ZrN-multilayer coating is clinically well established in total knee arthroplasty [1-3] and has demonstrated significant reduction in polyethylene wear and metal ion release [4,5]. The goal of our study was to analyze the biotribological behaviour of the ZrN-multilayer coating on a polished cobalt-chromium cemented hip stem. CoCr28Mo6 alloy hip stems with ZrN-multilayer coating (CoreHip®AS) were tested versus an un-coated version. In a worst-case-scenario the stems with ceramic heads have been tested in bovine serum in a severe cement interface debonding condition under a cyclic load of 3,875 N for 15 million cycles. After 1, 3, 5, 10 & 15 million cycles the surface texture was analysed by scanning-electron-microscopy (SEM) and energy-dispersive x-ray (EDX). Metal ion concentration of Co,Cr,Mo was measured by inductively coupled plasma mass spectroscopy (ICP-MS) after each test interval. Based on SEM/EDX analysis, it has been demonstrated that the ZrN-multilayer coating keeps his integrity over 15 million cycles of severe stem cemented interface debonding without any exposure of the CoCr28Mo6 substrate. The ZrN-multilayer coated polished cobalt-chromium cemented hip stem has shown a reduction of Co & Cr metal ion release by two orders of a magnitude, even under severe stem debonding and high interface micro-motion conditions. ZrN-multilayer coating on polished cobalt-chromium cemented hip stems might be a suitable option for further minimisation of Co & Cr metal ion release in total hip arthroplasty. Clinical evidence has to be proven during the next years.
Total knee arthroplasty with a rotating hinge knee with carbon-fibre-reinforced (CFR)-PEEK as an alternative bushing material with enhanced creep, wear and fatigue behaviour has been clinically established [1-4]. The objective of our study was to compare results from in vitro biotribological characterisation to ex vivo findings on a retrievals. A modified in vitro wear simulation based on ISO 14243-1 was performed for 5 million cycles on rotating hinge knee (RHK) designs (EnduRo®) out of cobalt-chromium and ZrN-multilayer ceramic coating. The rotational & flexion axles-bushings and the flanges are made of CFR-PEEK with 30% polyacrylonitrile fibre content. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN-multilayer in regard to loosening torques, microscopic surface analysis, distinction between different wear modes and classification with a modified HOOD-score has been performed. For the RHK design with the polyethylene gliding surface and bushings and flanges made out of CFR-PEEK, a cumulative volumetric wear was measured to be 12.9±3.95 mm3 in articulation to cobalt-chromium and 1.3±0.21 mm3 to ZrN-multilayer coating - a significant 9.9-fold decrease (p=0.0072). For the CFR-PEEK flexion bushing and flanges the volumetric wear rates were 2.3±0.48 mm3/million cycles (cobalt-chromium) and 0.21±0.02 mm3/million cycles (ZrN-multilayer) (p=0.0016). The 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which is in accordance to the time in vivo of 12–60 months of the retrieved RHK components [5]. The main wear modes were comparable between retrievals and in vitro specimens, whereby the size of affected area on the retrieved components showed a higher variation. For the EnduRo® RHK design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN-multilayer coating.
Beneath infection, instability and malalignment, aseptic tibial component loosening remains a major cause of failure in total knee arthroplasty (TKA) [1]. This emphasizes the need for stable primary and long-term secondary fixation of tibial baseplates. To evaluate the primary stability of cemented tibial baseplates, different pre-clinical test methods have been undergone: finite element analysis [2], static push-out [3,4] or dynamic compression-shear loading [5] until interface failure. However, these test conditions do not reflect the long-term endurance under in vivo loading modes, where the tibial baseplate is predominantly subjected to compression and shear forces in a cyclic profile [5,6]. To distinguish between design parameters the aim of our study was to develop suitable pre-clinical test methods to evaluate the endurance of the implant-cement-bone interface fixation for tibial baseplates under severe anterior (method I) and internal-external torsional (method II) shear test conditions. To create a clinically relevant cement penetration pattern a 4th generation composite bone model was customised with a cancellous core (12.5 PCF cellular rigid PU foam) to enable for high cycle endurance testing. VEGA System® PS & Columbus® CRA/PSA ZrN-multilayer coated tibial baseplates (2×12) were implanted in the customised bone model using Palacos® R HV bone cement ( An anterior compression-shear test (method II) was conducted at 2500 N for 10 million cycles and continued at 3000 N & 3500 N for each 1 million cycles (total: 12 million cycles) simulating post-cam engagement at 45° flexion. An internal-external torsional shear test (method II) was executed in an exaggeration of clinically relevant rotations [7,8] with ±17.2° for 1 million cycles at 3000 N tibio-femoral load in extension. After endurance testing either under anterior shear or internal-external torsion each tibial baseplate was mounted into a testing frame and maximum push-out strength was determined [3].Introduction
Materials & Methods
Metal ion and particle release, particularly cobalt, has become an important subject in total hip arthroplasty, as it has shown to induce metal hypersensitivity, adverse local tissue reactions and systemic ion related diseases. The purpose of the following study was compare the ion release barrier function of a zirconium nitride (ZrN) multilayer coated hip stem for cemented use, designed for patients with metal ion hypersensitivity, against its uncoated version in a test configuration simulating the worst case scenario of a severely debonded hip stem. The ZrN multilayer coating is applied on a CoCrMo hip stem and consists of a thin adhesive chromium layer, five alternating intermediate layers out of chromium nitride (CrN) and chromium carbonitride (CrCN) and a final zirconium nitride (ZrN) shielding layer [1]. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS.Introduction
Methods
Knee arthroplasty with a rotating hinge knee (RHK) prosthesis has become an important clinical treatment option for knee revisions and primary patients with severe varus or valgus deformities and instable ligaments. The rotational axle constraints the anterior-posterior shear and varus-valgus moments, but currently used polyethylene bushings may fail in the mid-term due to insufficient creep and wear resistance of the material. Due to that carbon-fibre-reinforced (CFR) PEEK as an alternativ bushing material with enhanced creep, wear and fatigue behaviour has been introduced in a RHK design [Grupp 2011, Giurea 2014]. The objective of our study was to compare results from the pre-clinical biotribological characterisation to ex vivo findings on a series of retrieved implants. In vitro wear simulation according to ISO 14243-1 was performed on rotating hinge knee devices (EnduRo® Aesculap, Germany) made out of cobalt-chromium and of a ZrN multi-layer ceramic coating for 5 million cycles. The mobile gliding surfaces were made out of polyethylene (GUR 1020, β-irradiated 30 ± 2 kGy). For the bushings of the rotational and flexion axles and the flanges a new bearing material based on CFR-PEEK with 30% PAN fiber content was used. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN multi-layer in regard to
loosening torques in comparison with initial fastening torques Optical, DSLR camera and stereo light microscope analysis distinction between different wear modes and classification with a modified HOOD-score SEM & EDX of representative samples surface roughness and depth profilometry with a focus on the four CFR-PEEK components integrated in the EnduRo® RHK design. For the rotating hinge knee design with flexion bushing and flanges out of CFR-PEEK the volumetric wear rates were 2.3 ± 0.48 mm3/million cycles (cobalt-chromium) and 0.21 ± 0.02 mm3/million cycles (ZrN multi-layer), a 10.9-fold reduction (p = 0.0016). The UHMWPE and CFR-PEEK particles were comparable in size and morphology and predominantly in submicron size [5]. The biological response to representative sub-micron sized CFR-PEEK particles has been demonstrated in vivo based on the leucoyte-endothelian-cell interactions in the synovia of a murine intra-articular knee model by Utzschneider 2010. Schwiesau 2013 extracted the frequency of daily activities in hip and knee replacement patients from literature and estimated an average of 1.76 million gait cycles per year. Thus, the 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which fits to the time in vivo of 12–60 months of the retrieved RHK devices. The in vitro surface articulation pattern of the wear simulation tests are comparable to findings on retrieved CFR-PEEK components for both types of articulations – cobalt-chromium and ZrN multi-layer coating. For the rotating hinge knee design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN multi-layer coating.
Dual modular hip prostheses were introduced to optimize the individual and intra-surgical adaptation of the implant design to the native anatomics und biomechanics of the hip. The downside of a modular implant design with an additional modular interface is the potential susceptibility to fretting, crevice corrosion and wear [1–2]. The purpose of this study was to characterize the metal ion release of a modular hip implant system with different modular junctions and material combinations in consideration of the corrosive physiological environment. One design of a dual modular hip prosthesis (Ti6Al4V, Metha®, Aesculap AG, Germany) with a high offset neck adapter (CoCrMo, CCD-angle of 130°, neutral antetorsion) and a monobloc prosthesis (stem size 4) of the same implant type were used to characterize the metal ion release of modular and non-modular hip implants. Stems were embedded in PMMA with 10° adduction and 9° flexion according to ISO 7206-6 and assembled with ceramic (Biolox® delta) or CoCrMo femoral heads (XL-offset) by three light impacts with a hammer. All implant options were tested in four different test fluids: Ringer's solution, bovine calf serum and iron chloride solution (FeCl3-concentration: 10 g/L and 114 g/L). Cyclic axial sinusoidal compressive load (Fmax = 3800 N, peak load level of walking based on in vivo force measurements [3]) was applied for 10 million cycles using a servohydraulic testing machine (MTS MiniBionix 370). The test frequency was continuously varied between 15 Hz (9900 cycles) followed by 1 Hz (100 cycles). The metal ion concentration (cobalt, chromium and titanium) of the test fluids were analysed using ICP-OES and ICP-MS at intervals of 0, 5·105, 2·106 and 10·106 cycles (measuring sensitivity < 1 µg/L).Introduction
Methods
