Impingement testing of total hip replacements according to ASTM F2582 - Implant wear, resistance to damage and acceptance criteria.

OBJECTIVES: The aim of this study was to determine the resistance to impingement damage of three different artificially aged UHMWPE materials used for total hip joint replacement. The results obtained can be used as a basis for an acceptance criterion for testing according to ASTM F2582-20. METHODS: Three different polyethylene liner materials, standard polyethylene (UHMWPE), moderately crosslinked (XLPE) and vitamin E stabilized crosslinked (XLPE-VE) polyethylene of the same design and manufacturer were tested up to one million impingement cycles according to ASTM F2582-20. The liners were artificially oxygen aged for two and three weeks according to ASTM F2003-02. The wear volumes of the liner, acetabular shells, and hip endoprosthesis stems were determined. Each of the six impingement test groups consisted of three samples. For each test group, a reference group was subjected to the same conditioning and loading conditions but without impingement between the hip stem and the liner. The force needed to disassemble the liner from the acetabular shell (push-out force) was determined according to ASTM F1820-22 for the test and the reference groups. RESULTS: XLPE and XLPE-VE polyethylene groups showed less impingement wear when compared to the standard UHMWPE material. Similarly, the protective function of the liner against direct metal-on-metal contact was greater, resulting in less wear on the acetabular shell and the stem neck. The three weeks aged standard UHMWPE group showed early onset of fatigue delamination wear. The push-out values remained unchanged for all XLPE liners and the 3-week aged XLPE-VE liners. The aged UHMWPE liners showed low push-out strength due to component shrinkage caused by aging in combination with the tapered fixation used for this specific design. SIGNIFICANCE: The largest polyethylene wear volume measured of XLPE and XLPE-VE polyethylene aged for two and three weeks was 15.05 mm³ (SD 0.56 mm³). The corresponding metal wear volume was 1.23 mm³ (SD 0.19 mm³) for the acetabular cup and 1.33 mm³ (SD 0.20 mm³) for the stem neck. Those values can support the definition of an acceptance criteria for impingement testing. The results of the push-out test required by ASTM F2582-20 should be evaluated with respect to geometry changes caused by aging. The protective effect of the polyethylene liner against metal-on-metal contact should be considered in the implant design phase in order to avoid implant failure due to metal debris.

[Objectives and limits of test standards]. / Sinn und Grenzen von Prüfnormen.

BACKGROUND: Test standards are developed worldwide by extremely committed expert groups working mostly in an honorary capacity and have substantially contributed to the currently achieved safety standards in reconstructive orthopedics. Independent of the distribution and quality of a test specification, the specialist knowledge of the user cannot replace a well founded risk analysis and if used unthinkingly can lead to a false estimation of safety. LIMITS: The limits of standardization are reached where new indications or highly innovative products are concerned. In this case the manufacturer must undertake the time and cost-intensive route of a self-developed testing procedure which in the ideal case leads to a further testing standard. CONCLUSION: Test standards make a substantial contribution to implant safety but cannot replace the expert knowledge of the user. Tests as an end to themselves take the actual objectives of standardization to absurdity.

Biotribology of a new bearing material combination in a rotating hinge knee articulation.

The objective of the present study was to evaluate the biotribological behaviour, in terms of wear and particle release, of bushings and flanges made of carbon fibre reinforced poly-ether-ether-ketone (CFR-PEEK) in articulation with a zirconium nitride (ZrN) multilayer surface coating in a rotating hinge knee system. For the bushings of the rotational and flexion axles and the medial and lateral flanges, a CFR-PEEK with 30% polyacrylonitrile fibre content was used in a new bearing combination with ZrN. In vitro wear simulation was performed for patients with metal ion hypersensitivity, using a new rotating hinge knee design with a ZrN surface articulation in comparison with the clinically established cobalt-chromium version. For the bushings and flanges made of CFR-PEEK subjected to wear simulation, the volumetric wear rates were 2.3±0.48mm(3)million(-1) cycles in articulation to cobalt-chromium as reference and 0.21±0.02mm(3)million(-1) cycles in the coupling with ZrN, a 10.9-fold decrease. The released CFR-PEEK particles were comparable in size and shape for the coupling to cobalt-chromium and ZrN with most of the particles in a size range between 0.1 and 2µm. The study reveals comparable low wear and no macroscopic surface fatigue in a new rotating hinge knee design with highly congruent flanges and axles bushings made of CFR-PEEK articulating to a ZrN multilayer surface coating. Favourable wear behaviour of the newly introduced CFR-PEEK/ZrN coupling in comparison with the clinically established CFR-PEEK/cobalt-chromium articulation was found.

[Design of a high-dynamic closed-loop controlled cartilage test system]. / Hochdynamisches Prüfsystem zur biomechanischen Charakterisierung von Knorpel und seinen Regeneraten.

Articular cartilage repair methods, in particular scaffold-based autologous chondrocyte implantation, are already in clinical use. In the coming years, the European guidelines on human cell-based medicinal products by the European Medical Agency (EMA) will extend today's quality control mechanisms by additional structural analyses. As articular cartilage has complex biphasic and viscoelastic mechanical properties, a high-performance material test system is required and has already been implemented. To characterize the recovery of cartilage and cartilage replacement materials, it is necessary to measure the dynamic recovery profile. A measurement system for an application like this requires an axis acceleration of more then 50 m/s(2). Furthermore, the test system needs custom-made components to fix the biological specimen while testing. A software package consisting of a graphical user interface and an axis controller leads to highly reproducible tests. The software makes use of a position and velocity controller as well as a force controller at kilohertz speed. While using the high performance force controller it is possible to apply static and dynamic loading profiles that are independent from position or speed set points and signals.

[Which hip articulation bearing for which patient? : Tribology of the future]. / Welche Hüftgelenkgleitpaarung für welchen Patienten? : Tribologie der Zukunft.

Replacement of the hip joint has become an exceptionally successful procedure since the inauguration of the low friction principle by Charnley. Aseptic osteolysis and joint dislocation have been addressed by the development of wear-optimized materials and the introduction of larger heads. As an increase in head diameter against polyethylene causes wear increase, larger hard-on-hard bearings were introduced, which exhibit reduced wear and reduced dislocation risk with increasing head diameter. These findings were derived from standard simulator testing, not sufficiently considering the risk of fluid film breakdown under adverse conditions, which can cause a dramatic increase in wear and friction proportional to the head diameter. Such adverse conditions can occur clinically in patients due to several factors and have caused the presently observed unexpected problems with these new designs. Standardized preclinical testing has to be viewed as a minimum requirement but certainly not as a guarantee for the clinical success of new materials and designs even if the testing is adapted to the current patient requirements, which is presently not the case. The future of tribology lies in the prevention of adverse conditions in patients, the improvement and optimized use of proven existing materials and not in the use of new materials.

Characterization of Wear Particles Generated from CoCrMo Alloy under Sliding Wear Conditions.

Biological effects of wear products (particles and metal ions) generated by metal-on-metal (MoM) hip replacements made of CoCrMo alloy remain a major cause of concern. Periprosthetic osteolysis, potential hypersensitivity response and pseudotumour formation are possible reactions that can lead to early revisions. To accurately analyse the biological response to wear particles from MoM implants, the exact nature of these particles needs to be characterized. Most previous studies used energy-dispersive X-ray spectroscopy (EDS) analysis for characterization. The present study used energy filtered transmission electron microscopy (TEM) and electron diffraction pattern analysis to allow for a more precise determination of the chemical composition and to gain knowledge of the crystalline structure of the wear particles.Particles were retrieved from two different test rigs: a reciprocating sliding wear tribometer (CoCrMo cylinder vs. bar) and a hip simulator according to ISO 14242-1 (CoCrMo head vs. CoCrMo cup). All tests were conducted in bovine serum. Particles were retrieved from the test medium using a previously published enzymatic digestion protocol.Particles isolated from tribometer samples had a size of 100 - 500 nm. Diffraction pattern analysis clearly revealed the lattice structure of strain induced hcp ε-martensite. Hip simulator samples revealed numerous particles of 15 - 30 nm and 30 - 80 nm size. Most of the larger particles appeared to be only partially oxidized and exhibited cobalt locally. The smallest particles were Cr(2)O(3) with no trace of cobalt. It optically appeared that these Cr(2)O(3) particles were flaking off the surface of larger particles that depicted a very high intensity of oxygen, as well as chromium, and only background noise of cobalt. The particle size difference between the two test rigs is likely related to the conditions of the two tribosystems, in particular the difference in the sample geometry and in the type of sliding (reciprocating vs. multidirectional).Results suggest that there may be a critical particle size at which chromium oxidation and cobalt ionization is accelerated. Since earlier studies have shown that wear particles are covered by organic residue which may act as a passive layer inhibiting further oxidation, it would suggest that this organic layer may be removed during the particle isolation process, resulting in a change of the particle chemical composition due to their pyrophoric properties. However, prior to being isolated from the serum lubricant, particles remain within the contact area of head and cup as a third-body. It is therefore possible that during that time, particles may undergo significant transformation and changes in chemical composition in the contact area of the head and cup within the tribological interface due to mechanical interaction with surface asperities.

[Implant wear and aseptic loosening. An overview]. / Verschleiss und aseptische Prothesenlockerung. Eine Bestandsaufnahme.

Wear of total joint implants is multifactorial in nature. Even for identical materials and geometries, the interaction of those parameters can generate different numbers of particles as well as different particle sizes and shapes. These different wear-particle characteristics will directly influence the biological response to an implant and thereby its clinical success. The long-term success of a total joint replacement requires an optimized compromise among implant material, design, surgical procedure, and biological performance.

Fixed and mobile bearing total knee arthroplasty--influence on wear generation, corresponding wear areas, knee kinematics and particle composition.

BACKGROUND: Several studies in literature are dealing with a direct comparison between fixed and mobile bearing knee replacements, but to our knowledge there is no published data comparing the wear behaviour of the two design principles based on the same femur and superior gliding surface geometry. The objective of our study was to investigate a fixed and mobile bearing knee design with identical femoral articulation in regard to wear, tibio-femoral kinematics and particle size distribution. METHODS: In vitro wear simulation according to ISO 14243-1 has been performed with the Columbus knee system (Aesculap, Tuttlingen) in the configurations fixed and mobile bearing for five million cycles on a customized four station knee wear simulator. The tests were running under force control and the tibio-femoral kinematics were assessed. A particle analysis has been undergone after each inspection interval when the lubricant was replaced. FINDINGS: Due to the additional wear in the tibial articulation of the mobile bearing design the mean gravimetric wear rates are not statistically different between the two groups. Apart of that there is a substantial reduction in the amount of wear per area unit for the mobile versus the fixed bearing gliding surfaces. Both groups show comparable tibio-femoral kinematics and a similar wear debris morphology. INTERPRETATION: Our investigation of a fixed and mobile bearing knee design with identical femoral articulation demonstrates that there are no significant differences in wear rate, resulting kinematics and polyethylene particle release. Therefore it can be recommended that surgeons decision for one or the other design principle should be based on the individual patient profile.

Fluid composition impacts standardized testing protocols in ultrahigh molecular weight polyethylene knee wear testing.

Wear of total knee replacements is determined gravimetrically in simulator studies. A mix of bovine serum, distilled water, and additives is intended to replicate the lubrication conditions in vivo. Weight gain due to fluid absorption during testing is corrected using a load soak station. In this study, three sets of ultrahigh molecular weight polyethylene tibial plateau were tested against highly polished titanium condyles. Test 1 was performed in two different institutions on the same simulator according to the standard ISO 14243-1, using two testing lubricants. Test 2 and test 3 repeated both previous test sections. The wear and load soak rates changed significantly with the lubricant. The wear rate decreased from 16.9 to 7.9 mg weight loss per million cycles when switching from fluid A to fluid B. The weight gain of the load soak specimen submersed in fluid A was 6.1 mg after 5 x 10(6) cycles, compared with 31.6 mg for the implant in fluid B after the same time period. Both lubricants were mixed in accordance with ISO 14243 (Implants for surgery - wear of total knee-joint prostheses), suggesting that calf serum should be diluted to 25 +/- 2 per cent with deionized water and a protein mass concentration of not less than 17 g/l. The main differences were the type and amount of additives that chemically stabilize the lubricant throughout the test. The results suggest that wear rates can only be compared if exactly the same testing conditions are applied. An agreement on detailed lubricant specifications is desirable.

Hip simulator wear testing according to the newly introduced standard ISO 14242.

Ultra-high molecular weight polyethylene (UHMWPE) acetabular cups were tested against alumina-ceramic femoral heads using a new type of hip joint simulator according to ISO/FDIS 14242-1. Bovine serum as well as newborn calf serum were used as test fluids. Total polyethylene wear was determined by weight loss of the cups. In addition. wear depth and its distribution were recorded by means of a coordinate measurement system. Wear particle analysis and inspection of the worn polyethylene surfaces using light and scanning electron microscopy (SEM) were performed to analyse damage and identify the acting wear mechanisms. The total wear rate was determined to be 22.07 +/- 1.75 mg/10(6) cycles for the bovine serum group and 26.57 + 3.55 mg/10(6) cycles for the calf serum group. Unexpectedly, the formation of two wear vectors corresponding to recent clinical findings was detected. Retrieved polyethylene wear debris was comparable in size and shape with clinical findings. The test method described by ISO/FDIS 14242-1 produced reliable and reproducible wear data using UHMWPE acetabular cups articulating against alumina-ceramic heads. In the authors' opinion, the lubricant composition should be described in more detail, since the protein and additive content seem to have a high impact on the wear results. It needs to be emphasized that the findings of this study cannot be regarded as a general validation of hip wear tests according to ISO/FDIS 14242-1 but are limited to the material combinations investigated herein. Further testing of other clinically relevant materials and interlaboratory ring tests must follow.

Mechanical simulation of composite hip stems.

Calculation of new orthopedic implants prior to manufacturing of prototypes can be economic in the case of complex production processes. The use of composite materials for highly loaded hip stems is one application of the Finite-Element Method. Due to the anisotropic behaviour of composite structures, special routines had to be programmed for element alignment and failure analysis. Stability of carbon fibre-reinforced epoxy hip stems could be confirmed by experimental results. The risk of neck fracture was found to be one of the critical features in the design process.

[Load bearing capacity of CFK hip prosthesis with ceramic femoral heads]. / Belastbarkeit von CFK-Hüftprothesen mit keramischen Kugelköpfen.

Wear of the articulating surfaces of mating components of total hip endoprostheses is the most important technical factor limiting the functional lifetime of the prosthesis. Biolox ceramic femoral heads have been used successfully throughout the world for more than 20 years. In vitro tests and clinical results show that the artificial modular hip joint system employing a Caproman stem and a ball made of Biolox or Biolox -forte is resistant to mechanical failure. The threshold values for burst load and cyclic load prescribed by the FDA are achieved or bettered. Clinical results support those of the in vitro tests. The femoral head made of Biolox or Biolox -forte used in combination with cups and stems made of Caproman thus complies with the required standards.

[Mechanical stability of hip joint endoprosthesis shafts of carbon fiber composite materials]. / Mechanische Sicherheit von Hüftgelenkendoprothesenschäften aus Kohlenstoffaserverbundwerkstoff.

The use of composite materials in orthopaedic surgery permits the design of implants with varying degrees of stiffness. A system of carbon fibre reinforced epoxy hip stems was investigated and compared to the mechanical safety of metal ones. Special attention has been paid to the fact that torsional moments are the common failure mechanism of composite materials. In total 74 hip stems (three different sizes) have been tested under static and dynamic loading conditions according to ISO 7206. A group of 27 implants was pre-conditioned for 75 days in 80 degrees C Ringer's solution to discover potential degradation effects of absorbed fluids. The carbon fibre hip stems proved to reach run-out loads higher than conventional metal ones. Moisture absorption didn't influence the mechanical properties within the range of the experimental accuracy. The calculated fatigue stress of 750 MPa permits further optimization of stiffness parameters without the risk of implant fracture.