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Bone & Joint Research
Vol. 6, Issue 2 | Pages 113 - 122
1 Feb 2017
Scholes SC Hunt BJ Richardson VM Langton DJ Smith E Joyce TJ

Objectives. The high revision rates of the DePuy Articular Surface Replacement (ASR) and the DePuy ASR XL (the total hip arthroplasty (THA) version) have led to questions over the viability of metal-on-metal (MoM) hip joints. Some designs of MoM hip joint do, however, have reasonable mid-term performance when implanted in appropriate patients. Investigations into the reasons for implant failure are important to offer help with the choice of implants and direction for future implant designs. One way to assess the performance of explanted hip prostheses is to measure the wear (in terms of material loss) on the joint surfaces. Methods. In this study, a coordinate measuring machine (CMM) was used to measure the wear on five failed cementless Biomet Magnum/ReCap/ Taperloc large head MoM THAs, along with one Biomet ReCap resurfacing joint. Surface roughness measurements were also taken. The reason for revision of these implants was pain and/or adverse reaction to metal debris (ARMD) and/or elevated blood metal ion levels. Results. The mean wear rate of the articulating surfaces of the heads and acetabular components of all six joints tested was found to be 6.1 mm. 3. /year (4.1 to 7.6). The mean wear rate of the femoral head tapers of the five THAs was 0.054 mm. 3. /year (0.021 to 0.128) with a mean maximum wear depth of 5.7 µm (4.3 to 8.5). Conclusion. Although the taper wear was relatively low, the wear from the articulating surfaces was sufficient to provide concern and was potentially large enough to have been the cause of failure of these joints. The authors believe that patients implanted with the ReCap system, whether the resurfacing prosthesis or the THA, should be closely monitored. Cite this article: S. C. Scholes, B. J. Hunt, V. M. Richardson, D. J. Langton, E. Smith, T. J. Joyce. Explant analysis of the Biomet Magnum/ReCap metal-on-metal hip joint. Bone Joint Res 2017;6:113–122. DOI: 10.1302/2046-3758.62.BJR-2016-0130.R2


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 549 - 549
1 Nov 2011
Joyce T Langton D Lord J Grigg H Jameson S Cooke N Tulloch C Logishetty R Meek D Nargol A
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Background: There is a paucity of published data with regard to the wear of failed metal on metal (MoM) resurfacing devices.

Materials and Methods: MoM components retrieved from patients from two independent centres experiencing failure secondary to ARMD were analysed using a Mitutoyo Legex 322 coordinate measuring machine (CMM) which has an accuracy of 0.8 microns. Between 4000 – 6000 points were taken on each explant, dependent on the size of the bearing surface. Maximum wear depths and total volumetric wear were calculated. These values were compared to those from control samples retrieved following uncomplicated fractures/femoral collapse secondary to avascular necrosis (after calculating equivalent yearly wear rates).

Results: 58 ARMD components were analysed. This included 22 36mm MoM THRs (DePuy Pinnacle), 28 DePuy ASRs and 8 Zimmer Duroms. There were 30 resurfacing fracture/avascular necrosis controls. Volumetric wear rates and maximum wear depths of ARMD resurfacing components were significantly greater than the resurfacing control group for both the ASR and Duroms (p< 0.05) however 2 ARMD components exhibited similar amounts of wear compared to controls. Wear rates of the ARMD THR group were significantly lower than the ARMD resurfacing group (p< 0.05).

Conclusions: Increased articular wear is associated with an increased incidence of local adverse effects including tissue necrosis, joint effusions and fractures. However, there are a minority of patients who can develop tissue necrosis in the absence of accelerated wear, implying a spectrum of sensitivity This is reflected in the incidence of ARMD in the patient groups at the main study centre: > 5% in the ASR group and approx 1% in the THR group. We believe this indicates a failure of adequate lubrication and the resultant negative effects in larger bearing devices.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_13 | Pages 37 - 37
1 Sep 2014
van der Jagt D Pietzrak J Stein R
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Introduction. Antibiotic loaded polymethyle methacrylate spacers are commonly used in the management of septic hip replacements. Aim. The aim of this study was to determine wear patterns on the articulating surfaces of these spacers, as well as to determine the extent of PMMA particulate debris generation. Method. We took tissue specimens around the acetabulae in 12 cases at the time of the second stage procedure for septic total hip revisions. These were subjected to histological analysis to determine the extent of PMMA particulate debris contamination. We also performed a basic explant retrieval analysis of the articulating surfaces of the PMMA spacers to determine any specific wear patterns. Results. We found numerous PMMA particles in the acetabular soft tissues biopsied. The particle concentration was highest in the area of the acetabular fovea. We could also demonstrate specific wear patterns on the spacers that could be correlated with the generally mismatched articulating couple between the spacer and the bony acetabulum. We could also demonstrate some boney destruction present in the acetabulum with long-term spacer use. Conclusions. We concluded that significant amounts of PMMA particulate debris are generated by these articulating antibiotic spacers. The total volume of this debris may be determined by specific wear patterns on the spacers’ surfaces. We recommend a thorough debridement to decrease the PMMA particle load generated. Consideration in respect of the bearing surface implanted after the explantation of the PMMA spacer should take into account the effect of the debris on the bearing surfaces. We also make recommendations in respect of the design of these PMMA spacers


The Bone & Joint Journal
Vol. 98-B, Issue 7 | Pages 925 - 933
1 Jul 2016
Sidaginamale RP Joyce TJ Bowsher JG Lord JK Avery PJ Natu S Nargol AVF Langton DJ

Aims

We wished to investigate the influence of metal debris exposure on the subsequent immune response and resulting soft-tissue injury following metal-on-metal (MoM) hip arthroplasty. Some reports have suggested that debris generated from the head-neck taper junction is more destructive than equivalent doses from metal bearing surfaces.

Patients and Methods

We investigated the influence of the source and volume of metal debris on chromium (Cr) and cobalt (Co) concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using multiple regression analysis of prospectively collected data. A total of 199 explanted MoM hips (177 patients; 132 hips female) were analysed to determine rates of volumetric wear at the bearing surfaces and taper junctions.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_III | Pages 282 - 282
1 Sep 2005
van der Jagt D Schepers A
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Good short-term results with Mt Blanc uncemented acetabular cups have been previously reported. However, in the medium term, we have observed acetabular loosening related to large granulomatous lytic lesions. To determine the cause of the polyethylene load causing the granulomatous lytic lesions, we subjected six explanted Mt Blanc acetabular cups to retrieval analysis. We also reviewed the literature on polyethylene locking mechanisms in uncemented metal-backed cups and on the deformability of metal-backed cups.

We subjected the retrieved cups to stereo-photographic analysis and to dye penetration and surface scanning electron microscopy techniques. We demonstrated severe polyethylene wear and particle generation on the back surface of the polyethylene insert. This was due both to two-body sliding wear, as characterised by surface deformation and delamination of the polyethylene, and to three-body abrasive wear, as characterised by surface roughness and embedded titanium particles. The literature confirmed that the locking mechanism of the Mt Blanc cup was particularly poor and the deformability greater than in other cups tested. This confirmed the wear patterns on the back-surface of the polyethylene liner.

We caution against the use of uncemented cups that have poor locking mechanisms for the polyethylene liners and those that deform excessively. The combination of poor locking mechanisms and titanium shells is especially dangerous.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_12 | Pages 18 - 18
10 Jun 2024
Haston S Langton D Townshend D Bhalekar R Joyce T
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Despite advancements, revision rates following total ankle replacement (TAR) are high in comparison to other total joint replacements. This explant analysis study aimed to investigate whether there was appreciable metal particulate debris release from various contemporary TARs by describing patterns of material loss. Twenty-eight explanted TARs (9 designs: 3 fixed and 6 mobile bearing), revised for any reason, were studied. The articulating surfaces of the metal tibial and talar components as well as the polyethylene insert were assessed for damage features using light microscopy. Based on the results of the microscopic analysis, scanning electron microscopy with energy dispersive X-ray spectroscopy was performed to determine the composition of embedded debris identified, as well as non-contacting 3D profilometry. Pitting, indicative of material loss, was identified on the articulating surfaces of 54% of tibial components and 96% of talar components. Bearing constraint was not found to be a factor, with similar proportions of fixed and mobile bearing metal components showing pitting. More cobalt-chromium than titanium alloy tibial components exhibited pitting (63% versus 20%). Significantly higher average surface roughness (Sa) values were measured for pitted areas in comparison to unpitted areas of these metal components (p<0.05). Additionally, metallic embedded debris (cobalt-chromium likely due to pitting of the tibial and talar components or titanium likely from loss of their porous coatings) was identified in 18% of polyethylene inserts. The presence of hard 3. rd. body particles was also indicated by macroscopically visible sliding plane scratching, identified on 79% of talar components. This explant analysis study demonstrates that metal debris is released from the articulating surfaces and the coatings of various contemporary TARs, both fixed and mobile bearing. These findings suggest that metal debris release in TARs may be an under-recognised issue that should be considered in the study of painful or failed TAR moving forwards


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 82 - 82
1 Sep 2012
Joyce T Lord J Nargol A Langton D
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Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent innovation. As such, survivorship rates from independent centres alongside explant analysis are rare. The early clinical experience with this novel ceramic-on-metal (CoM) bearing couple is reported alongside explant analysis of failed devices. Methods and materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine (Mitutoyo Legex 322, manufacturer's claimed accuracy 0.8µm). The roughness of the articulating surfaces of heads and liners was measured with a non-contact profilometer (ZYGO NewView 5000, 1nm resolution). Results. In 56 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34–87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm. 3. respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The high early failure rate using a COM articulation is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons and bioengineers need to be aware of this new mechanism of failure in this novel biomaterial coupling which is associated with low metal ions


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 91 - 91
1 Aug 2012
Joyce T Lord J Langton D Nargol A
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Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent introduction. As such, survivorship rates from independent centres alongside explant analysis are rare. The early experience with this novel ceramic-on-metal (CoM) bearing couple is reported. Methods and Materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine. The roughness of the articulating surfaces was measured with a non-contact profilometer. Results. In 54 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34-87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm3 respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The very high early failure rate using COM is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons need to be aware of this new mechanism of failure which is associated with low metal ions


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 47 - 47
1 Apr 2019
Joyce TJ Smith SL Forbes L Rushton PRP Bowey AJ Gibson MJ
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Background. Established hip and knee arthroplasty registers exist in many countries but this is not the case with spinal implants. Moreover, in the case of a rod intended to guide spinal growth in a child and then be removed, the definition of ‘failure’ (revision) used for hip or knee arthroplasty is inappropriate. How can the performance of such spinal implants be judged?. Methods. Ninety-six MAGnetic Expansion Control (MAGEC) spinal rods were obtained from multiple centres after removal from the spines of 52 children with scoliosis. Clinical details were assessed and divided between unplanned revision operations (‘failures’) and those which were planned. Of the explanted rods, 49 were tested for the amount of force they could output, using the manufacturer's supplied test jig. Sixty-five rods were cut apart so that the internal components (bearings, O-ring seals, drive pins) could be assessed, alongside if there was evidence of internal wear. Results. Seventy-four per cent of revision operations were unplanned. Eighty per cent of explanted rods were unable to produce the force expected from a new rod. All rods (100%) that were successfully cut open showed signs of internal wear. Non- functional bearings were seen in 74% of cases, obvious seal damage in 57% of cases and broken drive pins in 47% of cases. Conclusion. Despite potential clinical benefits, explanted MAGEC rods showed consistent and substantial damage. The majority of rods showed zero force output and most revision operations were unplanned. Independent explant analysis allows appraisal of new technology in arthroplasty for patient benefit


The Bone & Joint Journal
Vol. 99-B, Issue 10 | Pages 1304 - 1312
1 Oct 2017
Langton DJ Sidaginamale RP Joyce TJ Meek RD Bowsher JG Deehan D Nargol AVF Holland JP

Aims. We sought to determine whether cobalt-chromium alloy (CoCr) femoral stem tapers (trunnions) wear more than titanium (Ti) alloy stem tapers (trunnions) when used in a large diameter (LD) metal-on-metal (MoM) hip arthroplasty system. Patients and Methods. We performed explant analysis using validated methodology to determine the volumetric material loss at the taper surfaces of explanted LD CoCr MoM hip arthroplasties used with either a Ti alloy (n = 28) or CoCr femoral stem (n = 21). Only 12/14 taper constructs with a rough male taper surface and a nominal included angle close to 5.666° were included. Multiple regression modelling was undertaken using taper angle, taper roughness, bearing diameter (horizontal lever arm) as independent variables. Material loss was mapped using a coordinate measuring machine, profilometry and scanning electron microscopy. Results. After adjustment for other factors, CoCr stem tapers were found to have significantly greater volumetric material loss than the equivalent Ti stem tapers. Conclusion. When taper junction damage is identified during revision of a LD MoM hip, it should be suspected that a male taper composed of a standard CoCr alloy has sustained significant changes to the taper cone geometry which are likely to be more extensive than those affecting a Ti alloy stem. Cite this article: Bone Joint J 2017;99-B:1304–12


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 18 - 18
1 Mar 2017
Stratton-Powell A Tipper J Williams S Redmond A Brockett C
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Introduction. Total ankle replacement (TAR) is less successful than other joint replacements with a 77% survivorship at 10 years. Predominant indications for revision include: Insert dislocation, soft tissue impingement and pain/stiffness. Insert edge-loading may be both a product and cause of these indications and was reported to affect 22% of patients with the, now withdrawn from market, Ankle Evolutive System (AES) TAR (Transysteme, Nimes, France). Compressive forces up to seven times body weight over a relatively small contact area (∼6.0 to 9.2 cm. 2. ), in combination with multi-directional motion potentially causes significant polyethylene wear and deformation in mobile-bearing TAR designs. Direct methods of measuring component volume (e.g. pycnometer) use Archimedes' principle but cannot identify spatial changes in volume or form indicative of wear/deformation. Quantitative methods for surface analysis bridge this limitation and may advance methods for analysing the edge loading phenomena in TAR. Aim. Determine the frequency of edge loading in a cohort of explanted total ankle replacements and compare the quantitative surface characteristics using a novel explant analysis method. Methods. Thirty-two AES TAR devices were implanted and retrieved by the same surgeon (UK Health Research Authority approval: 09/H1307/60). Mean implantation time was 7.8 years (1.5 to 12.1 range). Pain and/or loosening were the primary indications for revision. An Alicona Infinite microscope measured the entire superior surface of each insert (10× mag; 1.76µm lateral resolution). Abbott-Firestone curves were produced per insert to quantify the deviation of the insert surface from flat. Peak material volume (Vmp), core material volume (Vmc), core void volume (Vvc) and dale void volume (Vvv) were measured. Edge loading was identified visually by a depressed area in the insert surface indicative of articulation with the edge of the tibial component. Inserts were identified as either edge-loaded or not edge-loaded and the above analyses compared. Results. Seventeen inserts (53%) showed edge loading. Peak material volume (Vmp) was significantly increased for the edge loaded inserts 5.64 ± 5.42µm compared to the normal inserts 1.29 ± 0.954µm (Independent T-Test, P=0.005). No difference was found for the other volume parameters (Figure 2). A progressive change in insert form, beginning at the edges of the superior insert surface, was evident (Figure 1). Machining marks identified at the centre of several components supported this observation. Discussion. Insert edge loading affected 53% of TAR explants. The volume parameters showed a statistically significant inflection of material at the inserts' edge for the affected ankles. Spatial changes to insert form progressed over time in-vivo. Machining marks at the centre of several inserts remained which indicated the deformation/wear process commenced at the periphery of the insert. Normal ranges of volume change/redistribution are not established for TAR devices and the implications of insert form change are not yet understood. However, edge-loaded components composed over half of this cohort, which reflects the conflict between design simplicity and kinematic complexity. For any figures or tables, please contact authors directly (see Info & Metrics tab above).


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 7 - 7
1 Sep 2012
Gandhi J Sidaginamale R Mereddy P Langton D Joyce T Lord J Natu S Nargol A
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Background. The failure and subsequent withdrawal of the ASR device in both its resurfacing and THR form has been well documented. The National Joint Registry report of 2010 quoted figures of 12–13% failure at five years. Adverse reaction to metal debris (ARMD) is a poorly understood condition and patients developing severe metal reactions may go unrecognised for sometime. Patients and Methods. In 2004 a single surgeons prospective study of the ASR bearing surface was undertaken. We present the ARMD failure rates of the ASR resurfacing and ASR THR systems. The diagnosis of ARMD was made by the senior author and was based on clinical history, examination, ultrasound findings, metal ion analysis of blood and joint fluid, operative findings and histopathological analysis of tissues retrieved at revision. Mean follow up was 52 months (24–81) and 70 patients were beyond 6 years of the procedure at the time of writing. Kaplan Meier survival analysis was carried out firstly with joints designated “failure” if the patient had undergone revision surgery or if the patient had been listed. A second survival analysis was carried out with a failure defined as a serum cobalt > 7µg/L. Full explant analysis was carried out for retrieved prostheses. Results. There were 505 ASR patients in total. 657 metal ion samples were available at the time of writing (152 repeats). Survival analysis using revision/listed as end point (at 6 years):. ASR resurfacing: 26.1% failure. ASR THR: 55.5% failure. Survival using ion analysis (at 5 years):. ASR resurfacing: 50.1% failure. ASR THR: 66.5% failure. The median (range) volumetric wear rate of failed prosthesis was 8.23mm. 3. /year (0.51–95.5). Conclusion. A number of design flaws in the ASR has led to excessive wear of the bearing & taper leading to catastrophic failure secondary to ARMD


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 549 - 549
1 Nov 2011
Langton D Jameson S Van Oursouw M De Smet K Nargol A
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Background: Definitive cup position for the reduction of blood metal ion levels has yet to be established. Methods: Samples for serum metal ion analysis are taken routinely from patients under the care of the two senior authors of this paper. Both are high volume experienced hip resurfacing surgeons, one based in England, the other in Belgium. Metal ion results from two centres from patients with unilateral joints were correlated to size and orientation of femoral and acetabular components, UCLA activity score, age, time post surgery and post operative femoral head/neck ratios. EBRA software was used to assess cup inclination and anteversion on standing radiographs. Cup orientation in vivo was compared to explant analysis of 60 retrieved resurfacing components using a coordinate measuring machine. Results: Three resurfacing devices were studied. There were 620 results in total. Only femoral size and cup inclination/anteversion were found to have any effect on ion levels. In all devices, metal ion levels were inversely related to femoral size (p< 0.05). The device providing the smallest acetabular coverage arc was associated with the highest metal ion levels. Consistent throughout the implants, lowest ion levels were associated with cups with radiological inclination of 40–50° and anteversion 10–20°. Cup inclination angles lower than 40° were associated with posterior edge loading and likely sub-luxation of the femoral component. Conclusion: The greater the coverage angle provided by the acetabular component, the greater the tolerance to suboptimal position. Lowest ion levels were found in well positioned lower clearance devices. Cup inclination/ante-version angles of 45/15+/−5° were associated with low ion levels in all three devices. We do not recommend cups to be placed with inclination angles below 40°


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_I | Pages 38 - 38
1 Jan 2011
Langton D Jameson S Joyce T Webb J Nargol A
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This report documents the clinical and histological findings, the operative management and the explant analyses of patients with early aseptic failure of large metal-on-metal (MonM) bearing joints. Three hundred and fifty patients have been implanted with the ASR bearing surface (resurfacing or a modular THR) by a single surgeon at an independent centre since 2004. Six patients (all female) have been revised secondary to aseptic failure. All complained of severe groin pain exacerbated by straight leg raise and routine investigations were unable to establish a cause. Large amounts of sterile, highly viscous green fluid were aspirated from the hip joints in each case. Gross swelling of the pseudocapsule and a similar green fluid surrounding the implants were found at revision surgery. Histological examination of periprosthetic tissue samples showed changes consistent with ALVAL/metallosis, and analysis of the fluid revealed dense numbers of inflammatory cells. Symptoms in patients revised to ceramic-on-ceramic bearings improved post operatively. This was not the case with those reimplanted with MoM joints. Data from a subset of 76 patients (all unilateral resurfacings) showed that malaligned cups (anteverted > 20° +/− inclination angle > 45°) were associated with significantly higher whole blood metal ion levels than cups positioned within this range. All the patients with early aseptic failure had malaligned cups. Independent explant analysis revealed significant increases in the surface roughness values of the articular surfaces. Our results suggest that some patients develop a significant inflammatory reaction to metal implants. This may be due to high levels of metal debris around the implant as a result of accelerated wear. Poor component alignment was found in all our patients with early aseptic failure


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_III | Pages 298 - 298
1 Jul 2011
Langton D Jameson S Joyce T Ramasetty N Natu S Antoni N
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In our independent centre, from 2002 to 2009, 155 BHRs (mean F/U 60 months) have been implanted as well as 420 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems (mean F/U 35). During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 17 failures of this nature in patients with ASR implants (12 females) and 0 in the BHR group. This amounts to a failure of 3.5% in the ASR group. Tissue specimens from revision surgery showed varying degrees of “ALVAL” as well as consistently high numbers of histiocytes. Particulate metal debris was also a common finding. The mean femoral size and acetabular anteversion and inclination angles of the ARMeD group/all asymptomatic patients was 45/49mm (p< 0.001), 27/20°(p< 0.001) and 53/48°(p< 0.08). Median blood chromium(Cr) and cobalt(Co) was 29 and 69 μg/L respectively in the ARMeD group versus 3.9 and 2.7 μg/L in the asymptomatic patients (n=160 with ion levels). Explant analysis confirmed greater rates of wear than expected. Lymphocyte proliferation studies involving ARMeD patients showed no hyper reactivity to Cr and Co in vitro implying that these adverse clinical developments are mediated by a toxic reaction or a localised immune response. Our overall results suggest that the reduced arc of cover of the fourth generation ASR cup has led to an increased failure rate secondary to the increased generation of metal debris. This failure rate is 7% in ASR devices with femoral components _47mm


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_III | Pages 390 - 391
1 Jul 2010
Langton D Jameson S Joyce T Natu S Logishetty R Tulloch C Nargol A
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In our independent centre, in the period from January 2003 to august 2008, over 1100 36mm MoM THRs have been implanted as well as 155 Birmingham Hip Resurfacing procedures, 402 ASR resurfacings and 75 THRs using ASR XL heads on SROM stems. During this period we have experienced a number of failures with patients complaining of worsening groin pain at varying lengths of time post operatively. Aspiration of the hip joints yielded a large sterile effusion on each occasion. At revision, there were copious amounts of green grey fluid with varying degrees of necrosis. There were 11 failures of this nature in patients with ASR implants (10 females) and 2 in the 36 MoM THR group (one male one female). Tissue specimens from revision surgery showed varying degrees of ‘ALVAL’ as well as consistently high numbers of histiocytes. Metal debris was also a common finding. A fuller examination of our ASR cohort as a whole has shown that smaller components placed with inclinations > 45° and anteversions < 10 or > 20° are associated with increased metal ion levels. The 11 ASR failed joints were all sub optimally positioned (by the above definition), small components. Explant analysis using a coordinate measuring machine and out of roundness device confirmed greater than expected wear of each component. The lower number of failures in the 36mm MoM group, as well as the equal sex incidence, suggests that the majority of these failures are due to the instigation of an immune reaction by large amounts of wear debris rather than adverse reactions to well functioning joints. It is likely that small malpositioned ASRs function in mixed to boundary lubrication, and this, combined with the larger radius of these joints compared to the 36mm MoM joints, results in more rapid wear


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 92 - 92
1 Aug 2012
Joyce T Langton D Lord J Nargol A
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Background. The worldwide withdrawal of the DePuy Articular Surface Replacement (ASR) device in both its resurfacing and total hip replacement (THR) form on 26 August 2010, after 93,000 were implanted worldwide, has had major implications. The 2010 National Joint Registry for England and Wales quoted figures of 12-13% failure at five years; however these figures may be an underestimate. Patients and methods. In 2004 a single surgeon prospective study of the ASR bearing surface was undertaken. Presented are the Adverse Reaction to Metal Debris (ARMD) failure rates of the ASR resurfacing and ASR THR systems. The diagnosis of ARMD was made by the senior author and was based on clinical history, examination, ultrasound findings, metal ion analysis of blood and joint fluid, operative findings and histopathological analysis of tissues retrieved at revision. Acetabular cup position in vivo was determined using EBRA software. Mean follow up was 52 months (24-81) and 70 patients were beyond 6 years of the procedure at the time of writing. Kaplan Meier survival analysis was carried out firstly with joints designated ‘failure’ if the patient had undergone revision surgery or if the patient had been listed for revision. A second survival analysis was carried out with a failure defined as a serum cobalt concentration > 7microgrammes/L (MHRA guideline from MDA-2010-069). Full explant analysis was carried out for retrieved prostheses. Results. There were 505 ASR hips in total (418 resurfacings and 87 THRs). 657 metal ion samples were available at the time of writing including 152 repeats. Survival analysis using revision/listed for revision as end point (at 6 years): ASR resurfacing: 26.1% failure; ASR THR: 55.5% failure. Survival using ion analysis (at 5 years): ASR resurfacing: 50.1% failure; ASR THR: 66.5% failure. The median (range) volumetric wear rate of failed prostheses was 8.23mm3/year (0.51-95.5). Failure and high ion concentrations are linked to acetabular cup size, anteversion and inclination. Increased failure rates in THRs were due to wear at the taper junction of head and stem. Conclusion. Design flaws in the ASR have led to excessive wear and consequently catastrophic failure rates secondary to ARMD


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 57 - 57
1 Mar 2010
Joyce* T Langton D Jameson S Nargol A
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Resurfacing metal-on-metal hip arthroplasty is currently showing promising clinical results. However there are concerns related to such implants, including the elevated levels of metal ions typically seen in patients. Valuable data can be obtained from explanted prostheses but due to their recent introduction few retrieval studies on resurfacing hip prostheses have been published. Five ASR hip resurfacing prostheses were revised due to pain. From two patients, head and cup were available for independent explant analysis. In the other three cases only femoral components were available. All were removed from female patients and all were revised to ceramic-on-ceramic hip prostheses. Post-operative radiographic measurements of cup inclination and ante-version were obtained using the EBRA software. The surface roughness values of the articulating surfaces of the explants were measured using a non-contacting profilometer. A co-ordinate measuring machine was used to measure the diameter of the head and the cup and thus the diametral clearance. The same measurements were then taken from a new unused ASR prosthesis and compared. Using elastohydrodynamic theory the minimum effective film thickness of the implant was calculated. In turn this allowed the lubrication regime to be determined. The average roughness values of the head and the cup of one implant were found to be 0.135microns and 0.058microns respectively, with a diametral clearance of 110microns. These results indicated that, at the time of removal, the prosthesis would have operated in the boundary lubrication regime. Other explants showed evidence of localised contact between the head and the rim of the acetabular cup, and these showed articulating surfaces with typical roughness values of between 0.025microns and 0.050microns. The new ASR had head and cup surface roughness values of 0.010microns and 0.012microns respectively and a diametral clearance of 87microns, implying that a new implant would operate under fluid film lubrication. All cups five were implanted with inclination angles over 45 degrees and anteversion over 25 degrees. These results suggest that components with high inclination and anteversion angles display greater than expected wear and may operate in boundary rather than fluid film lubrication which may eventually lead to early failure


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1791 - 1801
1 Dec 2021
Bhalekar RM Nargol ME Shyam N Nargol AVF Wells SR Collier R Pabbruwe M Joyce TJ Langton DJ

Aims

The aim of this study was to investigate whether wear and backside deformation of polyethylene (PE) tibial inserts may influence the cement cover of tibial trays of explanted total knee arthroplasties (TKAs).

Methods

At our retrieval centre, we measured changes in the wear and deformation of PE inserts using coordinate measuring machines and light microscopy. The amount of cement cover on the backside of tibial trays was quantified as a percentage of the total surface. The study involved data from the explanted fixed-bearing components of four widely used contemporary designs of TKA (Attune, NexGen, Press Fit Condylar (PFC), and Triathlon), revised for any indication, and we compared them with components that used previous generations of PE. Regression modelling was used to identify variables related to the amount of cement cover on the retrieved trays.


Bone & Joint Research
Vol. 8, Issue 3 | Pages 146 - 155
1 Mar 2019
Langton DJ Natu S Harrington CF Bowsher JG Nargol AVF

Objectives

We investigated the reliability of the cobalt-chromium (CoCr) synovial joint fluid ratio (JFR) in identifying the presence of a severe aseptic lymphocyte-dominated vasculitis-associated lesion (ALVAL) response and/or suboptimal taper performance (SOTP) following metal-on-metal (MoM) hip arthroplasty. We then examined the possibility that the CoCr JFR may influence the serum partitioning of Co and Cr.

Methods

For part A, we included all revision surgeries carried out at our unit with the relevant data, including volumetric wear analysis, joint fluid (JF) Co and Cr concentrations, and ALVAL grade (n = 315). Receiver operating characteristic curves were constructed to assess the reliability of the CoCr JFR in identifying severe ALVAL and/or SOTP. For part B, we included only patients with unilateral prostheses who had given matched serum and whole blood samples for Co and Cr analysis (n = 155). Multiple regression was used to examine the influence of JF concentrations on the serum partitioning of Co and Cr in the blood.