination conditions (p<0.01). Wear rates under standard concentric conditions were 12.8±3.8 mm3/million cycles and 15.4±5.0 mm3/million cycles for cups inclined at 45° and 65° respectively. Higher wear rates were observed under 4mm of translational mismatch compared with standard concentric conditions at 45° (21.5±5.5 mm3/million cycles, p<0.01) and 65° (23.0±5.7 mm3/million cycles, p<0.01) cup inclination.

Edge loading under dynamic separation conditions due to translational mismatch resulted in increased wear and deformation of the polyethylene liner. Minimising the occurrence and severity of edge loading through optimal component positioning may reduce the clinical failure rates of polyethylene.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_16 | Pages 27 - 27
1 Oct 2016
Ali M Al-Hajjar M Jennings L Fisher J
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Edge loading due to dynamic separation can occur due to variations in component positioning such as a steep cup inclination angle (rotational) or mismatch between the centres of rotation of the head and the cup (translational). The aim of this study was to determine the effect of variations in rotational and translational positioning of the cup on the magnitude of dynamic separation, wear and deformation of metal-on-polyethylene bearings.

Eighteen 36mm diameter metal-on-polyethylene hip replacements were tested on an electromechanical hip simulator. Standard gait with concentric head and cup centres were applied for cups inclined at 45° (n=3) and 65° (n=3) for two million cycles. A further two tests with translational mismatch of 4mm applied between the head and cup bearing centres for cups inclined at 45° (n=6) and 65° (n=6) were run for three million cycles. Wear was determined using a microbalance and deformation by geometric analysis. Confidence intervals of 95% were calculated for mean values, and t-tests and ANOVA were used for statistical analysis (p<0.05).

Under 4mm mismatch conditions, a steeper cup inclination angle of 65° resulted in larger dynamic separation (2.1±0.5mm) compared with cups inclined at 45° (0.9±0.2mm). This resulted in larger penetration at the rim under 65° (0.28±0.04mm) compared to 45° (0.10±0.05mm) cup inclination conditions (p<0.01). Wear rates under standard concentric conditions were 12.8±3.8 mm3/million cycles and 15.4±5.0 mm3/million cycles for cups inclined at 45° and 65° respectively. Higher wear rates were observed under 4mm of translational mismatch compared with standard concentric conditions at 45° (21.5±5.5 mm3/million cycles, p<0.01) and 65° (23.0±5.7 mm3/million cycles, p<0.01) cup inclination.

Edge loading under dynamic separation conditions due to translational mismatch resulted in increased wear and deformation of the polyethylene liner. Minimising the occurrence and severity of edge loading through optimal component positioning may reduce the clinical failure rates of polyethylene.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 94 - 94
1 May 2016
Cowie R Briscoe A Fisher J Jennings L
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Introduction

There is a demand for longer lasting arthroplasty implants driving the investigation of novel material combinations. PEEK has shown promise as an arthroplasty bearing material, with potentially relatively bio inert wear debris [1]. When coupled with an all-polyethylene tibial component this combination shows potential as a metal-free knee. In this study, the suitability of PEEK Optima® as an alternative to cobalt chrome for the femoral component of total knee replacements was assessed using experimental knee wear simulation under two kinematic conditions.

Methods

Three cobalt chrome and three injection moulded PEEK Optima® (Invibio Biomaterial Solutions, UK) femoral components of similar geometry and surface roughness (mean surface roughness (Ra) ∼0.02µm) were coupled with all-polyethylene GUR1020 (conventional, unsterilised) tibial components in a 6 station ProSim knee simulator (Simulation Solutions, UK). 3 million cycles (MC) of wear simulation were carried out under intermediate kinematics (maximum anterior-posterior (AP) displacement 5mm) followed by 3MC under high kinematics (AP 10mm) [2] with 25% serum as the lubricant. The wear of the tibial component was assessed gravimetrically. At each measurement point, the surface roughness of the femoral components was determined using contacting profilometry and throughout testing, the bulk lubricant temperature was monitored close to the articulating surfaces.

Statistical analysis was carried out using ANOVA, with significance at p<0.05.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 4 - 4
1 May 2016
Abdelgaied A Brockett C Hardaker C Fisher J Jennings L
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Introduction

To meet the demands of younger more active patients more robust pre-clinical wear testing methods are required, in order to simulate a wider range of activities. A new electromechanical simulator (Simulation Solutions, UK) with a greater range of motion, a driven abduction/adduction axis and improved input kinematic following has been developed to meet these requirements, as well as requirements of the relevant international standards. This study investigated the wear of a fixed bearing total knee replacement using this new electromechanical knee simulator, comparing with previous data from a pneumatic simulator.

Materials/Methods

The wear of six Sigma CR fixed bearing TKRs (DePuy, UK) with curved moderately cross-linked polyethylene inserts (XLK) was determined in pneumatic and electromechanical Prosim knee simulators (Simulation Solutions, UK). Standard gait displacement controlled kinematics were used, with a maximum anterior-posterior displacement of either 10mm (high) or 5mm (intermediate) [1]. The output profiles from the simulators were obtained and compared to the demand input profiles. The lubricant used was 25% new-born calf serum and wear determined gravimetrically. Statistical analysis was performed using the one-way ANOVA with 95% confidence interval and significance was taken at p<0.05.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 15 - 15
1 May 2016
Ali M Al-Hajjar M Fisher J Jennings L
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Introduction

Translational surgical mismatch in the centres of rotation of the femoral head and acetabular cup in hip joint replacements can lead to dynamic microseparation resulting in edge loading contact [1]. Increased wear in retrieved ceramic-on-ceramic bearings has been associated with edge loading [2]. Hip joint simulators were used to replicate increased wear rate, stripe wear and bimodal wear debris size distribution, as seen clinically [3,4]. Recently developed electromechanical simulators are able to comply with the latest international standards, which include three axes of rotation conditions [5]. Previous simulators had applied two axes of rotation under microseparation conditions [6]. Therefore, the aim of this study was to compare the wear of ceramic-on-ceramic bearings obtained under edge loading due to microseparation conditions during gait using the same electromechanical hip joint simulator with two axes of rotation and three axes of rotation conditions.

Materials and Methods

A six-station electromechanical 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. The wear was determined for two million cycles under standard conditions with two axes of rotation conditions (n=6), two million cycles under microseparation conditions with two axes of rotation conditions (n=6) (Figure 1a), and two million cycles under microseparation conditions with three axes of rotation conditions (n=6) (Figure 1b). The loading profiles [5,7] comprised of 3kN twin peak loads and 300N swing phase load under standard conditions. The swing phase load was reduced to approximately 70N under microseparation conditions. Approximately 0.5mm of dynamic microseparation between the head and the cup was applied in the medial/lateral direction. The components were lubricated with 25% new-born calf serum supplemented with 0.03% sodium azide to minimise bacterial growth. The gravimetric wear rates were compared over two million cycles for each test (XP205, Mettler Toledo, UK). The mean wear rates of the head and cup were calculated with 95% confidence limits and statistical analysis was carried out (t-test) with significance levels taken at p<0.05. A coordinate-measurement machine (Legex 322, Mitutoyo, UK) was used to construct a three-dimensional map of the femoral head surface wear.