Gerd Huber

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.

The influence of component design, bearing clearance and axial load on the squeaking characteristics of ceramic hip articulations

Squeaking of hip replacements with ceramic-on-ceramic bearings has put the use of this material into question despite its superior wear behavior. Squeaking has been related to implant design. The purpose of this study was to determine the influence of particular acetabular cup and femoral stem designs on the incidence of squeaking and its characteristics. The dynamic behavior of the stem, head and stem assembled with head was investigated by determining their eigenfrequencies using experimental and numerical modal analysis. Four different stem and three different cup designs were investigated. Operational system vibrations resulting in audible squeaking were reproduced in a hip simulator and related to the respective component eigenfrequencies. The applied joint load and bearing clearance were varied in the clinically relevant range. Stems with lower eigenfrequencies were related to lower squeaking frequencies and increased acoustic pressure (loudness), and therefore to a higher susceptibility to squeaking. Higher load increased the squeaking frequency, while the acoustic pressure remained unchanged. No influence of the clearance or the cup design was found. Stem design was found to have an important influence on squeaking characteristics and its incidence, confirming and explaining similar clinical observations. Cup design itself was found to have no major influence on the dynamic behavior of the system but plays an important indirect role in influencing the magnitude of friction: Squeaking only occurs if the friction in the joint articulation is sufficient to excite vibrations to audible magnitudes. If friction is low, no squeaking occurs with any of the designs investigated.

Squeak in hip endoprosthesis systems: An experimental study and a numerical technique to analyze design variants

Hip endoprosthesis systems are analyzed with respect to their susceptibility to self-excited vibrations and sound or noise generation. Experimental studies reveal that certain configurations can become unstable causing exponentially growing regular high-frequency oscillations that asymptotically approach a limit-cycle with considerable amplitude. Ultimately the vibrations do also lead to the emission of sound that is perceived as squeaking or squeal. To identify dominant influence factors and critical parameters, stability analyses were conducted on the basis of finite-element modeling. The resulting numerical approach, based on the determination of complex eigenvalues and eigenvectors, is shown to be an effective tool to analyze and show differences between endoprosthesis designs with respect to their susceptibility to develop squeaking phenomenons.

Effects of parathyroid hormone on bone mass, bone strength, and bone regeneration in male rats with type 2 diabetes mellitus.

Type 2 diabetes mellitus (T2DM) is associated with increased skeletal fragility and impaired fracture healing. Intermittent PTH therapy increases bone strength; however, its skeletal and metabolic effects in diabetes are unclear. We assessed whether PTH improves skeletal and metabolic function in rats with T2DM. Subcritical femoral defects were created in diabetic fa/fa and nondiabetic +/+ Zucker Diabetic Fatty (ZDF) rats and internally stabilized. Vehicle or 75 μg/kg/d PTH(1-84) was sc administered over 12 weeks. Skeletal effects were evaluated by μCT, biomechanical testing, histomorphometry, and biochemical markers, and defect regeneration was analyzed by μCT. Glucose homeostasis was assessed using glucose tolerance testing and pancreas histology. In diabetic rats, bone mass was significantly lower in the distal femur and vertebrae, respectively, and increased after PTH treatment by up to 23% in nondiabetic and up to 18% in diabetic rats (P < .0001). Diabetic rats showed 23% lower ultimate strength at the spine (P < .0005), which was increased by PTH by 36% in normal and by 16% in diabetic rats (P < .05). PTH increased the bone formation rate by 3-fold in normal and by 2-fold in diabetic rats and improved defect regeneration in normal and diabetic rats (P < .01). PTH did not affect serum levels of undercarboxylated osteocalcin, glucose tolerance, and islet morphology. PTH partially reversed the adverse skeletal effects of T2DM on bone mass, bone strength, and bone defect repair in rats but did not affect energy metabolism. The positive skeletal effects were generally more pronounced in normal compared with diabetic rats.

Micromotions at the taper interface between stem and neck adapter of a bimodular hip prosthesis during activities of daily living.

The stem–neck taper interface of bimodular hip endoprostheses bears the risk of micromotions that can result in ongoing corrosion due to removal of the passive layer and ultimately cause implant fracture. We investigated the extent of micromotions at the stem–neck interface and the seating behavior of necks of one design made from different alloys during daily activities. Modular hip prostheses (n = 36, Metha®, Aesculap AG, Germany) with neck adapters (CoCr29Mo6 or Ti6Al4V) were embedded in PMMA (ISO 7206‐4) and exposed to cyclic loading with peak loads ranging from walking (Fmax = 2.3 kN) to stumbling (Fmax = 5.3 kN). Translational and rotational micromotions at the taper interface and seating characteristics during assembly and loading were determined using four eddy‐current sensors. Seating during loading after implant assembly was dependent on load magnitude but not on material coupling. Micromotions in the stem–neck interface correlated positively with load levels (CoCr: 2.6–6.3 µm, Ti: 4.6–13.8 µm; p < 0.001) with Ti neck adapters exhibiting significantly larger micromotions than CoCr (p < 0.001). These findings explain why high body weights and activities related to higher loads could increase the risk of fretting‐induced implant failures in clinical application, especially for Ti–Ti combinations. Still, the role of taper seating is not clearly understood.

Design parameters and the material coupling are decisive for the micromotion magnitude at the stem–neck interface of bi-modular hip implants

Several bi-modular hip prostheses exhibit an elevated number of fretting-related postoperative complications most probably caused by excessive micromotions at taper connections. This study investigated micromotions at the stem-neck interface of two different designs: one design (Metha, Aesculap AG) has demonstrated a substantial number of in vivo neck fractures for Ti-Ti couplings, but there are no documented fractures for Ti-CoCr couplings. Conversely, for a comparable design (H-Max M, Limacorporate) with a Ti-Ti coupling only one clinical failure has been reported. Prostheses were mechanically tested and the micromotions were recorded using a contactless measurement system. For Ti-Ti couplings, the Metha prosthesis showed a trend towards higher micromotions compared to the H-Max M (6.5 ± 1.6 μm vs. 3.6 ± 1.5 μm, p=0.08). Independent of the design, prostheses with Ti neck adapter caused significantly higher interface micromotions than those with CoCr ones (5.1 ± 2.1 μm vs. 0.8 ± 1.6 μm, p=0.001). No differences in micromotions between the Metha prosthesis with CoCr neck and the H-Max M with Ti neck were observed (2.6 ± 2.0 μm, p=0.25). The material coupling and the design are both crucial for the micromotions magnitude. The extent of micromotions seems to correspond to the number of clinically observed fractures and confirm the relationship between those and the occurrence of fretting corrosion.

Deformation characteristics and eigenfrequencies of press-fit acetabular cups

BACKGROUND elastic deformation of press-fitted acetabular cups during implantation provides primary stability. Excessive deformation can lead to chipping or improper seating of ceramic inlays and is dictated by cup stiffness, which also affects its vibrational characteristics. Purpose was to investigate the influence of cup design on deformation during press-fitting and on vibration properties. METHODS deformation of ten acetabular cups (with and without ceramic inlay) was tested for radial loads clinically occurring during press-fitting (0-2000N). Eigenfrequencies were measured using experimental modal analysis and related to mass and stiffness. FINDINGS the first eigenfrequency of the shells varied greatly (4-9kHz); insertion of inlays caused an increase (16-33 kHz). The range of shell stiffness was high (2.7-48.4kN/mm), increasing due to inlay insertion (124.7-376.2kN/mm). Stiffness and mass were sufficient predictors for eigenfrequencies (p<0.001,R²=0.94). INTERPRETATION the cups investigated represent a large stiffness range. Lower cup stiffness can increase primary stability but jeopardize inlay seating, and a suitable balance must be achieved by the designer. Eigenfrequencies also decrease with decreasing stiffness but were all found to lie considerably above clinically observed squeaking frequencies, indicating that these cup designs play no predominant role in the squeaking phenomenon. The observed relation between eigenfrequencies and the quotient of stiffness and mass might be used in the development of new thin walled cup designs so that their contribution to system vibrations is prevented. Presently, surgeons should be aware of the deformation characteristics of cups in order to select a suitable press-fit magnitude.

Friction-induced whirl vibration: Root cause of squeaking in total hip arthroplasty

Squeaking is reported for ceramic-on-ceramic hip arthroplasty, and risk factors leading to this phenomenon have been investigated empirically in the past, this way giving hints to when this phenomenon occurs. The aim of this study is to present an experimentally validated explanation for the dynamical mechanism underlying the squeak, i.e. a description of what happens when noise is generated. First the kinematics of the ceramic bearing couple in relative motion are reconsidered. The relative motion at the contact zone can be understood as superposition of relative rotation and translation. The relative weight of both components depends substantially on the instantaneous load vector, which primarily determines the position of the contact area, and the instantaneous relative rotation vector. For the investigated gait scenarios, both load vector and rotation axis vary strongly during the gait cycle. Second, experimental vibration analysis during squeak is performed. A pronounced micrometer scale elliptical motion of the ball inside the liner is found. It is shown that the rotational component of the relative kinematics during gait indeed leads to friction induced vibrations. We show that a generic whirl type friction induced flutter instability, also known from similar (non bio-) mechanical systems, is the root cause of the emitted squeaking noise. Based on the identified mechanism, the role of THA system parameters (materials, design), patient risk factors, as well as the role of the gait cycle, will have to be reconsidered and linked in the future to develop effective measures against squeaking.

Finite element analyses of human vertebral bodies embedded in polymethylmethalcrylate or loaded via the hyperelastic intervertebral disc models provide equivalent predictions of experimental strength

Quantitative computer tomography (QCT)-based finite element (FE) models of vertebral body provide better prediction of vertebral strength than dual energy X-ray absorptiometry. However, most models were validated against compression of vertebral bodies with endplates embedded in polymethylmethalcrylate (PMMA). Yet, loading being as important as bone density, the absence of intervertebral disc (IVD) affects the strength. Accordingly, the aim was to assess the strength predictions of the classic FE models (vertebral body embedded) against the in vitro and in silico strengths of vertebral bodies loaded via IVDs. High resolution peripheral QCT (HR-pQCT) were performed on 13 segments (T11/T12/L1). T11 and L1 were augmented with PMMA and the samples were tested under a 4° wedge compression until failure of T12. Specimen-specific model was generated for each T12 from the HR-pQCT data. Two FE sets were created: FE-PMMA refers to the classical vertebral body embedded model under axial compression; FE-IVD to their loading via hyperelastic IVD model under the wedge compression as conducted experimentally. Results showed that FE-PMMA models overestimated the experimental strength and their strength prediction was satisfactory considering the different experimental set-up. On the other hand, the FE-IVD models did not prove significantly better (Exp/FE-PMMA: R²=0.68; Exp/FE-IVD: R²=0.71, p=0.84). In conclusion, FE-PMMA correlates well with in vitro strength of human vertebral bodies loaded via real IVDs and FE-IVD with hyperelastic IVDs do not significantly improve this correlation. Therefore, it seems not worth adding the IVDs to vertebral body models until fully validated patient-specific IVD models become available.

Quantification of material loss from the neck piece taper junctions of a bimodular primary hip prosthesis. A retrieval study from 27 failed Rejuvenate bimodular hip arthroplasties

The early failure and revision of bimodular primary total hip arthroplasty prostheses requires the identification of the risk factors for material loss and wear at the taper junctions through taper wear analysis. Deviations in taper geometries between revised and pristine modular neck tapers were determined using high resolution tactile measurements. A new algorithm was developed and validated to allow the quantitative analysis of material loss, complementing the standard visual inspection currently used. The algorithm was applied to a sample of 27 retrievals (in situ from 2.9 to 38.1 months) of the withdrawn Rejuvenate modular prosthesis. The mean wear volumes on the flat distal neck piece taper was 3.35 mm(3) (0.55 to 7.57), mainly occurring in a characteristic pattern in areas with high mechanical loading. Wear volume tended to increase with time to revision (r² = 0.423, p = 0.001). Implant and patient specific data (offset, stem size, patients mass, age and body mass index) did not correlate with the amount of material loss observed (p > 0.078). Bilaterally revised implants showed higher amounts of combined total material loss and similar wear patterns on both sides. The consistent wear pattern found in this study has not been reported previously, suggesting that the device design and materials are associated with the failure of this prosthesis.