FE-analysis of surface stresses for the tribological system in total hip prostheses]

The implantation of a total hip prosthesis is an operation which is performed frequently due to advanced hip joint damage both in humans and in veterinary medicine in dogs. The long-term result of a hip prosthesis is mainly determined by aseptic loosening of the prosthesis; among other causes, abrasion particles of the tribological pairing are responsible for the loosening. For the analysis of the surface stresses with different tribological pairings, a finite element model was generated which was based on the CAD data of a commercial total hip prosthesis. After transmission of a physiological force in the components of the three tribological pairings ceramic/polyethylene, ceramic/ceramic and metal/polyethylene, stresses were calculated. Stresses in the ceramic/ceramic tribological pairings were conspicuously higher than in the other material pairings. In the future adapted prostheses have to be developed that ensure optimal friction and absorption characteristics of the components.     

Use of an absorbable membrane to position biologically inductive materials in the periprosthetic space of cemented joints

A device is presented that positions ultrahigh molecular weight polyethylene (UHMWPE) debris against periprosthetic bone surfaces. This can facilitate the study of aseptic loosening associated with cemented joint prostheses by speeding the appearance of this debris within the periprosthetic space. The device, composed of a 100 microm thick bioabsorbable membrane impregnated with 1.4 x 10(9) sub-micron particles of UHMWPE debris, is positioned on the endosteum of the bone prior to the insertion of the cemented orthopedic implant. An in vitro pullout study and an in vivo canine pilot study were performed to investigate its potential to accelerate "time to aseptic loosening" of cemented prosthetic joints. Pullout studies characterized the influence of the membrane on initial implant fixation. The tensile stresses (mean+/-std.dev.) required to withdraw a prosthesis cemented into canine femurs with and without the membrane were 1.15+/-0.3 and 1.54+/-0.01 MPa, respectively; these findings were not significantly different (p > 0.4). The in vivo pilot study, involving five dogs, was performed to evaluate the efficacy of the debris to accelerate loosening in a canine cemented hip arthroplasty. Aseptic loosening and lameness occurred within 12 months, quicker than the 30 months reported in a retrospective clinical review of canine hip arthroplasty.     

Development of computational wear simulation of metal-on-metal hip resurfacing replacements

As one of the alternatives to traditional metal-on-polyethylene total hip replacements, metal-on-metal hip resurfacing prostheses demonstrating lower wear have been introduced for younger and more active patients during the past decade. However, in vitro hip simulator testing for the predicted increased lifetime of these surface replacements is time-consuming and costly. Computational wear modelling based on the Archard wear equation and finite element contact analysis was developed in this study for artificial hip joints and particularly applied to metal-on-metal resurfacing bearings under simulator testing conditions to address this issue. Wear factors associated with the Archard wear equation were experimentally determined and based on the short-term hip simulator wear results. The computational wear simulation was further extended to a long-term evaluation up to 50 million cycles assuming that the wear rate stays constant. The prediction from the computational model shows good agreement with the corresponding simulator study in terms of volumetric wear and the wear geometry. The simulation shows the progression of linear wear penetrations, and the complexity of contact stress distribution on the worn bearing surfaces. After 50 million cycles, the maximum linear wear was predicted to be approximately 6 and 8 microm for the cup and head, respectively, and no edge contact was found.     

Effect of swing phase load on metal-on-metal hip lubrication, friction and wear

There is renewed interest in metal-on-metal (MOM) total hip replacements (THRs), however, variable wear rates have been observed clinically. It is hypothesised that changes in soft tissue tensioning during surgery may alter loading of THRs during the swing phase of gait leading to changes in fluid film lubrication, friction and wear. This study aimed to assess the effect of swing phase load on the lubrication, friction and wear of MOM hip replacements. Theoretical lubrication modelling was carried out using elastohydrodynamic theory. All the governing equations were solved numerically for the lubricant film thickness between the articulating surfaces under the transient dynamic conditions with low and high swing phase loads. Friction testing was completed using a single axis pendulum simulator, simplified loading cycles were applied with low and high swing phase loads. MOM hip replacements were tested in a hip simulator, modified to provide different swing phase loading regimes; a low (100 N) and a high load (as per ISO 14242-1; 280 N). Results demonstrated that the performance of MOM bearings is highly dependent on swing phase load. Hence, changes in the tension of the tissues at surgery and variations in muscle forces may increase swing phase load, reduce lubrication, increase friction and accelerate wear. This may explain some of the variations that have been observed with clinical wear rates.     

Discriminating the loosening behaviour of cemented hip prostheses using measurements of migration and inducible displacement.

In vitro pre-clinical tests of hip prostheses have not yet been developed to the extent that inferior prostheses can be 'screened-out' prior to animal or clinical trials. This paper reports the experimental part of a project to develop a pre-clinical testing platform for cemented femoral hip implants. It is based on the clinical observation (K?rrholm et al. JBJS, 76B (1994) 912-916) that higher subsidence (distal migration) correlates with early revision of hip prostheses. A protocol to measure the relative movement between implant and bone was designed to test whether or not such a measurement, if made in a laboratory, could discriminate between hip prostheses. The protocol was applied to the Lubinus SPII prosthesis (W. Link, Germany) and a Müller Curved Stem (JRI Ltd., UK)-these prostheses were chosen because they are known to have different loosening rates in vivo. Five prostheses of each design were tested. The migration, the rate-of-migration, and the inducible displacement of each prosthesis was recorded over two million cycles of loading.For each implant, rapid initial migration was found, followed by a period of steady-state migration. In the majority of cases, the prostheses migrated medially, distally and posteriorly. On average, the Lubinus migrated less than the Müller in all directions. The average Lubinus migration was less than half that of the Müller, and this difference was significant at a level of p=0.05. Inducible displacement was greater for the Müller compared to the Lubinus. Furthermore, the inducible displacement decreased over time for the majority of Lubinus prostheses whereas it increased over time for the majority of the Müller prostheses leading to the conclusion that a rapid pre-clinical test based on measurement of inducible displacement may be possible.     

Failure of total hip arthroplasties. Numerical modeling of debris formation through plastic strains

The life span of a total hip prosthesis is one of the main points on which the long-term success of arthroplasties depends. It is, by now, widely recognized that hip arthroplasty failure is mainly due to the aseptic loosening resulting from the presence of wear debris forming at the contact interface between the femoral head and the cup of the acetabulum. The size of these particles varies from a few micrometers to some tens of micrometers or more. The main aim of this study was therefore to investigate the formation of debris in the microscopic size range. For this purpose, a numerical study was carried out on various mechanisms leading to plastic deformations, which can lead to damage and wear in material. Numerical analyses were performed with a laboratory software program LMGC90, on the evolution of the plastic strains involved in various wear mechanisms on the microscopic scale.     

Deformation of the Durom Acetabular Component and Its Impact on Tribology in a Cadaveric Model—A Simulator Study

Background

Recent studies have shown that the acetabular component frequently becomes deformed during press-fit insertion. The aim of this study was to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the Durom large head metal-on-metal (MOM) total hips in simulators.

Methods

Six Durom cups impacted into reamed acetabula of fresh cadavers were used as the experimental group and another 6 size-paired intact Durom cups constituted the control group. All 12 Durom MOM total hips were put through a 3 million cycle (MC) wear test in simulators.

Results

The 6 cups in the experimental group were all deformed, with a mean deformation of 41.78±8.86 µm. The average volumetric wear rate in the experimental group and in the control group in the first million cycle was 6.65±0.29 mm³/MC and 0.89±0.04 mm³/MC (t = 48.43, p = 0.000). The ion levels of Cr and Co in the experimental group were also higher than those in the control group before 2.0 MC. However there was no difference in the ion levels between 2.0 and 3.0 MC.

Conclusions

This finding implies that the non-modular acetabular component of Durom total hip prosthesis is likely to become deformed during press-fit insertion, and that the deformation will result in increased volumetric wear and increased ion release.

Clinical Relevance

This study was determined to explore the deformation of the Durom cup after implantation and to clarify the impact of deformation on wear and ion release of the prosthesis. Deformation of the cup after implantation increases the wear of MOM bearings and the resulting ion levels. The clinical use of the Durom large head prosthesis should be with great care.     

Duration and frequency of every day activities in total hip patients.

Little knowledge about frequency and duration of daily activities in patients after total hip arthroplasty is available. Such information is required for the definition of realistic load collectives for pre-clinical testing of prostheses. It could also be helpful for the quantitative evaluation of surgery outcome with different prosthesis types. The purpose of this study was to develop and apply a system for the determination of frequency and duration of patient activities in their habitual environment and to compare the results to a clinical outcome score (Harris hip score).A portable activity monitoring system (weight 1.6 kg including batteries) was designed using a Palm top computer, 2 inclination sensors for the thigh and calf and one goniometer positioned at the knee joint. An algorithm was developed to identify frequency and duration of the activities lying, sitting, standing, walking and stair climbing from the signals of the 3 sensors. 42 patients participated in the study and were equipped with the system in the morning at their home. Datasets of 31 patients (age 62.5+/-11.5 y) covered more than 6h (9.8 +/- 1.6 h) and were included in the analysis. Prosthesis specific data as well as the Harris hip score were collected.The most frequent patient activity was sitting (44.3% of the time), followed by standing (24.5%), walking (10.2%), lying (5.8%) and stair climbing (0.4%). The median number of steps/stairs was 6048/164. The number of step cycles representing one year in vivo use should, consequently, be increased to 1.1 million. The Harris hip score (91.4 +/- 9.8) correlated significantly with the number of stairs (r(2) = 0.26, p = 0.003) and showed a positive tendency with the number of steps per day. No differences in activity levels between prosthesis specific factors were found.     

Failure of Total Hip Arthroplasties. Numerical Modeling of Debris Formation through Plastic Strains

The life span of a total hip prosthesis is one of the main points on which the long-term success of arthroplasties depends. It is, by now, widely recognized that hip arthroplasty failure is mainly due to the aseptic loosening resulting from the presence of wear debris forming at the contact interface between the femoral head and the cup of the acetabulum. The size of these particles varies from a few micrometers to some tens of micrometers or more. The main aim of this study was therefore to investigate the formation of debris in the microscopic size range. For this purpose, a numerical study was carried out on various mechanisms leading to plastic deformations, which can lead to damage and wear in material. Numerical analyses were performed with a laboratory software program LMGC90, on the evolution of the plastic strains involved in various wear mechanisms on the microscopic scale.     

Meniscal wear at a three-component total ankle prosthesis by a knee joint simulator

Despite the fundamental value of wear simulation studies to assess wear resistance of total joint replacements, neither specialised simulators nor established external conditions are available for the human ankle joint. The aim of the present study was to verify the suitability of a knee wear simulator to assess wear rates in ankle prostheses, and to report preliminary this rate for a novel three-component total ankle replacement design. Four intact 'small' size specimens of the Box ankle were analysed in a four-station knee wear simulator. Special component-to-actuator holders were manufactured and starting spatial alignment of the three-components was sought. Consistent load and motion cycles representing conditions at the ankle joint replaced exactly with the prosthesis design under analysis were taken from a corresponding mechanical model of the stance phase of walking. The weight loss for the three specimens, after two million cycles, was 32.68, 14.78, and 62.28mg which correspond to a linear penetration of 0.018, 0.008, and 0.034mm per million-cycle, respectively for the specimens #1, #2, and #3. The knee wear simulator was able to reproduce load-motion patterns typical of a replaced ankle. Motion of the meniscal bearing in between the tibial and talar components was smooth, this component remaining in place and in complete congruence with the metal components throughout the test.     

Biological impact of polyacetal particles on loosening of isoelastic stems

The aim of our study was to identify biological factors responsible for premature loosening of polyacetal hip stems. The results of histological analyses of the tissue around 11 total hip prostheses with loosened polyacetal femoral stems were compared to those obtained in a group of 11 total hip prostheses with loosened metal (CoCr) femoral components. A higher number of polymer wear particles surrounded by giant cells, more bone chips, and a more extensive necrosis were found around loosened polyacetal stems. Histomorphological characteristics of polyacetal wear particles containing BaSO(4) granules in the tissue around loosened polyacetal stems were described. Radiological evaluation of the wear of polyethylene cups suggested that elastic modulus of the stem had no influence on the wear of polyethylene cups. This study indicates that polyacetal wear particles have a great biological potential accelerating the process of loosening.     

The transport of wear particles in the prosthetic hip joint: a computational fluid dynamics investigation

The joint fluid mechanics and transport of wear particles in the prosthetic hip joint were analyzed for subluxation and flexion motion using computational fluid dynamics (CFD). The entire joint space including a moving capsule boundary was considered. It was found that particles suspended in the joint space are drawn into the joint gap between prosthesis cup and head during subluxation, which was also documented by Lundberg et al. (2007; Journal of Biomechanics 40, 1676-1685), however, wear particles remain in the joint gap. Wear particles leave the joint gap during flexion and can finally migrate to the proximal boundaries including the acetabular bone, where the particle deposition can cause osteolysis according to the established literature. Thus, the present study supports the theory of polyethylene wear particle induced osteolysis of the acetabular bone as a major factor in the loosening of hip prosthesis cups.     

Mixing and matching in ceramic-on-metal hip arthroplasty: An in-vitro hip simulator study

The clinical success of second-generation metal-on-metal hip replacement and the good tribological performance of alumina ceramic revived an interest in hip articulation as a solution to reduce wear.This study was aimed at characterizing the wear behaviour of new hybrid ceramic-on-metal bearings. In particular, this study investigated the wear behaviour of ceramic-on-metal hip components (three different diameters configurations: 28, 32 and 36 mm), not specifically proposed to be coupled, in order to compare them with ceramic-on-ceramic, which is considered to be the gold standard for wear resistance. For this purpose, the weight loss over a standard wear simulation was monitored. Moreover, scanning electronic microscope observations were used to verify if any carbides removal, for the metallic components, triggered wears debris production promoting abrasive third-body wear.After five million cycles, our results showed significantly greater wear-in ceramic-on-metal compared with ceramic-on-ceramic, and significant greater wear for the 32-mm diameter compared with the 36-mm one. Our findings showed an increase in wear for the proposed hybrid specimens with respect to that of the ceramic-on-ceramic ones confirming that even in the case of ceramic-on-metal bearings, mixing and matching could not prove effective wear behaviour, not even comparable with that of the ceramic-on-ceramic gold standard. Wear patterns and roundness tolerances certainly discourage the coupling of components not specifically intended to be coupled. Unsuitable geometrical conformity could, in fact, result in a poor dynamic behaviour and lead to clinical failure.     

Characterization of mode II-wear particles and cytokine response in a human macrophage-like cell culture.

Informations about wear particles in metallosis (mode II wear) and their effects in vitro and in vivo are limited. The aim of this study was to characterize wear particles obtained intraoperatively and to analyse their effects on cytokine response in an established human macrophage-like cell culture model. METHOD: Wear particles were obtained intraoperatively from four patients with metallosis resulting from CrCoMo/PE/TiAIV-implants (mode II wear) (3 knee, 1 hip prosthesis). After purification, particles were characterized regarding to their composition and size (particle size analyser, electron microscopy, edx-analysis, histological slices). The effects of particles on the release of cytokines (PDGF, IL-1beta, IL-8, TNF alpha) were determined in an established human macrophage-like cell culture system by ELISA-assays. RESULTS: The metal wear particles consisted of TiAIV with a mean size of 0.1 +/- 0.15 microm, independent of the prosthesis location. CrCoMo particles could not be detected. In the cell culture model 1456 x 10(8) particles per 1 x 10(6) macrophages released maximum amounts of TNFalpha (8-fold) and IL-8 and IL-1beta (5-fold) while the survival rate of the cells was more than 90 percent. A particle-dependent increase of PDGF-levels could not be detected. CONCLUSION: As already shown for mode I wear particles (contact between primary bearing surfaces), also mode II wear particles cause release of bone resorbing cytokines in a macrophage-like cell culture model. Because their local and systemic effects in vivo are still not completely understood, we recommend a complete removal of wear particles in cases of metallosis to avoid possible immunological reactions of the body as well as periprosthetic osteolysis.     

Ceramic acetabular cups for hip endoprostheses. 7: How do position of the center of rotation and the CCD angle of the shaft modify range of motion and impingement?]

The range of motion (ROM) of total hip prostheses is influenced by a number of parameters. An insufficient ROM may cause impingement, which may result in subluxation, dislocation or material failure of the prostheses. In a three-dimensional CAD simulation, the position of the centre of rotation and the CCD angle of the stem were investigated. Displacement of the centre of rotation of the femoral head may be due to wear (PE cups) or to the design of the prosthesis (ceramic cups). Stems of widely differing design have been developed and implanted. The results of the present study demonstrate that the ROM is clearly reduced by increasing penetration of the femoral head. At an inclination angle of 45 degrees, a depth of penetration of 2 mm restricts flexion by about 15 degrees, and a depth of penetration of 3 mm by about 30 degrees. At smaller angles of inclination the ROM is reduced and flexion and abduction are associated with an increased risk of impingement. With steeper acetabular cup inclinations, the risk of impingement decreases, but dislocation, the risk of rim fractures (ceramic cups), and wear and penetration rates (PE cups) increase. The CCD angle of the stem should be oriented to the anatomical situation. At high CCD angles (> 135 degrees), flexion is clearly limited, in particular when there is penetration of the femoral head. For modern total hip arthroplasty, prosthetic systems characterised by precise positioning of components, minimum wear, slightly recessed inserts, and appropriate CCD angles should be used.     

A preliminary assessment of intra-oral lubricating systems for dry mouth patients

Objective: To provide extended intra-oral delivery of a saliva substitute. Intervention: Three different types of prostheses containing saliva substitute were designed and assessed: a two-part device resembling a mandibular complete denture sealed by cobalt-samerium magnets, a one-part clear resin device for the edentate patients and a flexible mouth guard type of appliance containing a lubricant releasing bubble for the dentate patients. Setting: A teaching hospital Oral Medicine and Rheumatology Clinic. Subjects: 8 edentate and 3 dentate Sjogren Syndrome sufferers. Outcome measures: Subjective dryness after a week of wearing the lubricating appliance. Results: The majority of the subjects wore the appliances for 6–12 hours during each 24 hours. The initial dryness severity diminished after wearing the lubricating prosthesis. The patients preferred to wear the appliance at night. Conclusion: All criteria were fulfilled on designing a saliva substitute lubricating appliance and some of the subjects have worn this prosthesis successfully for up to 3 years. Particular benefit was obtained by night-time wear.     

Force track analysis of contemporary hip simulators

In an earlier paper, the authors presented the first verified method of computation of slide tracks in the relative motion between femoral head and acetabular cup of total hip prostheses. The method was applied for gait and for two hip simulator designs, and in a subsequent paper, for another eight designs. In the present paper, the track drawn by the resultant contact force, the so-called force track, was studied in depth. The variations of sliding distance, sliding velocity and direction of sliding during a cycle, all of which are important with respect to wear, were computed for gait and for 11 hip simulator designs. Moreover, the product of the instantaneous load and increment of sliding distance was numerically integrated over a cycle. This integral makes it possible to compare clinical wear rates with those produced by hip simulators in terms of a wear factor. For the majority of contemporary hip simulators, the integral has so far been unknown. The computations revealed considerable differences, which are likely to explain the substantial differences in wear produced by the simulators. With the most common head diameter, 28 mm, the ranges for sliding distance per cycle, mean sliding velocity, total change of direction of sliding and integral were: 19.7-34.3 mm, 19.7-49.0 mm/s, 360-1513 degrees, and 17.4-43.5 Nm, respectively.     

Strength requirements for internal and external prostheses

Throughout the history of development of joint replacement implants and external prostheses there have been mechanical failures due to a discrepancy between material strength, cross-sectional characteristics and the loads developed in normal or abnormal function by the patient utilising the device. Particularly for internal prostheses attention is being paid at the present time to wear characteristics and the requirements for the articulating surfaces and the volume of wear particles produced during tests simulating the use of the device within the patient. The particular importance of the wear particles is that they seem to be associated with accelerated resorption of bone at areas essential for successful fixation of the implant within it. This article will consider joint replacements at the knee and hip and external prostheses for the leg. If failure due to external trauma is ignored the loads to be considered in testing standards correspond in implants to the muscular and ligamentous forces related to the forces developed between ground and foot and to the bending moments in the structure of leg prostheses. Generally it can be assumed that the treatment of the patient following trauma is more easily accomplished and more likely to be successful if the prosthesis has failed and not the bony structure of the patient. However, the author is unaware that these devices have ever been designed to have lower intrinsic strength than the anatomical structures to which they are connected; indeed in many cases particularly for implants they are much stronger than the bone to which they are connected. The major difficulty in rational design of prosthetic devices has been uncertainty about the importance of occasionally applied loads of a high value relative to those on a frequent basis and also to the frequency of application of these overloads. In this paper consideration is given to methods of determination of load systems relevant to the mechanical performance of implanted joint replacements at the hip and the knee and external prostheses for leg amputees. New data are presented relating to walking, other daily activities and the corresponding frequency of occurrence of these. Loading data on implants obtained by various biomechanical models is compared and related to the loads actually measured by implanted transducers. The philosophy of the standardised test load systems and the performance requirements is reviewed.     

Biomechanics of below-knee amputee gait

Sagittal plane biomechanical and EMG analyses from eight below knee (B/K) amputee trials demonstrate considerably modified motor patterns from the residual muscles at the hip and knee. Five SACH fittings, two Uniaxial and one Gressinger prostheses were analysed. Moments of force and mechanical power were analysed on all eight trials and EMG profiles are reported for three of the amputees fitted with SACH prostheses. The findings can be summarized as follows: 1. All eight trials had similar internal moment of force patterns at the ankle. A dorsiflexor moment commenced at heel contact and continued for the first third of stance. The prostheses generated a plantarflexor moment for the balance of stance which increased in late stance to about 2/3 that seen in normals. 2. The two Uniaxial prostheses showed a 20% recovery of stored energy which was returned at push-off. The recovery by the Gressinger fitting was 30%. 3. For all but the Gressinger prosthesis the knee moment of force was negligible during early stance (when normals have an extensor moment), below normal in late stance and fairly normal during swing. The amputee wearing the Gressinger prosthesis had a normal but slightly reduced pattern of moments of force over the entire stride. 4. All eight trials had hyperactive hip extensors during early and mid-stance which resulted in above-normal energy generation by these concentrically contracting muscles. This compensation makes up for the loss of the major energy generation by the plantarflexors at push-off. 5. The moment of force and power patterns at the hip for all eight trials during late stance and swing were fairly normal.(ABSTRACT TRUNCATED AT 250 WORDS)