Dissociation of liner from cup in THA: does liner damage affect the risk of dissociation?

INTRODUCTION A rare catastrophic failure of modular component Total Hip Arthroplasty is dissociation between liner and cup, which has been associated with component malposition and/or impingement and seems to be more frequently associated with the Pinnacle system. The goal of this study was to evaluate the resistance of a polyethylene liner to lever-out-forces of the Pinnacle locking mechanism and the locking mechanisms of two other current cup/liner systems using a standardized testing method (ASTM). MATERIALS AND METHODS Five of each of the following cups were evaluated with their corresponding polyethylene liners: Pinnacle Multihole cup with and without intact anti-rotation tabs (ART's); Allofit-S-Alloclassic and Plasmafit Plus7 cups. The ASTM test set-up was used to evaluate the lever-out force resulting in liner dissociation for each construct. RESULTS The Pinnacle construct with intact ARTs required the greatest force (F) to achieve dissociation (263.2 ± 79.2 N) followed by the Plasmafit Plus7 (185.8 ± 36.9 N) and the Allofit-S (101.4 ± 35.3 N) constructs, respectively. However, after removal of the ARTs, the Pinnacle system required the least force to achieve dissociation (75.1 ± 22.2 N) (p < 0.001). CONCLUSIONS The intact Pinnacle system appeared the most stable in lever-out tests when compared to the other systems. However, after removal of the ARTs, the Pinnacle system required the least force for dissociation, consistent with locking mechanism failure, and suggesting that the ARTs are a critical component of the locking mechanism. Our findings are consistent with the clinical experience of dissociated Pinnacle constructs displaying damaged or missing ARTs, and that damage to these may increase risk of liner dissociation

Comparison of the Primary Stability of Porous Tantalum and Titanium Acetabular Revision Constructs.

Adequate primary stability of the acetabular revision construct is necessary for long-term implant survival. The difference in primary stability between tantalum and titanium components is unclear. Six composite hemipelvises with an acetabular defect were implanted with a tantalum augment and cup, using cement fixation between cup and augment. Relative motion was measured at cup/bone, cup/augment and bone/augment interfaces at three load levels; the results were compared to the relative motion measured at the same interfaces of a titanium cup/augment construct of identical dimensions, also implanted into composite bone. The implants showed little relative motion at all load levels between the augment and cup. At the bone/augment and bone/cup interfaces the titanium implants showed less relative motion than tantalum at 30% load (p < 0.001), but more relative motion at 50% (p = n.s.) and 100% (p < 0001) load. The load did not have a significant effect at the augment/cup interface (p = 0.086); it did have a significant effect on relative motion of both implant materials at bone/cup and bone/augment interfaces (p < 0.001). All interfaces of both constructs displayed relative motion that should permit osseointegration. Tantalum, however, may provide a greater degree of primary stability at higher loads than titanium. The clinical implication is yet to be seen

Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation

New technologies are great opportunities for personalized medicine. Custom made implants can be very helpful for patients with severe bone defects or in case of bone tumor. Through the European Union it is regulated how many possibilities and restrictions all medical devices have. Because of critical vulnerabilities a new European Medical Device Regulation (MDR) was published in May 2017 and it will enter into force in May 2020. For the manufacturers of customized products it will change the documentation of the manufacturing and tracking of serious incidents. Patients with a pelvis defect of Paprosky IIb and higher can benefit from a custom made pelvis implant, because all planning steps according to biomechanic and bone contact to the implant can be designed and proofed during a reconstruction process. With regular modular implant systems, it probably can be a trial and error procedure during the surgery according to biomechanic and a stable position of the implant. Based on the 3D-Reconstruction of CT-Scans of a patient with a Paprosky 2b pelvis defect, a personalized acetabulum implant was designed. To maintain as much bone as possible, the implant was shaped to the remaining pelvic bone stock. Additive manufacturing gives the opportunity to produce custom made single items even in a quality that ful-fills the requirements of the MDR. Modern Selective Laser Melting (SLM) and Electron Beam melting (EBM) Systems are able to produce Titanium or CoCr parts in the ISO standards for Implants (ISO 5832 ff). In this study the process chain, starting from the reconstruction, to the design and the production of a custom made acetabulum cup was run through on an exemplary CTData of one patient. With this example, it was shown that it is possible, to establish a process, that is able to address surgical needs for patients that benefit from those techniques

Pulsatile Lavage Systems with High Impact Pressure and High Flow Produce Cleaner Cancellous Bone Prior to Cementation in Cemented Arthroplasty

In cemented joint arthroplasty, state-of-the-art cementing techniques include high-pressure pulsatile saline lavage prior to cementation. Even with its outstanding importance in cementation, there are surprisingly few studies regarding the physical parameters that define pulsatile lavage systems. To investigate the parameters of impact pressure, flow rate, frequency and the cleaning effect in cancellous bone, we established a standardized laboratory model. Standardized fat-filled carbon foam specimens representing human cancellous bone were cleaned with three different high-pressure pulsatile lavage systems. Via CT scans before and after cleaning, the cleaning effect was evaluated. All systems showed a cleaning depth of at least 3.0 mm and therefore can be generally recommended to clean cancellous bone in cemented joint arthroplasty. When comparing the three lavage systems, the study showed significant differences regarding cleaning depths and volume, with one system being superior to its peer systems. Regarding the physical parameters, high impact pressure in combination with high flow rate and longer distance to the flushed object seems to be the best combination to improve the cleaning of cancellous bone and therefore increase the chances of a deeper cement penetration that is required in cemented joint arthroplasty. In summary, this study provides the first standardized comparison of different lavage systems and thus gives initial guidance on how to optimally prepare cancellous bone for cemented joint arthroplasty

Does Pressurized Carbon Dioxide Lavage Improve Bone Cleaning in Cemented Arthroplasty?

Cemented implant fixation in total joint arthroplasty has been proven to be safe and reliable with good long-term results. However, aseptic loosening is one of the main reasons for revision, potentially caused by poor cementation with low penetration depth in the cancellous bone. Aim of this prospective laboratory study was, to compare impact pressure and cleaning effects of pulsatile saline lavage to novel carbon dioxide lavage in a standardized carbon foam setup, to determine whether or not additional use of carbon dioxide lavage has any impact on cleaning volume or cleaning depth in cancellous bone. Carbon specimens simulating human cancellous bone were filled with industrial grease and then underwent a standardized cleaning procedure. Specimens underwent computed tomography pre- and post-cleaning. Regarding the impact pressure, isolated carbon dioxide lavage showed significant lower pressure compared to pulsatile saline lavage. Even though the combination of carbon dioxide lavage and pulsatile saline lavage had a positive cleaning effect compared to the isolated use of pulsatile saline lavage or carbon dioxide lavage, this was not significant in terms of cleaning volume or cleaning depth

Is TKA femoral implant stability improved by pressure applied cement? a comparison of 2 cementing techniques

Abstract Background The majority of knee endoprostheses are cemented. In an earlier study the effects of different cementing techniques on cement penetration were evaluated using a Sawbone model. In this study we used a human cadaver model to study the effect of different cementing techniques on relative motion between the implant and the femoral shaft component under dynamic loading. Methods Two different cementing techniques were tested in a group of 15 pairs of human fresh frozen legs. In one group a conventional cementation technique was used and, in another group, cementation was done using a pressurizing technique. Under dynamic loading that simulated real life conditions relative motion at the bone-implant interface were studied at 20 degrees and 50 degrees flexion. Results In both scenarios, the relative motion anterior was significantly increased by pressure application. Distally, it was the same with higher loads. No significant difference could be measured posteriorly at 20°. At 50° flexion, however, pressurization reduced the posterior relative motion significantly at each load level. Conclusion The use of the pressurizer does not improve the overall fixation compared to an adequate manual cement application. The change depends on the loading, flexion angle and varies in its proportion in between the interface zones

Rheological Behavior of Different Calf Sera before, during and after Biomechanical Testing

Due to different rheological behavior of human synovial fluid and the test mediums for in vitro examinations, wear tests cannot replicate the in vivo situation completely. The standards for wear testing indicate calf serum as in vitro test medium. However, these standards do not contain precise information on the main constituent components and the rheological properties. In this study, bovine calf serum and newborn calf serum with a protein concentration of 20 g/L, both approved for wear testing defined by the International Organization for Standardization (ISO), were characterized according to their rheological properties to detect differences before and during tribological simulation. The rheological behavior was determined at five defined intervals of a tribological test. The two test fluids differ in their rheological properties before and during the test and can therefore lead to deviating results in tribological testing. Furthermore, both test media changes considerably over test duration. At a test duration of 0.5 Mio cycles, both fluids have changed so that there is no longer any difference between them in terms of rheological properties. These changes could be attributed to denaturation and degradation of proteins. Thus, the choice of medium impacts tribological test results which should be considered for the interpretation of these studies

In Vitro Wear Behavior of Knee Implants at Different Load Levels: The Impact of the Test Fluid

Calf serum is defined as a test fluid for in vitro knee wear simulation studies in the ISO standard. However, protein degradation typically occurs during in vitro wear simulation. The current study should indicate whether increased loads change the rheological properties of the test fluid and may, therefore, lead to favorable tribological behavior and reduced wear. Three different load levels were simulated in a displacement-controlled knee wear simulation study. The gravimetric wear rates were determined, pressure measurements were performed, and the dynamic viscosity of the test fluids were analyzed after the simulation of 0.5 × 106 cycles. The lowest load level led to the lowest wear rate, and the lowest contact pressure and contact area, compared to the medium and high-load level. Although, the high-load level led to the highest contact pressure and contact area, the wear rates were comparable to the medium-load level. The rheological measurements revealed the highest dynamic viscosity for the high-load level and no differences could be found between the medium and low loading condition. To perform realistic wear simulation studies, the reproduction of the in vivo interrelationships between the shear forces and wear are necessary

Rheological Behavior of Different Calf Sera before, during and after Biomechanical Testing

Due to different rheological behavior of human synovial fluid and the test mediums for in vitro examinations, wear tests cannot replicate the in vivo situation completely. The standards for wear testing indicate calf serum as in vitro test medium. However, these standards do not contain precise information on the main constituent components and the rheological properties. In this study, bovine calf serum and newborn calf serum with a protein concentration of 20 g/L, both approved for wear testing defined by the International Organization for Standardization (ISO), were characterized according to their rheological properties to detect differences before and during tribological simulation. The rheological behavior was determined at five defined intervals of a tribological test. The two test fluids differ in their rheological properties before and during the test and can therefore lead to deviating results in tribological testing. Furthermore, both test media changes considerably over test duration. At a test duration of 0.5 Mio cycles, both fluids have changed so that there is no longer any difference between them in terms of rheological properties. These changes could be attributed to denaturation and degradation of proteins. Thus, the choice of medium impacts tribological test results which should be considered for the interpretation of these studies