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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 46 - 46
1 Apr 2017
Floyd H Lord J Davies E Addison O Grover L
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Background

Investigations into the response to implant debris tend to concentrate on how a population of cells proliferate in the presence of implant material, and how the regulation of cytokines change. For the problem of cobalt-chromium (CoCr) implants this has been done for osteoblasts and osteoclasts to understand how bone resorption, leading to aseptic loosening, is occurring. However, investigating the formation of the extracellular-matrix (ECM) may give a better indication of the mechanisms occurring. ECM is excreted from cells and is important for adhesion, structure, signaling and growth. Type I collagen is the most abundant protein in the ECM and is known to direct tissue development and is therefore a key part of understanding the mechanism behind aseptic loosening.

Methods

3T3-fibroblasts were seeded in Dulbecco's Modified Eagle Medium (DMEM) and supplemented with 100mM ascorbic acid. Every 48hours cells were fed with DMEM and doped with Co and Cr ions until fixation. Sirius Red dye was used to bind to the type I collagen, then removed using NaOH and analysed using UV absorption to show relative amounts of collagen. Type I collagen gel was formed in the presence of Co and Cr ions with and without DMEM and the fibers were imaged using AFM.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 7 - 7
1 Jun 2016
Sidaginamale R O'Hare J Natu S Joyce T Lord J Nargol A Langton D
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Background

Some reports have suggested that debris generated from the head neck taper junction is more destructive than equivalent doses from metal bearing surfaces.

Methods

Part 1. We examined the relationship between the source (taper/bearing) and volume of metal debris on Cr and Co concentrations in corresponding blood and hip synovial fluid samples and the observed agglomerated particle sizes in excised tissues using regression analysis of prospectively collected data at a single revision unit. Part 2. We investigated variables most strongly associated with macroscopic soft tissue injury as documented at revision surgery using ordinal logistic regression. Independent variables included source and volume of CoCr exposure, Cr and Co joint fluid concentrations, joint fluid grade, ALVAL (Aseptic Lymphocytic Vasculitis Associated Lesion) grade, presence of vascular hyalinisation, agglomerated particle size, implant type, patient sex and age.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 4 - 4
1 Jun 2016
O'Hare J Langton D Nargol A Joyce T Brewster N Cooke N Jafri A Lord J Duffy P Holland J
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Introduction

Historical studies have reported incidences of taper corrosion in retrieved MoP hips of 20–50%. These studies relied on visual assessments, rather than using modern analytical techniques.

Patients/Materials and Methods

The Northern Retrieval Registry was initiated to routinely analyse all retrieved hips. The volumetric wear rates of retrieved Exeter head tapers were measured using a coordinate measuring machine using validated methods and compared to the available results obtained from an ongoing study of failed MoM prostheses. Power analysis suggested that we would need at least fifty Exeter head tapers to provide significant results. Non-parametric tests were used to assess differences. We have previously identified head diameter/offset/taper angle and taper surface roughness as variables associated with taper wear. The effect of bearing material combination remains unquantified. These design variables were entered into a multiple regression model following log normalisation of taper wear.


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 5 - 5
1 Nov 2015
Langton D Killen M Sidaginamale R Bowsher J Savisaar C Nargol A Joyce T Lord J
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Introduction

In this study, we aimed to investigate the effect of the topography of the female taper surface on taper wear.

Patients/Materials & Methods

We measured volumetric material loss at the female taper surface of the first consecutive 36mm MoM hips received at our centre. The MoM hips were from a single manufacturer and possessed matching: head size (36mm); taper geometry (5.65 degree 12 14 tapers); and metallurgy (cobalt chrome female taper mated with a titanium stem). Volume loss was measured with a coordinate measuring machine using validated methods. Surface roughness was measured using a Surftest SJ400. There were 111 head tapers available for analysis. The majority had been revised secondary to ARMD, and a minority for loosening. The mean duration of implantation was 56 months. Volumetric wear values were log normalised in order to construct a multiple regression model to investigate the interaction of head offset, the head taper angle and the Rp value of the female taper surface. Rp is a roughness parameter, which is a measure of the peaks above the plateau of a surface.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_4 | Pages 22 - 22
1 Feb 2014
Patel S Hee S Yang Y Ngunjiri A Brown S Friede T Griffiths F Lord J Sandhu H Thistlethwaite J Tysall C Woolvine M Underwood M
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Background

The available treatments for NSLBP (Non-Specific Low Back Pain) provide, typically, small to moderate average benefits to patients. The aim of this pilot cluster RCT was to test the hypothesis that the use of a patient decision aid together with an informed shared decision making consultation would produce better outcomes in satisfaction with treatment at four month follow-up.

Methods

We developed a DSP (Decision Support Package). We randomised the physiotherapists and trained those in the intervention arm in informed shared decision making and communication. Participants were recruited from a local physiotherapy department and those allocated to an appointment with an intervention therapist were sent a copy of the DSP in the post. Participants then attended their appointment as usual.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 75 - 75
1 Mar 2013
Bone M Langton D Lord J Patil S Partington P Joyce T
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Introduction

There is much current debate concerning wear and corrosion at the taper junctions of large head total hip replacements, particularly metal-on-metal hips. Is such damage a modern concern or has it always occurred in total hip replacement but not previously noted. To investigate this five explanted V40 Exeter femoral stems (Stryker Howmedica) were obtained following revision surgery at a single centre. In all cases, the 24–26 mm femoral heads were still attached.

Hypothesis

In conventional ‘small head’ modular hip prostheses such as the Exeter, negligible wear and corrosion is seen at the taper junction of explanted devices.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 28 - 28
1 Jan 2013
Langton D Sidaginamale R Lord J Joyce T Natu S Nargol A
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Background

Previous studies have suggested that the modular junction of metal on metal (MoM) total hip replacements (THR) is an important source of metallic debris.

Methods

We carried out a prospective study using custom techniques to analyse one of the largest collections of failed contemporary MoM devices in the world. All explants from patients who had suffered adverse reactions to metal debris (ARMD) were included in this study. These explants included: 82 36mm THRs, and 147 resurfacing head THRs and 140 resurfacing arthroplasties from several manufactures. Volumetric wear analysis of the bearing surfaces and taper junctions was carried out using a coordinate measuring machine. The relationships between total metallic loss and metal ion concentrations and the macroscopic and histological tissue appearance of THR patients were compared to those in resurfacing patients. Mann Whitney test for non-parametric data was used to assess significant differences between groups.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 29 - 29
1 Jan 2013
Sidaginamale R Langton D Lord J Joyce T Nargol A
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Background

We have previously described the relationship between wear rates of MOM components and soft tissue necrosis. In this study we investigated the link between wear rates, metal ion concentrations and osteolysis.

Methods

All unilateral patients who underwent revision of hip resurfacings at our centre were included. Retrieved components were analysed using a coordinate measuring machine to determine total volumetric material loss and rates of wear. Given the accuracy of the wear calculations (which we have previously published), wear rates were considered “abnormal” if ≥3mm3/yr. ROC curves were constructed to determine a Co concentration which would be clinically useful to detect abnormal wear. During revision, the presence/absence of osteolysis was documented.


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).


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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 17 - 17
1 Sep 2012
Bone M Lord J Patil S Partington P Joyce T
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Background

Hemiarthroplasty of the hip involves the replacement of the femoral side of the joint with a metal prosthesis, resulting in metal-on-cartilage articulation. The two most common types of hemiarthroplasty used are the Austin Moore and the Thomson, both of which are available in either Titanium (Ti) or cobalt chromium (CoCr). Hemiarthroplasty may be more cost effective in elderly patients who have lower life expectancy and are less active.

Materials and Methods

Three Ti and two CoCr hemiarthroplasty components were obtained following revision surgery. Four had an articulating diameter of 44mm and the other was 46mm diameter. These five hemiarthroplasties were analysed using a Mitutoyo LEGEX322 co-ordinate measuring machine (CMM) (manufacturer's claimed scanning accuracy of 0.8μm). In each case a wear map was generated and the wear volume from the articulating surface was calculated using a bespoke MATLAB program.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 104 - 104
1 Sep 2012
Joyce T Lord J Nargol A Meek D Langton D
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Metal-on-metal hip resurfacing prostheses are a relatively recent intervention for relieving the symptoms of common musculoskeletal diseases such as osteoarthritis. While some short term clinical studies have offered positive results, in a minority of cases there is a recognised issue of femoral fracture, which commonly occurs in the first few months following the operation. This problem has been explained by a surgeon's learning curve and notching of the femur but, to date, studies of explanted early fracture components have been limited.

Tribological analysis was carried out on fourteen retrieved femoral components of which twelve were revised after femoral fracture and two for avascular necrosis (AVN). Eight samples were Durom (Zimmer, Indiana, USA) devices and six were Articular Surface Replacements (ASR, DePuy, Leeds, United Kingdom). One AVN retrieval was a Durom, the other an ASR. The mean time to fracture was 3.4 months. The AVNs were retrieved after 16 months (Durom) and 38 months (ASR).

Volumetric wear rates were determined using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy within 1 micron) and a bespoke computer program. The method was validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was accurate to within 0.5mm3. Surface roughness data was collected using a Zygo NewView500 interferometer (resolution 1nm).

Mean wear rates of 17.74mm3/year were measured from the fracture components. Wear rates for the AVN retrievals were 0.43mm3/year and 3.45mm3/year. Mean roughness values of the fracture retrievals (PV = 0.754, RMS = 0.027) were similar to the AVNs (PV = 0.621, RMS = 0.030), though the AVNs had been in vivo for significantly longer.

Theoretical lubrication calculations were carried out which found that in both AVN retrievals and in seven of the twelve cases of femoral fracture the roughening was sufficient to change the lubrication regime from fluid film to mixed. Three of these surfaces were bordering on the boundary lubrication regime. The results show that even before the femoral fracture, wear rates and roughness values were high and the implants were performing poorly.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXIX | Pages 3 - 3
1 Sep 2012
Langton D Ghandi J Sidaginamale R Mereddy P Joyce T Lord J Natu S Nargol A
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Introduction

We conducted independent wear analysis of retrieved metal on metal (MoM) hip components from around the world. All patients with resurfaced hips who developed adverse reactions to metal debris (ARMD) were found to have increased wear of the bearing surfaces. This was untrue in patients with large diameter (?36mm) MoM total hip replacements. This led us to search for other factors leading to ARMD.

Methods

MoM THR explants retrieved from 78 patients suffering ARMD underwent full volumetric wear analysis of bearing surface and taper-junctions using coordinate measuring machine. Scanning electron microscopy (SEM) used to characterise material composition of specific areas.


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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 92 - 92
1 Aug 2012
Joyce T Langton D Lord J Nargol A
Full Access

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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 77 - 77
1 Aug 2012
Lord J Langton D Nargol A Meek R Joyce T
Full Access

Metal-on-metal hip resurfacing prostheses are a relatively recent intervention for relieving the symptoms of common musculoskeletal diseases such as osteoarthritis. While some short term clinical studies have offered positive results, in a minority of cases there is a recognised issue of femoral fracture, which commonly occurs in the first few months following the operation. This problem has been explained by a surgeon's learning curve and notching of the femur but, to date, studies of explanted early fracture components have been limited.

Tribological analysis was carried out on fourteen retrieved femoral components of which twelve were revised after femoral fracture and two for avascular necrosis (AVN). Eight samples were Durom (Zimmer, Indiana, USA) devices and six were Articular Surface Replacements (ASR, DePuy, Leeds, United Kingdom). One AVN retrieval was a Durom, the other an ASR. The mean time to fracture was 3.4 months. The AVNs were retrieved after 16 months (Durom) and 38 months (ASR).

Volumetric wear rates were determined using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy within 1 micron) and a bespoke computer program. The method was validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was accurate to within 0.5mm3. Surface roughness data was collected using a Zygo NewView500 interferometer (resolution 1nm).

Mean wear rates of 17.74mm3/year were measured from the fracture components. Wear rates for the AVN retrievals were 0.43mm3/year and 3.45mm3/year. Mean roughness values of the fracture retrievals (PV = 0.754nm, RMS = 0.027nm) were similar to the AVNs (PV = 0.621nm, RMS = 0.030nm), though the AVNs had been in vivo for significantly longer.

Theoretical lubrication calculations were carried out which found that in both AVN retrievals and in seven of the twelve cases of femoral fracture the roughening was sufficient to change the lubrication regime from fluid film to mixed. Three of these surfaces were bordering on the boundary lubrication regime. The results show that even before the femoral fracture, wear rates and roughness values were high and the implants were performing poorly.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 33 - 33
1 Aug 2012
Lord J Langton D Nargol A Joyce T
Full Access

Wear debris induced osteolysis is a recognized complication in conventional metal-on-polyethylene hip arthroplasty. One method of achieving wear reduction is through the use of metal-on-metal articulations. One of the latest manifestations of this biomaterial combination is in designs of hip resurfacing which are aimed at younger, more active patients. But, do these metal-on-metal hip resurfacings show low wear when implanted into patients?

Using a Mitutoyo Legex 322 co-ordinate measuring machine (scanning accuracy less than 1 micron) and a bespoke computer program, volumetric wear measurements for retrieved Articular Surface Replacements (ASR, DePuy) metal-on-metal hip resurfacings were undertaken. Measurements were validated against gravimetric calculations for volumetric wear using a sample femoral head that was artificially worn in vitro. At 5mm3, 10mm3, and 15mm3 of material removal, the method was shown to be accurate to within 0.5mm3.

Thirty-two femoral heads and twenty-two acetabular cups were measured. Acetabular cups exhibited mean volumetric wear of 29.00mm3 (range 1.35 - 109.72mm3) and a wear rate of 11.02mm3/year (range 0.30 - 63.59mm3/year). Femoral heads exhibited mean wear of 22.41mm3 (range 0.72 - 134.22mm3) and a wear rate of 8.72mm3/year (range 0.21 - 31.91mm3/year). In the 22 cases where both head and cup from the same prosthesis were available, mean total wear rates of 21.66mm3/year (range 0.51 - 95.50mm3/year) were observed.

Revision was necessitated by one of five effects; early femoral neck fracture (4 heads), avascular necrosis (AVN) (2 heads, 1 cup), infection (1 head, 1 cup), adverse reaction to metal debris (ARMD) (19 heads, 18 cups) or ARMD fracture (6 heads, 2 cups). Mean paired wear rates for the AVN and infection retrievals were 0.51mm3/year and 3.98mm3/year respectively. In vitro tests typically offer wear rates for metal-on-metal devices in the region of 2-4mm3.

Mean paired wear rates for ARMD and ARMD fracture were 17.64mm3/year and 68.5mm3/year respectively, significantly greater than those expected from in vitro tests. In the 4 cases of early fracture, only the heads were revised so a combined wear rate calculation was not possible. The heads exhibited mean wear rate of 8.26mm3/year. These high wear rates are of concern.


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.