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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_13 | Pages 15 - 15
1 Mar 2013
Petheram T Bone M Joyce T Partington P
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Recent NICE guidance recommends use of a well proven cemented femoral stem for hip hemiarthroplasty in management of fractured neck of femur. The Exeter Trauma Stem (ETS) has been designed based on the well proven Exeter hip stem. It has a double taper polished stem design, proclaimed to share geometry and surface finish with the Exeter hip. This study investigated the surface finish of the two stems in order to investigate the hypothesis that they were different. Two ETS and two Exeter stems were examined using a profilometer with a sensitivity of one nanometer. Macroscopic visual inspection showed that the two Exeter stems had significantly smoother surface finish than the ETS stems. The roughness average (RA) values on the ETS stems were approximately an order of magnitude higher than those of the Exeter stems, mean of 0.235μm compared with 0.025μm (p<0.0001). This difference in surface finish has implications for the biomechanical functioning of the stem. Previous change of the Exeter stem to a matt surface-finish in 1976 resulted in a significant increase in stem failure rates and an understanding of the importance of the polished surface-finish in order to function within a taper-slip philosophy. By changing the surface finish in the ETS stem, longevity of the implant may similarly be affected. Clinical results have yet to be published demonstrating this. We recommend the manufacturer reconsiders the surface finish of the ETS stem to ensure it functions as well as the Exeter primary stem with which it shares a design philosophy.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 51 - 51
1 Mar 2013
Smith S Li L Johnson G Joyce T
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Wear of polymeric glenoid components has been identified as a cause of loosening and failure of shoulder implants1,2 in vivo. A small number of shoulder joint simulators have been built for in vitro wear testing, however none have been capable of testing with physiological motion patterns in three axes and with physiological loading. The Newcastle Shoulder Wear Simulator was designed with three axes of motion, which are programmable so that different activities of daily living might be replicated. The simulator uses three pneumatic cylinders with integral position encoders to move five shoulder prostheses simultaneously in the flexion-extension, abduction-adduction, and internal-external rotation axes. Axial loading is applied with pneumatic cylinders supplied from a pneumatic proportional valve via a manifold, which also supplies a sixth static control station. In order to establish if that the machine can actually perform as intended, commissioning trials were conducted replicating lifting a 0.5 Kg weight to head height as a daily living activity. During the commissioning trials JRI Orthopaedics Reverse VAIOS shoulder prostheses were tested in 50% bovine serum at ambient temperature. The results show that the shoulder joint wear simulator can satisfactorily reproduce a daily living activity deliberately selected for having a large range of motion and loading. Other daily activities, such as drinking from a mug, are less demanding in the ranges of motion and loading and represent no difficulty in being reproduced on the simulator. Now successfully commissioned, this new multi-station shoulder wear simulator can wear test current and new designs of shoulder prosthesis in vitro


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 52 - 52
1 Mar 2013
Bone M Giddins G Joyce T
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Introduction

Ten explanted pyrolytic carbon components of a number of finger prostheses were obtained at revision surgery for wear analysis. Implants were removed for either dislocation or failure of fixation. Hypothesis Failure of the components was due to wear from the articulating surfaces, as occurs in many hip and knee prostheses.

Methods

The articulating surfaces were examined using a ZYGO NewView 5000 non-contact profilometer with a resolution of 1nm, to determine the roughness average (RA) of the surface. A total of 86 RA measurements were taken. Detailed images of the surface displayed as a 3D map of were acquired. The RA values for each component were averaged and compared against the British standard for orthopaedic implants, which states that the articulating surfaces of devices made of metal or ceramic should have RA values lower than 0.050 µm.


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
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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.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 59 - 59
1 Aug 2012
Bone M Cunningham J Field J Joyce T
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Finger arthroplasty lacks the success seen with hip and knee joint replacements. The Van Straten Leuwen Poeschmann Metal (LPM) prosthesis was intended for the proximal interphalangeal (PIP) joints. However revision rates of 30% after 19 months were reported alongside massive osteolysis. Three failed LPM titanium niobium (TiNb) coated cobalt chrome (CoCr) components were obtained- two distal and one proximal.

All three components were analysed using an environmental scanning electron microscope (ESEM). This gave the chemical composition of the surface to determine if the TiNb surface coating was still intact. The distal components were analysed using a ZYGO non-contact profilometer (1nm resolution) with the proximal component unable to be analysed due to its shape. ZYGO analysis gave the roughness average (Ra) of the surface and determined the presence of scratches, pitting and other damage.

Images obtained from both the ZYGO and the ESEM indicated that the surfaces of all components were heavily worn. On the articulating surfaces of both distal components unidirectional scratching was dominant, while the non-articulating surface showed multidirectional scratching. The presence of unidirectional scratching suggested two-body wear, whilst the multidirectional scratching on the non-articulating surface of the distal component suggested that trapped debris may have caused three-body wear.

The ESEM chemical analysis showed that in some regions on the distal component the TiNb coating had been removed completely and in other areas it had been scratched or penetrated. On the proximal component the TiNb coating had been almost completely removed from the articulating surfaces and was only present in small amounts on the non-articulating surfaces. There was little evidence of bone attachment to the titanium coating which was intended to help provide fixation.

ESEM images showed the coating had been removed in some sections where there was minimal scratching, suggesting this scratching did not impact significantly in the coating removal. Therefore here the main cause of coating removal may have been corrosion, although scratching may have also have played a part.

The osteolysis reported clinically may have been linked to the wear debris from the failed coating.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVI | Pages 77 - 77
1 Aug 2012
Lord J Langton D Nargol A Meek R Joyce T
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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 = 0.754nm, 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
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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. 94-B, Issue SUPP_XXXVI | Pages 51 - 51
1 Aug 2012
Scholes S Joyce T
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Although bovine serum is the lubricant recommended by several international standards for the wear testing of orthopedic biomaterials there are issues over its use. The inherent batch variation in protein content means that two bovine serum lubricants can give different wear rates. Due to degradation, the lubricant needs to be changed regularly, so that any third body wear particles are removed, thus potentially influencing wear regimes. There are also cost and safety issues with the use of bovine serum. For these reasons, alternative lubricants were investigated.

A 50-station wear test rig was used, which applied multi-directional motion to each ultra-high molecular weight polyethylene (UHMWPE) test pin. Each pin articulated against a cobalt chrome plate polished to better than 0.05 microns Ra. The following lubricants were used: 50% dilute bovine serum; soy protein; olive oil; wheatgerm oil; soya oil; albumin and globulin (AG) mix; albumin, globulin and chondroitin sulphate (AGC) mix; whole milk; Channel Island milk; 11 mg/ml protein egg white; 20 mg/ml egg white; and 40 mg/ml egg white. A minimum of 6 UHMWPE pins per lubricant were wear tested and the tests ran to 2.5 million cycles. Gravimetric measurements were taken throughout the test to determine the volume of wear and at the end of the test the samples were examined using a SEM.

The lubricants giving the closest results to bovine serum were 20 and 40 mg/ml egg white, with mean UHMWPE total wear volumes of 17.4 mm3 and 17.8 mm3 compared to bovine serum which gave 20.7 mm3. Surface topographies showed similar features too. The 11 mg/ml egg white lubricant and the AG and AGC lubricants were next closest in terms of wear. An UV absorbance assay found that all the protein based lubricants suffered from a high degradation rate, and the rate increased with increasing protein content.

Egg white may offer a less expensive alternative to dilute bovine serum as a test lubricant although it is likely that it too would need to be changed as regularly as bovine serum.