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Background: Implant safety is a topic gaining more and more public interest. Implants are safety relevant medical devices which in the case of failure can lead to life-threatening situations., Objectives: A well-founded failure analysis requires expert knowledge not only of materials and implant design but also a qualified explantation procedure and storage conditions., Methods: A selective literature search was carried out putting the main emphasis on implant failure analysis supplemented with own investigations., Results: The reasons for implant breakdown are mostly failures of materials and in the manufacturing process. In some cases false material combinations can lead to tribocorrosion effects under cyclic loading., Conclusion: The increased level of knowledge gained from complex analyses of failed implants produces valuable evidence for better quality management.

Precise diagnosis of loosening of endoprosthetic implants plays an important role in timely, adequate treatment. However, today's diagnostic tools, mainly radiological evaluation, do not yield satisfactory results. Therefore, a new approach based on the transmission of an internally generated combined acoustic and vibration signal, was investigated. For signal generation, a magnetic oscillator which impinges inside an implant component, can be used. The signal can be detected by an external accelerometer being positioned on the skin surface. Differences in the signal generated result from varying degrees of implant fixation. This principle was tested in seven porcine foreleg specimens with a custom implant. Influence of the measurement location at the porcine skin and different levels of fixation were investigated (pressfit, slight loosening, advanced loosening), with regard to the pull-out strength. Evaluation of different parameters, especially the frequency spectrum resulted in differences of up to 12% for the comparison between pressfit and slight loosening, and 30% between pressfit and advanced loosening. A significant correlation between the measured frequency and the pull-out strength for different levels of fixation was found. Thus, the novel diagnostic method shows potential for the precise detection of implant loosening. Further work is required to determine the sensitivity and specificity of the proposed system in animal experiments., (Copyright © 2013 IPEM. Published by Elsevier Ltd. All rights reserved.)

Currently, imaging methods are used to diagnose loosening of endoprosthetic implants, but fail to achieve 100% accuracy. In this study, a passive sensor array which is based on the interaction between magnetic oscillators inside the implant and an excitation coil outside the patient was investigated. The excited oscillators produce sound in the audible range, which varies according to the extent of loosening. By performing several experimental tests, the sensor array was optimized to guarantee reproducible and selective excitation of the sound emission. Variation in the distance between the oscillators demonstrated a definite influence on the quality of the generated sound signal. Furthermore, a numerical design analysis using the boundary element method was generated for consideration of the magnetic field and the selectivity of the oscillators during excitation. The numerical simulation of the coil showed the higher selectivity of a coil with a C-shape compared to a cylindrical coil. Based on these investigations, the passive sensor system reveals the potential for detection of implant loosening. Future aims include the further miniaturization of the oscillators and measurements to determine the sensitivity of the proposed sensor system.

The main reason for the revision of total hip replacements is aseptic loosening, caused by stress shielding and wear particle induced osteolysis. In order to detect an implant loosening early, the osseointegration of endoprosthetic implants must be measured exactly. Currently applied diagnostic methods, such as standard radiographs and clinical symptomatology, often result in an imprecise diagnosis. A novel radiation-free method to improve the diagnostic investigation of implant loosening is presented. The osseointegration of an implant can be identified using mechanical magnetic sensors (oscillators), which impinge on small membranes inside an implant component, e.g., the femoral hip stem. The maximum velocity after impingement of the oscillator depends on the osseointegration of the implant. Excitation of the oscillator is realized by a coil outside the human body. Another external coil is used to detect the velocity of the oscillator. To demonstrate the principle of the novel loosening sensor, an overdimensioned test device was designed to measure simulated loosening phases in the first experimental tests with different material layers. The overdimensioned test device of the loosening sensor showed significant differences in the various phases of fixation. Analysis of the membrane without any material layer in the case of advanced loosening resulted in a 23% higher maximum velocity compared to an attached artificial bone layer. Based on these preliminary results, the sensor system shows potential for the detection of implant loosening. Moreover, the proposed system could be used in experimental applications to determine the quality of bioactive coatings and new implant materials.

The femoral components of the total knee replacements are generally made of metal. In contrast, ceramic femoral components promise improved tribological and allergological properties. However, ceramic components present a risk of failure as a result of stress peaks. Stress peaks can be minimised through adequate implant design, proper material composition and optimum force transmission between bone and implant. Thus, the quality of the implant fixation is a crucial factor. The objective of the present study was to analyse the influence of the cement layer thickness on stress states in the ceramic femoral component and in the femur. Two- and three- dimensional finite element analyses of an artificial knee joint with cement layers of different thickness and with an unbalanced cement layer thickness between the ceramic femoral component and the femur were performed. Higher stress regions occurred in the area of force transmission and in the median plane. The maximum calculated stresses were below the accepted tensile strength. Stresses were found to be lower for cement layer thickness of <2.0 mm.

The success and long-term survival rates of modern joint arthroplasty leads to a high patient satisfaction and, together with its technical improvements, has broadened the indications to an increasingly younger population. Limitations to the established systems are the long-term survival rates, which are mainly influenced by wear of the articulating parts and the resulting problems. Beside "classic" long-stemmed cemented shafts articulating with metal against polyethylene, short-stemmed or cup designs with a hard-hard self pairing are increasingly used in total hip arthroplasty. This paper reflects the current state of the art in joint arthroplasty for younger patients with the focus on wear couples and discusses future perspectives. Special interest is focused on the advantages and disadvantages of ceramic bearings, problems with allergies to implant components and the design of endoprostheses with regard to avoidance of impingement.

Possible causes for failure of total knee endoprostheses represent wear, malpositioning, maldimensioning and inadequate design of the implant components, manufacturing defects, material fatigue, corrosion, overloading, infection, and allergy against implant materials. There is a broad spectrum of methodical approaches for the analysis of failure cases. Substantial information for the damage analysis is provided by clinical and intraoperative findings, photo documentation, radiographic course as well as all-solid, physical and histological investigations. Principal purposes of damage analysis are the avoidance of further damage events and the gain of information for improvement of implant design and material as well as the optimisation of the biocompatibility of implants and wear products. Both a detection system of incidents and implant failures as well as a complete data collection enables early identification of system-specific, accumulated cases of implant failure.

Reliable confirmation of periprosthetic infection after total knee arthroplasty is a diagnostic challenge. The present work reviews published data evaluating the available diagnostic tools. Erythrocyte sedimentation rate and C-reactive protein serum levels are relatively sensitive methods with rather low specificity towards periprosthetic infection and are mainly applied to exclude infection. Studies evaluating scintigraphic methods--especially white cell scans--provide inconsistent data with varying accuracy. Consequently, white cell scans cannot be recommended as standard methods. Immunoscintigraphy with antigranulocyte antibodies and FDG-PET scans demonstrated promising results with particularly high sensitivities, but have to be validated in larger studies. Microbiological evaluation of joint aspirates proved high specificity for periprosthetic infection. However, an average of 20% of infected cases remained undetected. Nevertheless, aspiration is widely recommended for preoperative isolation of the infecting organism. Intraoperative frozen sections demonstrated excellent specificity with good sensitivity. The real accuracy of intraoperative culture and permanent histology cannot be determined due to the missing golden standard; however, a combination of both methods is recommended to define the final diagnosis. Large studies validating both methods and criteria for the final diagnosis of periprosthetic infection are necessary to optimize the diagnostic algorithm.

Aim: Recurrent dislocation after total hip replacement is a severe complication, which requires specific treatment and implants. The purpose of the present study was to compare a constraint liner with an elevated rim and standard liner regarding their range of motion and dislocation stability., Method: With a test device, range of motion until impingement (ROM (Imp)) and dislocation (ROM (Lux)) were experimentally analyzed using the above-mentioned insert types of a commercial total hip system. On the basis of movement combinations associated with dislocation, the ROM was determined. Further measuring parameter was the resisting moment against subluxation of the femoral head., Results: The constraint liners showed clear restriction of the movements "internal rotation combined with 90 degrees flexion and 0 degrees adduction" and "external rotation with 10 degrees extension and 15 degrees adduction" of up to 20 degrees compared to the neutral liner. ROM (Imp) was only decreased by about 8 degrees with the elevated-rim liner. The constraint liners revealed the highest resisting moments in subluxation, however, at adequate orientation in the acetabular cup the elevated-rim liners provided a higher ROM (Lux) of up to 12 degrees. Both designs were superior to the neutral liner at retroversion and steep cup position regarding resisting moment and ROM (Lux)., Conclusion: In case of insufficient soft tissue tension the use of constraint liners may increase the dislocation stability, however, in contrast to elevated-rim liners the impingement-free movement interval is clearly reduced. Thus, material damage and high shear stress in the bone interface can result. Therefore, constraint liners should only be used in exceptional cases.

After total hip replacement an insufficient range of motion (ROM) can lead to contact between femoral neck and rim of the cup (= impingement) causing dislocation and consecutive material failure. The purpose of this study was to analyse the influence of different wear couples on the ROM and stability against dislocation. By means of a special testing device the ROM until impingement, the ROM until dislocation as well as the resisting moment against levering the head out of the cup were experimentally determined. Various total hip systems with cup inserts made of ceramic and polyethylene were comparatively examined in different implant positions. Maximum resisting moment as well as the ROM until impingement and dislocation were clearly influenced by the implant position. Furthermore, the stability against dislocation was affected by design parameters, whereas in the case of appropriate implant position differing wear couples (metal-on-polyethylene vs. ceramic-on-ceramic) had a minor impact. However, as shown by tests under lubricant conditions, ceramic-on-ceramic couples provided less dislocation stability in unfavourable implant position in comparison to metal-on-polyethylene. Therefore, ceramic-on-ceramic couples should only be applied in the case of optimised implant orientation preventing impingement and dislocation with subsequent material failure like chipping off or breakage.

Dislocation of the artificial joint is a serious complication of total hip replacement. Various factors with an influence on dislocation stability were determined clinically. Our goal was to develop a method for evaluating experimentally the parameters implant design, position and the load situation for their influence on joint stability. With the newly developed testing device the range of motion to impingement and to dislocation can be determined at different implant positions. In addition, the rotational moments on subluxation, i.e. the "levering out" of the femoral head, can be determined. By way of example several hip implants were examined during movements associated with dislocation, e.g. (internal-)rotation in 90 degrees flexion and 0 degrees adduction as well as with (external-)rotation in combination with 10 degrees extension and 15 degrees adduction. Irrespective of implant design and position, the following movement phases can be differentiated: undisturbed motion, impingement, subluxation and, finally, complete dislocation of the head. On the basis of the range of motion of the specific phases, the moments occurring and the direction of dislocation, different implant systems can be compared. In this study the influence of the head diameter on the dislocation stability of the hip endoprosthesis is shown. With the aid of the model presented herein, a data set showing the most favourable and/or most dislocation stable implant position can be acquired for different combinations of the implant components. Additionally, useful information for implant design can be deduced and applied to new developments and/or modifications of existing implant components.

Background: Fractures of the condylar head are traditionally managed by closed techniques, despite a considerable rate of dysfunctional problems. PDS pin osteosynthesis (presented by Rasse 1992) via a preauricular approach failed to become established as a standard procedure due to a lack of stability. Alternatively, mini- or microplating, as performed in our patients (101 condylar head fractures between 1993 and 2000), showed high-grade limitations of translatory movements in about 30% due to scarification after loosening of osteosynthesis materials. The aim of this study was to establish an efficient procedure for achieving a functionally stable and atraumatic osteosynthesis., Methods: For the definition of a suitable procedure, models of the mandible (standardized fractures, types A, B, and C) were osteosynthesized (six samples for each type of fracture and type of screw), each with three PDS pins, 2.0 mm resorbable, 2.0 cortical, 1.7 and 1.2 mm small fragment screws, and exposed to increasing loads in centric (0-20-35 mm opening) and eccentric (35 mm opening) condylar positions. A computerized biomechanical test stand allowed a dynamic simulation of chewing forces (16 hydraulic drives). The resulting fracture gaps were measured without contact by a motion capture system., Results: Within physiological limits, only 1.7 small fragment and 2.0 mm cortical screws were able to bear occlusal loadings up to 200 N (1.2 mm small fragment screws up to 150 N, resorbable 2.0 mm screws up to 100 N, and PDS-pins up to 50 N). In a pullout experiment (condylar spongious bone of young pigs, aged 4-6 months), 1.7 mm small fragment screws showed superior retention. A consecutively developed small fragment screw-system has been applied clinically in 74 condylar head fractures (58 patients). After removal of osteosynthesis material, 41 of 49 TM joints have so far shown complete restitution., Conclusions: The newly developed osteosynthesis system using a retroauricular approach based on 1.7 mm small fragment screws makes maxillomandibular immobilization unnecessary. The extra-articular position of the screw heads prevents scar-induced articular limitations. Preexisting degenerative alterations of the TMJ soft tissues, however, will affect functional results adversely.

Due to modular design today's total hip endoprostheses provide the choice of different bearing surfaces. Particle-induced osteolysis is the major reason for implant failure. Therefore, minimization of wear rates is the essential factor for the improvement of long-term function of the implants. The bearing couple ceramic-on-ceramic offers a linear wear rate of about 0.005 mm/year. That is an essential prerequisite for successful treatment of young and active patients. Ceramic femoral heads and taper fixation became standard. After some problems in the 1970s, manufacturers achieved all kinds of improvements. Surgeons learned how to handle ceramic femoral heads correctly. Nowadays ceramic heads are reliable implants. Ceramic inserts have been used since the mid-1990s. Some acetabular systems with ceramic inserts are used in clinical studies, some are approved. Complications with ceramic inserts are rare, e.g., fracturing or chipping off. Mostly those problems are due to mishandling. In this study some clinical failures are analyzed. Recommendations how to improve the handling of ceramic inserts are proposed and discussed.

After total hip replacement, some cemented titanium stems show above-average early loosening rates. Increased release of wear particles and resulting reaction of the peri-prosthetic tissue were considered responsible. The objective was to develop a test method for analysing the abrasive wear behaviour of cemented stems and for generating wear particles at the interface with the bone cement. By means of the novel test device, cemented hip stems with different designs, surface topographies and material compositions using various bone cements could be investigated. Before testing, the cemented stems were disconnected from the cement mantle to simulate the situation of stem loosening (debonding). Subsequently, constant radial contact pressures were applied on to the stem surface by a force-controlled hydraulic cylinder. Oscillating micromotions of the stem (+/- 250 microm; 3 x 10(6)cycles; 5 Hz) were carried out at the cement interface initiating the wear process. The usability of the method was demonstrated by testing geometrically identical Ti-6A1-7Nb and Co-28Cr-6Mo hip stems (n= 12) with definite rough and smooth surfaces, combined with commercially available bone cement containing zirconium oxide particles. Under identical frictional conditions with the rough shot-blasted stems, clearly more wear particles were generated than with the smooth stems, whereas the material composition of the hip stems had less impact on the wear behaviour.

Carbon fiber-reinforced plastics have been used clinically as an implant material for different applications for over 20 years.A review of technical basics of the composite materials (carbon fibers and matrix systems), fields of application,advantages (e.g., postoperative visualization without distortion in computed and magnetic resonance tomography), and disadvantages with use as an implant material is given. The question of the biocompatibility of carbon fiber-reinforced plastics is discussed on the basis of experimental and clinical studies. Selected implant systems made of carbon composite materials for treatments in orthopedic surgery such as joint replacement, tumor surgery, and spinal operations are presented and assessed. Present applications for carbon fiber reinforced plastics are seen in the field of spinal surgery, both as cages for interbody fusion and vertebral body replacement.

Aim: While the importance of stability of endoprosthetic surface structures has been recognized for some time there is a lack of comparative surveys and assessment indices that would permit comparison and improvement of surfaces on cementless endoprostheses., Method: Using separately produced, systematically mounted specimen pieces of endoprosthetic surfaces with isolated non-linked elements of varying shapes and sizes, stability parameters and stability behaviour are described. Results of tripode-structures are compared to spherical surfaces., Result: These investigations show clearly that geometrical attributes, the orientation and the contact of surface elements to the endoprosthetic stem influence the stability considerably more than the size of these surface elements., Conclusion: Using tripode-elements with different orientation, size and density, a differentiated formation of cementless endoprosthetic surfaces is possible.