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.

Influence of Irradiation Temperature on Oxidative and Network Properties of X-Ray Cross-Linked Vitamin E Stabilized UHMWPE for Hip Arthroplasty.

Previous studies have shown that increased cross-link density, reduced free radicals, and increased antioxidant grafting resulting from electron-beam irradiation at elevated temperatures improved the wear performance and the oxidative stability of vitamin E blended UHMWPE. The current study explores the impact of elevated irradiation temperature on vitamin E blended UHMWPE using X-ray. We hypothesize that the effects of temperature would be similar to those observed after electron-beam irradiation due to the relatively high dose rate of X-rays. Two X-ray doses of 80 and 100 kGy and two irradiation temperatures, that is, room temperature and 100°C were considered. The reference was Vitelene®, a vitamin E stabilized polyethylene cross-linked with 80 kGy by e-beam at 100°C. Oxidation index and oxidation induction time, as well as cross-link density, gel fraction, and trans-vinylene index, were determined, as the oxidative and network properties are decisive for the long-term implant performance. Gel fraction and oxidation induction time were significantly improved subsequently to warm irradiation in comparison with the material irradiated at room temperature. In conclusion, X-ray irradiation at elevated temperatures resulted in an increase of cross-linking and oxidative resistance of vitamin E stabilized polyethylene comparable to those of e-beam irradiated UHMWPE.

Histopathological Analysis of PEEK Wear Particle Effects on the Synovial Tissue of Patients.

Introduction. Increasing interest developed in the use of carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK) as an alternative bearing material in knee arthroplasty. The effects of CFR-PEEK wear in in vitro and animal studies are controversially discussed, as there are no data available concerning human tissue. The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris. The authors hypothesized no difference between the used biomaterials. Methods and Materials. In 10 patients during knee revision surgery of a rotating-hinge-knee-implant-design, synovial tissue samples were achieved (tibial inserts: UHMWPE; bushings and flanges: CFR-PEEK). One additional patient received revision surgery without any PEEK components as a control. The tissue was paraffin-embedded, sliced into 2 µm thick sections, and stained with hematoxylin and eosin in a standard process. A modified panoptical staining was also done. Results. A "wear-type" reaction was seen in the testing and the control group. In all samples, the UHMWPE particles were scattered in the tissue or incorporated in giant cells. CFR-PEEK particles were seen as conglomerates and only could be found next to vessels. CFR-PEEK particles showed no giant-cell reactions. In conclusion, the hypothesis has to be rejected. UHMWPE and PEEK showed a different scatter-behavior in human synovial tissue.

Unilateral laminoplasty with lateral mass screw fixation for less invasive decompression of the cervical spine: a biomechanical investigation.

PURPOSE: To compare the stabilization behavior of additional unilateral mass screw fixation with current standard procedures in patients with cervical spondylotic myelopathy (CSM) in a biomechanical study. METHODS: Ten human C2-C7 cervical specimens were tested under various segment conditions: native (NAT), laminoplasty (LP), laminoplasty with unilateral (LPU) or bilateral (LPB) stabilization, laminectomy with bilateral stabilization (LCB), and laminectomy. The instrumented level was from C3 to C6. For each segment condition, in vitro flexibility tests were performed using a spinal simulator and an applied load of ±2.5 Nm. The three-dimensional kinematics of the entire cervical segment in three main loading directions [flexion-extension (FE), lateral bending (LB), and axial rotation (AR)] was measured with an ultrasonic motion analysis system. Analysis of variance followed by a post hoc test was used to determine differences under the specific segment conditions to assess the parameters range of motion (ROM) and neutral zone (NZ). RESULTS: For FE, the total ROM of laminoplasty (-6.3% difference to NAT) and laminectomy (+6.4%) remained at the level of native (p > 0.56), whereas the instrumentations LPU (-37.1%), LPB (-44%), and LCB (-43.2%) lead to significant reductions (p < 0.01) without significant differences in LPU to LPB and LCB (p > 0.38). The same results were found with LB. For AR, the stabilization of all instrumentations was less pronounced, but had the same tendency seen for FE and AR. The results for the NZ showed equivalent values as that for ROM. CONCLUSION: The degree of stabilization was as expected for LC and LCB; namely, no stabilization for LC and maximal stabilization for LCB. LPU exhibited almost the same degree of stabilization as LCB. LPU could be a new treatment option for less invasive decompression for multilevel CSM.

The effect of design parameters of interspinous implants on kinematics and load bearing: an in vitro study.

INTRODUCTION: A number of concepts with controversy approaches are currently discussed for interspinous stabilization (IPS). However, comparative biomechanical studies among the different systems are rare. Nevertheless, it remains unclear which biomechanical characteristics are influenced by different design features of these implants, such as implant stiffness or an additional tension band. Therefore, the aim of the present study was to compare different interspinous implants to investigate the biomechanical impact of IPS implant design on intersegmental kinematics, such as range of motion, neutral zone, center of rotation (COR), as well as load transfer like intradiscal pressure (IDP), to gain additional experience for clinical indications and limitations. MATERIAL AND METHOD: Twelve human lumbar spine specimens were tested in a spine loading apparatus. In vitro flexibility testing was performed by applying pure bending moments of 7.5 Nm without and with additional preload of 400 N in the three principal motion planes. Four interspinous implants, Coflex "COF" (Paradigm Spine, Germany), Wallis "WAL" (Abbott Laboratories, France), DIAM "DIA" (Sofamor Danek, France) and InterActiv (Aesculap AG, Germany) with two treatment options (without dorsal tensioning "IAO" and with dorsal tensioning "IAM") were consecutively tested in comparison to the native situation "NAT" and to a defect situation "DEF" of the functional spinal unit. The tested IPS devices are comprised of a compression stiffness range of 133 to 1,674 N/mm and a tensile stiffness range of 0-39 N/mm. Range of motion, neutral zone, center of rotation and intradiscal pressure were analyzed for all instrumentation steps and load cases. CONCLUSION: For the IPS, we found a correlation between compression stiffness and stabilization in extension. Here, the system with the lowest stiffness, DIA, displayed nearly no stabilization of the treated segment, whereas the system with the highest stiffness, WAL and COF, was most pronounced. This applies also for the correlation between device stiffness and IDP. In flexion only the degree of stabilization is in correlation with the tensile stiffness, whereas the IDP stays constant and is not affected by the different tensile stiffness. IPS is not able to stabilize in the frontal and transversal plane. Furthermore IPS does not substantially alter the location of the COR.

Elevated cytokine expression of different PEEK wear particles compared to UHMWPE in vivo.

Due to their mechanical properties, there has been growing interest in poly-ether-ether-ketone (PEEK) and its composites as bearing material in total and unicompartmental knee arthroplasty. The aim of this study was to analyze the biological activity of wear particles of two different (pitch and PAN) carbon-fiber-reinforced- (CFR-) PEEK varieties in comparison to ultra-high-molecular-weight-polyethylene (UHMWPE) in vivo. The authors hypothesized no difference between the used biomaterials. Wear particle suspensions of the particulate biomaterials were injected into knee joints of Balb/c mice, which were sacrificed after seven days. The cytokine expression (IL-1ß, IL-6, TNF-α) was analyzed immunohistochemically in the synovial layer, the adjacent bone marrow and the articular cartilage. Especially in the bone marrow of the two CFR-PEEK varieties there were increased cytokine expressions compared to the control and UHMWPE group. Furthermore, in the articular cartilage the CFR-PEEK pitch group showed an enhanced cytokine expression, which could be a negative predictor for the use in unicondylar knee systems. As these data suggest an increased proinflammatory potential of CFR-PEEK and its composites in vivo, the initial hypothesis had to be refuted. Summarizing these results, CFR-PEEK seems not to be an attractive alternative to UHMWPE as a bearing material, especially in unicompartmental knee arthroplasty.

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.

The influence of contact conditions and micromotions on the fretting behavior of modular titanium alloy taper connections.

Modularity of femoral stems and neck components has become a more frequently used tool for an optimized restoration of the hip joint center and improvement of patient biomechanics. The additional taper interface increases the risk of mechanical failure due to fretting and crevice corrosion. Several failures of titanium alloy neck adapters have been documented in case-reports. An experimental fretting device was developed in this study to systematically investigate the effect of micromotion and contact pressure on fretting damage in contact situations similar to taper interfaces of modular hip prostheses under cyclic loading representative of in vivo load conditions. As a first application, the fretting behavior of Ti-6Al-4V titanium alloy components was investigated. Micromotions were varied between 10µm and 50µm, maximum contact pressures between 400 and 860N/mm(2). All modes of fretting damage were observed: Fretting wear was found for high micromotions in combination with low contact pressures. Fretting fatigue occurred with reduced movement or increased contact pressures. With small micromotions or high normal pressures, low fretting damage was observed. The developed device can be used to evaluate taper design (and especially contact geometry) as well as different materials prior to clinical use.

Influence of material coupling and assembly condition on the magnitude of micromotion at the stem-neck interface of a modular hip endoprosthesis.

Hip prostheses with a modular neck exhibit, compared to monobloc prostheses, an additional interface which bears the risk of fretting as well as corrosion. Failures at the neck adapter of modular prostheses have been observed for a number of different designs. It has been speculated that micromotions at the stem-neck interface were responsible for these implant failures. The purpose of this study was to investigate the influence of material combinations and assembly conditions on the magnitude of micromotions at the stem-neck interface during cyclic loading. Modular (n = 24) and monobloc (n = 3) hip prostheses of a similar design (Metha, Aesculap AG, Tuttlingen, Germany) were subjected to mechanical testing according to ISO 7206-4 (F(min) = 230N, F(max) = 2300N, f = 1Hz, n = 10,000 cycles). The neck adapters (Ti-6Al-4V or Co-Cr29-Mo alloy) were assembled with a clean or contaminated interface. The micromotion between stem and neck adapter was calculated at five reference points based on the measurements of the three eddy current sensors. The largest micromotions were observed at the lateral edge of the stem-neck taper connection, which is in accordance with the crack location of clinically failed prostheses. Titanium neck adapters showed significantly larger micromotions than cobalt-chromium neck adapters (p = 0.005). Contaminated interfaces also exhibited significantly larger micromotions (p < 0.001). Since excessive micromotions at the stem-neck interface might be involved in the process of implant failure, special care should be taken to clean the interface prior to assembly and titanium neck adapters with titanium stems should generally be used with caution.

Can the method of fixation influence the wear behaviour of ZrN coated unicompartmental mobile knee prostheses?

BACKGROUND: Modern unicompartmental knee prostheses represent a valid alternative to total knee replacement. It is known that variations in clinical alignment lead to altered biomechanics and abnormal wear. The aim of this study was to assess the influence, on wear behaviour, of two different cementing interfaces of the femoral components tested on a knee joint wear simulator. METHODS: The wear tests were run in a knee wear simulator at a frequency of 1.1 Hz for 3 million cycles in accordance with ISO 14243-3. Twelve commercial mobile GUR 1020 UHMWPE meniscus specimens articulated in between 12 cobalt-chromium-molybdenum alloy femoral and tibial components covered by a multi-layer of chromium nitride and a final layer of zirconium nitride ceramic coating to prevent ion release from the substrate. Two wear tests were performed: in the first test, each femoral component was cemented into a custom made metallic-block shaped to perfectly host it. In the second test, synthetic composite femurs received the femoral components on the basis of guidelines used in current surgery. FINDINGS: The two cementing interfaces showed a significantly different wear behaviour, quantified as mean weight loss (P<0.001). Scanning electron microscope examinations of new and tested metallic components showed macro- and micro-pores of few microns on both configurations. INTERPRETATION: The wear pattern observed at 3 million cycles showed differences between the two methods of fixation for the meniscus femoral components.

The effect of design parameters of dynamic pedicle screw systems on kinematics and load bearing: an in vitro study.

As an alternative treatment for chronic back pain due to disc degeneration motion preserving techniques such as posterior dynamic stabilization (PDS) has been clinically introduced, with the intention to alter the load transfer and the kinematics at the affected level to delay degeneration. However, up to the present, it remains unclear when a PDS is clinically indicated and how the ideal PDS mechanism should be designed to achieve this goal. Therefore, the objective of this study was to compare different PDS devices against rigid fixation to investigate the biomechanical impact of PDS design on stabilization and load transfer in the treated and adjacent cranial segment. Six human lumbar spine specimens (L3-L5) were tested in a spine loading apparatus. In vitro flexibility testing was performed by applying pure bending moments of 7.5 Nm without and with additional preload of 400 N in the three principal motion planes. Four PDS devices, "DYN" (Dynesys(®), Zimmer GmbH, Switzerland), "DSS™" (Paradigm Spine, Wurmlingen, Germany), and two prototypes of dynamic rods, "LSC" with a leaf spring, and "STC" with a spring tube (Aesculap AG, Tuttlingen, Germany), were tested in comparison to a rigid fixation device S(4) (Aesculap AG, Tuttlingen, Germany) "RIG", to the native situation "NAT" and to a defect situation "DEF" of the specimens. The instrumented level was L4-L5. The tested PDS devices comprising a stiffness range for axial stiffness of 10 N/mm to 230 N/mm and for bending stiffness of 3 N/mm to 15 N/mm. Range of motion (ROM), neutral zone (NZ), and intradiscal pressure (IDP) were analyzed for all instrumentation steps and load cases of the instrumented and non-instrumented level. In flexion, extension, and lateral bending, all systems, except STC, showed a significant reduction of ROM and NZ compared to the native situation (p < 0.05). Furthermore, we found no significant difference between DYN and RIG (p > 0.1). In axial rotation, only DSS and STC reduced the ROM significantly (p < 0.005) compared to the native situation, whereas DYN and LSC stayed at the level of the native intersegmental rotation (p > 0.05). A correlation was found between axial stiffness and intersegmental stabilization in the sagittal and frontal plane, but not in the transversal plane where intersegmental stabilization is mainly governed by the systems' ability to withstand shear loads. Furthermore, we observed the systems' capacity to reduce IDP in the treated segment. The adjacent segment does not seem to be affected by the stiffness of the fixation device under the described loading conditions.

[Preclinical evaluation of coated knee implants for allergic patients]. / Präklinische Ergebnisse beschichteter Knieimplantate für Allergiker.

BACKGROUND: 10-15% of the population show allergic reactions against skin contact to metals as nickel, cobalt or chromium and have thus a risk of not tolerating implants containing those materials. The relationship between periimplantary hypersensivity reaction and given cutaneous contact allergy is currently unknown. A new developed multilayer coating system is supposed to prevent long-term allergic reactions that may result from uncoated implants. METHODS: Stability and function (concerning bonding durability, wear and ion release to the serum) of the multilayer coating system has been examined in a test series. RESULTS: The specific architecture of the multilayer coating system evidences a very good bonding durability. The results of the test in the simulator show a reduction of wear of approximately 60% compared to the uncoated implants. Ion concentrations within the serum of the wear tests were by magnitudes lower than those measured in reference tests on uncoated components. CONCLUSION: The results of the preclinical evaluation prove that the durability and function of the multilayer coating system are as intended.

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.

[In vitro stability study of an improved implant system for minimally invasive transforaminal approach]. / In-vitro-Stabilitätsuntersuchung eines neuartigen Implantatsystems für den minimal-invasiven transforaminalen Zugang.

Calf specimens from the L3-4 and L5-6 levels were used for in vitro stability testing of a new transforaminal lumbar interbody fusion (TLIF) implant. Results were compared with those of the conventional posterior lumbar interbody fusion (PLIF) technique using two cuboid spacers. The specimens were loaded with pure moments of 10 Nm in flexion, extension, lateral bending, and axial rotation without any axial preload. They were allowed to move freely and unconstrained in all directions. In extension the PLIF implants showed slightly higher degrees of stiffness than the TLIF implant. While the conventional PLIF technique results in an increased range of motion by a factor of 2.5 after implant insertion, the TLIF approach prevents segmental destabilization in axial rotation. The facet joint arthrodesis using resorbable pins reveals biomechanically interesting results and will therefore be investigated in further studies.

[Mechanical testing of implant properties of thoracoscopic implantation of ventral spinal stabilizing systems. Comparative study with the ISO/DIS 12189-2 corpectomy model and an improved synthetic model]. / Mechanische Testung der Implantateigenschaften eines thorakoskopisch implantierbaren ventralen Wirbelsäulenstabilisierungssystems. Vergleichende Betrachtung im Korpektomiemodell nach ISO/DIS 12189-2 und in einem neuartigen synthetischen Modell.

A new modular anterior fixation system MACS TL (modular anterior construct system for the thoracic and lumbar spine) has been developed for use in thoracoscopic spondylodesis. This system demonstrates high angular stability and meets the surgical requirements for an endoscopic approach. The objective of the current study was fatigue testing of the MACS TL implant system using a corpectomy model according to ISO/DIS 12189-2 and a synthetic model recently developed by Kotani et al. [6]. The MACS TL system demonstrated good mechanical properties with a high stiffness compared to the published data reviewed. The importance of dynamic testing in a corpectomy model has been demonstrated by comparing the MACS TL plate system with an early prototype, which has not yet been clinically evaluated. The corpectomy model according to Kotani et al. offers an interesting alternative to the ISO/DIS 12189-2 test method for asymmetrically designed and antero-laterally positioned spinal implants due to the unconstrained ball joint.

Insulin-like growth factors and IGF-binding proteins in bovine seminal plasma.

Insulin-like growth factor-I (IGF-I) is an important factor for germ cell development and maturation of spermatozoa. Actions of IGFs are modulated by IGF-binding proteins (IGFBPs) that may, depending on their concentration and site of expression, inhibit or enhance effects of IGF-I. We characterized IGFs and IGFBPs in seminal plasma from bulls routinely used for artificial insemination (AI) and from bulls producing poor-quality semen (low mass and individual motility of spermatozoa). IGFs were measured by specific radioimmunoassay in 22 samples of seminal plasma from nine different AI bulls with high (> 76.8%), average (72.8-73.4%), or low (< 69.5%) nonreturn rate (NRR). IGF-I and IGF-II levels were 144 +/- 9 ng/ml (mean +/- SE; range, 79-238 ng/ml) and 144 +/- 10 ng/ml (range, 55-221 ng/ml), respectively, and did not correlate with NRRs. IGF-I concentrations in seminal plasma from bulls producing poor-quality semen (n = 10) were significantly (P < 0.05) greater (194 +/- 26 ng/ml; range, 94-370 ng/ml), whereas IGF-II levels were significantly (P < 0.05) lower (93 +/- 17 ng/ml; range, 38-183 ng/ml) than in AI bulls. Ligand blot analysis of seminal plasma for IGFBPs revealed the presence of a 38-/45-kDa doublet band and a 30-kDa IGFBP. These IGFBPs were identified as IGFBP-3 and IGFBP-5, respectively, by immunoprecipitation using specific antibodies. In addition, a low amount of IGFBP-4 was detected in bovine seminal plasma by immunoprecipitation. There was a marked difference in the activity of IGFBPs between individual bulls, with a relatively small within-bull variance. The differences in IGFBP activities did not correlate with the fertilization capacity of the bulls in vivo or in vitro nor with immunoreactive IGF-I and IGF-II levels in seminal plasma. Our results demonstrate the presence of IGFBPs in bovine seminal plasma. In contrast to human seminal plasma, high activity of IGFBP-3 was detected in seminal plasma of some bulls, suggesting species-specific regulation of IGFBP activity by proteases.