Challenges associated with using bovine serum in wear testing orthopaedic biopolymers.

For appropriate in vitro wear testing of prostheses and their biomaterials, the choice of lubricant is critical. Bovine serum is the lubricant recommended by several international standards for wear testing artificial joints and their biomaterials because the wear rate and wear mechanisms closely match clinical results of polyethylene bearings. The main problem with the use of bovine serum as a lubricant is protein degradation and precipitation formation, effects that are recognized as having a direct impact on wear processes. Hence, some researchers have questioned the validity of using bovine serum in simulator testing. This paper reviews the various lubricants used in laboratory wear studies and also the properties of the synovial fluid that the lubricant is trying to replicate. It is clear from the literature survey that the composition of bovine-serum-based lubricants does not match that of synovial fluid. In view of this conclusion, it is suggested that there is a need to develop an alternative lubricant that can replace bovine serum.

Material loss at the femoral head taper: a comparison study of the Exeter metal-on-polyethylene and contemporary metal-on-metal total hip arthroplasty.

AIMS: There are limited published data detailing the volumetric material loss from tapers of conventional metal-on-polyethylene (MoP) total hip arthroplasties (THAs). Our aim was to address this by comparing the taper wear rates measured in an explanted cohort of the widely used Exeter THA with those measured in a group of metal-on-metal (MoM) THAs. PATIENTS AND METHODS: We examined an existing retrieval database to identify all Exeter V40 and Universal MoP THAs. Volumetric wear analysis of the taper surfaces was conducted using previously validated methodology. These values were compared with those obtained from a series of MoM THAs using non-parametric statistical methodology. A number of patient and device variables were accounted for using multiple regression modelling. RESULTS: A total of 95 Exeter MoP and 249 MoM THAs were examined. The median volumetric loss from the MoM cohort was over four times larger than that from the MoP cohort (1.01 mm3 vs 0.23 mm3, p < 0.001), despite a significantly shorter median period in vivo for the MoM group (48 months vs 90 months, p < 0.001). Multiple regression modelling indicated that the dominant variables leading to greater female taper material loss were bearing diameter (p < 0.001), larger female taper angles (p < 0.001), and male titanium stem tapers (p < 0.001). CONCLUSION: Consistent with the long-term clinical success of the device, the volumetric material loss from Exeter femoral head tapers was, in general, small compared with that from larger-diameter MoM head tapers. Cite this article: Bone Joint J 2018;100-B:1310-9.

A comparison study of stem taper material loss at similar and mixed metal head-neck taper junctions.

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.

Comparative in vitro wear testing of PEEK and UHMWPE capped metacarpophalangeal prostheses.

Six metacarpophalangeal prostheses were each wear tested to five million cycles. Each prosthesis consisted of a metacarpal component with an approximately hemispherical shell on a titanium body, articulating against a titanium phalangeal component. Four prostheses had a shell made from ultra-high molecular weight polyethylene (UHMWPE) and two had a shell made from polyether ether ketone (PEEK). The tests were undertaken using a finger wear simulator. Despite pre-soaking and the use of control components, lubricant uptake by the metacarpal components was significant. Gravimetrically, the UHMWPE test components showed a greater weight gain than the UHMWPE control components. Therefore there was no apparent wear of any of the UHMWPE test metacarpal components. The original concentric machining marks of the UHMWPE components could still be seen after five million cycles of testing. For the metacarpal components with PEEK shells, gravimetric wear could be measured. Gravimetrically, all of the titanium phalangeal components showed little or no wear. Light scratches in the direction of sliding appeared on the articulating faces of all metacarpal and phalangeal test components, indicating slight abrasive wear.

The influence of the strength of bone on the deformation of acetabular shells: a laboratory experiment in cadavers.

Concerns have been raised that deformation of acetabular shells may disrupt the assembly process of modular prostheses. In this study we aimed to examine the effect that the strength of bone has on the amount of deformation of the acetabular shell. The hypothesis was that stronger bone would result in greater deformation. A total of 17 acetabular shells were inserted into the acetabula of eight cadavers, and deformation was measured using an optical measuring system. Cores of bone from the femoral head were taken from each cadaver and compressed using a materials testing machine. The highest peak modulus and yield stress for each cadaver were used to represent the strength of the bone and compared with the values for the deformation and the surgeon's subjective assessment of the hardness of the bone. The mean deformation of the shell was 129 µm (3 to 340). No correlation was found between deformation and either the maximum peak modulus (r² = 0.011, t = 0.426, p = 0.676) or the yield stress (r² = 0.024, t = 0.614, p = 0.549) of the bone. Although no correlation was found between the strength of the bone and deformation, the values for the deformation observed could be sufficient to disrupt the assembly process of modular acetabular components.

In vitro wear testing of a contemporary design of reverse shoulder prosthesis.

Reverse shoulder arthroplasty is an increasingly common surgical intervention. However there are concerns and known limitations in relation to such joint replacement, while novel designs of reverse shoulder prostheses continue to appear on the market. Many claim to offer improvements over older designs but such assertions are difficult to validate when there is no consensus as to how such implants should be tested in vitro or even if such testing is necessary. In order to permit appropriate in vitro testing of reverse shoulder prostheses a unique, multi-station test rig was designed which was capable of applying motion in three axes to test prostheses. The shoulder simulator can apply up to 110° of motion in the flexion-extension and abduction-adduction axes and up to 90° in the internal-external rotation axis. Dynamic loading of up to 1500 N can be provided. The simulator is computer controlled so that the motions and loading associated with particular activities of daily living can be applied. A 4.5 million cycle wear test of commercially available reverse shoulder prostheses was undertaken using a 'mug to mouth' activity of daily living. Gravimetric analysis was used to characterise wear. After 4.5 million cycles of 'mug to mouth', the average wear rate of the test components was 14.3mm(3)/million cycles. Polyethylene test components showed a reduction in roughness and the median wear particle diameter was 167 nm. A three axis shoulder simulator has been designed and used to successfully test multiple samples of a commercially available reverse shoulder prosthesis.

A comparison of the wear of cross-linked polyethylene against itself with the wear of ultra-high molecular weight polyethylene against itself.

Wear tests were carried out on reciprocating pin-on-plate machines which had pins loaded at 10 N and 40 N. The materials tested were irradiated cross-linked polyethylene sliding against itself, irradiated ultra-high molecular weight polyethylene sliding against itself and non-irradiated ultra-high molecular weight polyethylene sliding against itself. After 153.5 km of sliding, the non-irradiated ultra-high molecular weight polyethylene plates and pins showed mean wear factors under 10 N loads, or a nominal contact stress of 0.51 MPa, of 84.0 x 10(-6) mm3/N m for the plates and 81.3 x 10(-6) mm3/N m for the pins. Under 40 N loads, or a nominal contact stress of 2.04 MPa, the non-irradiated ultra-high molecular weight polyethylene pins sheared at 22.3 km. At the last measurement point prior to this failure, 19.1 km, wear factors of 158 x 10(-6) mm3/N m for the plates and 85.0 x 10(-6) mm3/N m for the pins had been measured. After 152.8 km. the irradiated ultra-high molecular weight polyethylene plates and pins showed mean wear factors under 10 N loads of 59.8 x 10(-6) mm3/N m for the plates and 31.1 x 10(-6) mm3/N m for the pins. In contrast, after 150.2 km, a mean wear factor of 0.72 x 10(-6) mm3/N m was found for the irradiated cross-linked polyethylene plates compared with 0.053 x 10(-6) mm3/N m for the irradiated cross-linked polyethylene pins.

The wear of cross-linked polyethylene against itself.

Cross-linked polyethylene (XLPE) may have an application as a material for an all-plastic surface replacement finger joint. It is inexpensive, biocompatible and can be injection-moulded into the complex shapes that are found on the ends of the finger bones. Further, the cross-linking of polyethylene has significantly improved its mechanical properties. Therefore, the opportunity exists for an all-XLPE joint, and so the wear characteristics of XLPE sliding against itself have been investigated. Wear tests were carried out on both reciprocating pin-on-plate machines and a finger function simulator. The reciprocating pin-on-plate machines had pins loaded at 10 N and 40 N. All pin-on-plate tests show wear factors from the plates very much greater than those of the pins. After 349 km of sliding, a mean wear factor of 0.46 x 10(-6) mm3/N m was found for the plates compared with 0.021 x 10(-6) mm3/N m for the pins. A fatigue mechanism may be causing this phenomenon of greater plate wear. Tests using the finger function simulator give an average wear rate of 0.22 x 10(-6) mm3/N m after 368 km. This sliding distance is equivalent to 12.5 years of use in vivo. The wear factors found were comparable with those of ultra-high molecular weight polyethylene (UHMWPE) against a metallic counterface and, therefore, as the loads across the finger joint are much less than those across the knee or the hip, it is probable that an all-XLPE finger joint will be viable from a wear point of view.

A multi-directional wear screening device and preliminary results of UHMWPE articulating against stainless steel.

This paper describes the design of a pin on plate rig which has been modified to give multi-directional motion to the test pins, resulting in elliptical and quasi-elliptical wear paths. Such paths are closer to those seen in vivo by a femoral head articulating against an acetabular cup. The description of the rig is augmented by the results of a test of ultra high molecular weight polyethylene pins rubbing against stainless steel plates. with dilute bovine serum at 37 degrees C being used as the lubricant. With standard reciprocating motion, a mean wear factor of 0.085 x 10(-6) mm3/N m was found, but with multi-directional motion, the mean wear factor increased to 1.10 x 10(-6) mm3/N m, which is very similar to in vivo wear factors.

A literature review of "failures" of the Swanson finger prosthesis in the metacarpophalangeal joint.

This paper reviews the use of the Swanson finger prosthesis, concentrating on clinical results from the metacarpophalangeal (MCP) joint and modes of prosthetic "failure". While "failure" is generally associated with fracture, it is recognised that fracture does not always necessitate replacement of the Swanson prosthesis. Fracture tends to occur at the junction of the distal stem and hinge of the prosthesis. Initial improvements in ulnar deviation and range of motion (ROM) tend to be gradually reduced over the duration of implantation, and there is little evidence to suggest any long-term improvement in hand strength. Bone erosion and silicone synovitis have been seen but at a much lesser incidence than in other joints implanted with silicone spacers. An evaluation of retrieved Swanson prostheses, tied in with patient history and hand measurements might provide additional information to improve the design of the Swanson prosthesis itself and of other finger prostheses.

Analysis of failed Van Straten LPM proximal interphalangeal prostheses.

The two-piece Van Straten Leuwen Poeschmann Metal (LPM) prosthesis was intended for the proximal interphalangeal joints. However, revision rates of 29% after 19 months were reported, as well as massive osteolysis. Five failed LPM titanium-niobium coated cobalt chromium components were obtained, three distal and two proximal, and subjected to a forensic retrieval analysis. Components were analyzed using a Talysurf contacting profilometer, ZYGO noncontacting profilometer, and environmental-scanning electron microscope. All components were heavily worn. In some regions the titanium-niobium coating had been scratched and penetrated. Elsewhere this coating had been removed where there was minimal scratching, which may have been due to corrosion between the coating and substrate. The osteolysis reported clinically was likely to be linked to the wear debris from the failed titanium-niobium coating and substrate.

Surface finish of the Exeter Trauma Stem: a cause for concern?

Recent guidance recommends the use of a well-proven cemented femoral stem for hemiarthroplasty in the management of fractures of the femoral neck, and the Exeter Trauma Stem (ETS) has been suggested as an example of such an implant. The design of this stem was based on the well-proven Exeter Total Hip Replacement stem (ETHRS). This study assessed the surface finish of the ETS in comparison with the ETHRS. Two ETSs and two ETHRSs were examined using a profilometer with a precision of 1 nm and compared with an explanted Exeter Matt stem. The mean roughness average (RA) of the ETSs was approximately ten times higher than that of the ETHRSs (0.235 µm (0.095 to 0.452) versus 0.025 µm (0.011 to 0.059); p < 0.001). The historical Exeter Matt stem roughness measured a mean RA of 0.973 µm (0.658 to 1.159). The change of the polished Exeter stem to a matt surface finish in 1976 resulted in a high stem failure rate. We do not yet know whether the surface differences between ETS and ETHRS will be clinically significant. We propose the inclusion of hemiarthroplasty stems in national joint registries.

Analysis of the mechanism of fracture of silicone metacarpophalangeal prostheses.

Eleven fractured Sutter metacarpophalangeal prostheses were obtained from the hands of three patients. All of the implants had fractured at the junction of the distal stem and the hinge. After visual examination, the fracture faces were prepared and viewed using a scanning electron microscope. These images indicated that fracture was initiated by abrasion on the dorsal aspect of the distal stem of the prostheses, close to the hinge. Crack propagation was shown to be due to a fatigue process. Once a crack started, its direction of travel could be followed, using topographical features common to engineering fracture analyses. Propagation was from radial to ulnar and from dorsal to palmar.