Combined wear behavior and long-term implant-bone fixation of total knee replacement: a novel in vitro set-up.

The success of a total knee replacement (TKR) strongly depends on the prosthetic design; this includes on one hand the best choice of the bearing materials to minimize wear, on the other hand a good orientation of the prosthetic components with respect to the loading directions. The aim of this study was to investigate the feasibility of a new experimental setup combining two fundamental aspects for the long-term success of knee implants: wear and micromotions. A novel procedure was used to simulate working conditions as close as possible to in vivo ones and to measure implant-bone micromotion, by means of fixing the femoral component of the prosthesis to the distal part of a synthetic femur to be tested through a knee simulator. Gravimetric wear of the tibial specimens was assessed at regular intervals. Implant-bone inducible micromotions and permanent migrations were measured at three locations throughout the test. Wear patterns on tibial specimens were characterized through a standardized protocol based on digital image analysis; fatigue damage in the cement was quantified. Some initial conditioning was noticed both in the wear process and microcracking distribution within the cement mantle. Similarity in wear tracks observed on tibial inserts and other retrieval studies, coupled with clinically consistent migration patterns for TKR, supports the efficacy of the new in vitro method presented.

Implant fixation in knee replacement: preliminary in vitro comparison of ceramic and metal cemented femoral components.

Improved wear resistance in total knee replacement (TKR) is a suitable goal. Whereas the use of metal components is well established, mechanical loosening in recently introduced ceramic components are a cause of concern. The scope of this work was to test in vitro whether ceramic TKR femoral components are more prone to mechanical loosening than metal ones. Composite femurs were implanted with commercially available TKR metal components, and with ceramic components having identical shape to the metal ones. Implanted femurs were tested on a knee simulator for up to 5 x 10(-6) cycles. Inducible micromotions and permanent migrations were recorded throughout the test. The cement layers were inspected for signs of damage or fracture. Micromotions and migrations were similar for metal and ceramic components: their magnitude and trend over time indicated that no implant was becoming loose. When there were statistically significant differences, the ceramic components were more stable than the metal ones. When the cement layers were inspected, a few short cracks were observed; most such cracks appeared during the first cycles, while no further damage occurred in the rest of the test. The type of damage found for both the metal and the ceramic components is compatible with well-fixed implants after long-term cycling. Altogether, no remarkable difference was found between the metal and ceramic components. Therefore, this study rejects the hypothesis that ceramic TKR femoral components are more prone to mechanical loosening. Although this study had a limited sample size, it provides novel pre-clinical indications about the potential of ceramic TKR femoral components.

Sensitivity to implant materials in patients with total knee arthroplasties.

Materials used for total knee arthroplasty (TKA), may elicit an immune response whose role in the outcome of the arthroplasty is still unclear. The aim of this study was to evaluate the frequency of sensitization in patients who had undergone TKA, and the clinical impact of this event on the outcome of the implant. Ninety-four subjects were recruited, including 20 patients who had not yet undergone arthroplasty, 27 individuals who had a well-functioning TKA, and 47 patients with loosening of TKA components. Sensitization was detected by using patch testing including haptens representative of cobalt-based alloys (CoCrMo), titanium-based alloys (TiAlV), and bone cements. The frequency of positive skin reactions to metals increased significantly after TKA, either stable or loosened (No Implant 20%; Stable TKA 48.1%, p=0.05; Loosened TKA 59.6%, p=0.001, respectively). We found a higher frequency of positive patch testing to vanadium in patients who had a Stable TKA with at least one TiAlV component (39.1%, p=0.01). The medical history for metal allergy seems to be a risk factor, because the TKA failure was fourfold more likely in patients who had symptoms of metal hypersensitivity before TKA. The prognostic value was supported by survival analysis, because in these individuals the outcome of the implant was negatively influenced (the logrank test Chi square 5.1, p=0.02). This study confirms that in patients with a TKA the frequency of positive patch testing is higher than in the normal population, although no predictive value is attributable to the sensitization because patch testing was not able to discriminate between stable and loose implants. On the contrary, the presence of symptoms of metal allergy before implantation should be taken into account as a potential risk factor for TKA failure.

A new method of in vitro wear assessment of the UHMWPE tibial insert in total knee replacement.

The wear of the ultra-high-molecular-weight polyethylene (UHMWPE) tibial insert was determined using a four-station knee simulator. The bearings were subjected to flexion/extension (between 0 and 58 degrees ), anterior-posterior translation (between 0 and -5.2 mm), internal-external rotation (between -1.9 degrees and +5.7 degrees ), and a maximum axial load of 2.6 KN, as per ISO 14243-1,2,3. The wear tests were run at a frequency of 1.1 Hz for 5 million cycles, and the wear of the inserts (n = 3) was determined using the gravimetric method. The novelty of the study was a special setup developed to simulate, as realistically as possible, in vivo conditions; this involved fixing the femoral component to the distal end of a synthetic femur model by a qualified orthopedic surgeon using an approved method. After 5 million cycles, the mean weight losses were 11.16, 19.74, and 12.61 mg for specimens #1, #2, and #3, respectively. Visual and nondestructive inspections for each of the test specimens showed similar wear tracks and these were very similar to those seen on inserts retrieved after 2 years in vivo. These results show the efficacy of the new in vitro UHMWPE wear assessment method. Furthermore, a comparison between the present in vitro results and those reported in a relevant previous study provide some insight into the influence of the method used to fix the femoral component to the simulator on the wear magnitude and patterns of the tibial insert.

Biological and biomechanical effects of vancomycin and meropenem in acrylic bone cement.

Antibiotic-loaded bone cement is extensively used in joint arthroplasty, but increasing bacteria resistance against common antibiotics has lead to a demand for alternative drugs. However, bone cement containing new additives must be characterized both biologically and mechanically. This study evaluated elution kinetics, antibacterial activity, and mechanical properties for cement loaded with vancomycin and/or meropenem. The presence of meropenem broadened the antibacterial spectrum and enhanced the elution of vancomycin. The mechanical properties were negatively affected by 1.0 g of vancomycin, but these detrimental effects were acceptable when only 0.5 g of vancomycin were added to a cement containing 0.5 g of meropenem. Further investigations on this formulation with adjusted antibiotic amounts are, however, necessary to reach the optimal compromise between the antibacterial and the mechanical properties of the bone cement.

Vancomycin and meropenem in acrylic cement: elution kinetics of in vitro bactericidal action.

The Authors present a paper with a dual goal: in vitro evaluation of the elution of vancomycin and monitoring of its bactericidal action when the antibiotic is used in acrylic cement. Discs of cement with different concentrations of vancomycin alone or combined with meropenem were prepared. To assess the elution of vancomycin the discs were kept in physiological solution and periodically sampled for five weeks. The bactericidal action was assessed by putting the antibiotic discs in contact with colonies of Staphylococcus, Enterococcus, Pseudomonas and Escherichia coli. Two combinations of antibiotic-loaded cement were tested: the first one to act as a spacer and the second to stabilise the revision prosthesis.

Controlled release of vancomycin from cross-linked gelatine.

This paper explores the possibility of using biodegradable cross-linked gelatines as antibiotic devices for a long-term elution (80 days). Capillary electrophoresis (CE) has been utilized to evaluate the mass percentage of vancomycin and gelatine contemporary released from differently cross-linked vancomycin loaded gelatine samples in an elution time ranging from 24 to 1920 h. While the solubilization kinetic of gelatine samples differently cross-linked can be very close described by the simplified Higuchi model, the vancomycin release kinetic is contemporary governed by both the Fickian diffusion process trough the gelatine matrix network and the dissolution process of the matrix due to its degradation. Comparing the antibiotic eluting kinetics from gelatine at diverse cross-linking degree we observed that the degradation of the proteic matrix appears to have a minor influence in the drug release control. Vancomycin released from all the gelatine partially cross-linked samples results active against Staphylococcus aureus and Streptococcus faecalis which represent the most pathogens commonly isolated in orthopaedic infections. Vancomycin overcomes the minimum inhibitory concentration for both the bacteria in the whole range of elution time. Cross-linked gelatine devices appear to represent a useful biodegradable delivery system for local anti-infective therapy in arthoplasty.

Mechanical effects of the use of vancomycin and meropenem in acrylic bone cement.

BACKGROUND: The increasing resistance of certain bacteria to antibiotics commonly used in bone cements has led to a demand for alternative antibacterial agents. The antibiotics added to bone cements may, however, have detrimental effects on the mechanical properties of the cement. MATERIAL AND METHODS: We evaluated the mechanical effects of adding vancomycin and meropenem to bone cement by compression, bending and fatigue tests. RESULTS: Addition of vancomycin at a concentration of up to 2.5% (w/w) had no effect on the compressive strength. Bending and fatigue strength were negatively affected by vancomycin but not by meropenem. INTERPRETATION: A cement containing 1.25% vancomycin and 1.25% meropenem might be an interesting compromise between the introduction of antibacterial properties and preservation of the mechanical properties. With this concentration of additives the compressive strength and the fatigue strength remain unchanged, while the bending strength (-14%) and the bending modulus (-9%) are only slightly reduced and remain above the limits set by the ISO5833 standard.