Preliminary In Vitro Wear Assessment of Ceramic Cemented Femoral Components Coupled with Polyethylene Menisci.

Success of total knee replacement (TKR) depends on the prosthetic design and materials. The use of metal components is well established with the disadvantage of allergic reactions. Ceramics have been recently proposed because of high wear resistance, excellent biocompatibility, wettability, and suitable mechanical properties. This study was aimed at investigating in vitro wear resistance of Zirconia Toughened Alumina (ZTA)/Ultra-high-molecular-weight polyethylene (UHMWPE) of TKR femoral components. An in vitro protocol was designed with the application of relevant load profile, 6-degrees-of-freedom knee simulator, and 8 × 105 cycles on the ZTA/UHMWPE configuration under bovine calf serum. Before and after wear test, the femoral components were investigated by using the Scanning Electron Microscope (SEM) and the X-Ray Diffraction (XRD) analyses, and stylus surface roughness measurements. The proposed pre-clinical test yielded repeatable results. In particular, gravimetric results showed that, after 8 × 105 cycles, the mean weight loss of the polyethylene mobile components is 5.3 ± 1.1 mg. The surface roughness measurements (Ramax) performed after the wear test showed no significant variation on the UHMWPE menisci. A slight increase of roughness has been found on the ZTA (0.02 µm before wear test, 0.28 µm after the test). SEM observations did not show significant modification of the surface morphology. Tetragonal to monoclinic phase ratio was measured by XRD before and after wear test to evaluate stability of tetragonal ZrO2 phase. Minimal conversion of tetragonal to monoclinic phase was found from 5.4 to 8%. Although this study is a preliminary evaluation limited to in vitro tests, it provides novel pre-clinical indications about the potential of ceramic TKR femoral components.

Knee Wear Assessment: 3D Scanners Used as a Consolidated Procedure.

It is well known that wear occurring in polyethylene menisci is a significant clinical problem. At this regard, wear tests on biomaterials medical devices are performed in order to assess their pre-clinical performance in terms of wear, durability, resistance to fatigue, etc. The objective of this study was to assess the wear of mobile total knee polyethylene inserts after an in vitro wear test. In particular, the wear behavior of mobile bearing polyethylene knee configurations was investigated using a knee joint wear simulator. After the completion of the wear test, the polyethylene mobile menisci were analyzed through a consolidated procedure by using 3D optical scanners, in order to evaluate the 3D wear distribution on the prosthesis surface, wear depths, wear rates, amount of material loss and contact areas. The results in terms of wear rates and wear volumes were compared with results of gravimetric tests, finding equivalent achievements.

In Vitro versus In Vivo Phase Instability of Zirconia-Toughened Alumina Femoral Heads: A Critical Comparative Assessment.

A clear discrepancy between predicted in vitro and actual in vivo surface phase stability of BIOLOX®delta zirconia-toughened alumina (ZTA) femoral heads has been demonstrated by several independent research groups. Data from retrievals challenge the validity of the standard method currently utilized in evaluating surface stability and raise a series of important questions: (1) Why do in vitro hydrothermal aging treatments conspicuously fail to model actual results from the in vivo environment? (2) What is the preponderant microscopic phenomenon triggering the accelerated transformation in vivo? (3) Ultimately, what revisions of the current in vitro standard are needed in order to obtain consistent predictions of ZTA transformation kinetics in vivo? Reported in this paper is a new in toto method for visualizing the surface stability of femoral heads. It is based on CAD-assisted Raman spectroscopy to quantitatively assess the phase transformation observed in ZTA retrievals. Using a series of independent analytical probes, an evaluation of the microscopic mechanisms responsible for the polymorphic transformation is also provided. An outline is given of the possible ways in which the current hydrothermal simulation standard for artificial joints can be improved in an attempt to reduce the gap between in vitro simulation and reality.

New Challenges in Tribology: Wear Assessment Using 3D Optical Scanners.

Wear is a significant mechanical and clinical problem. To acquire further knowledge on the tribological phenomena that involve freeform mechanical components or medical prostheses, wear tests are performed on biomedical and industrial materials in order to solve or reduce failures or malfunctions due to material loss. Scientific and technological advances in the field of optical scanning allow the application of innovative devices for wear measurements, leading to improvements that were unimaginable until a few years ago. It is therefore important to develop techniques, based on new instrumentations, for more accurate and reproducible measurements of wear. The aim of this work is to discuss the use of innovative 3D optical scanners and an experimental procedure to detect and evaluate wear, comparing this technique with other wear evaluation methods for industrial components and biomedical devices.

Micro X-Ray Computed Tomography Mass Loss Assessment of Different UHMWPE: A Hip Joint Simulator Study on Standard vs. Cross-Linked Polyethylene.

More than 60.000 hip arthroplasty are performed every year in Italy. Although Ultra-High-Molecular-Weight-Polyethylene remains the most used material as acetabular cup, wear of this material induces over time in vivo a foreign-body response and consequently osteolysis, pain, and the need of implant revision. Furthermore, oxidative wear of the polyethylene provoke several and severe failures. To solve these problems, highly cross-linked polyethylene and Vitamin-E-stabilized polyethylene were introduced in the last years. In in vitro experiments, various efforts have been made to compare the wear behavior of standard PE and vitamin-E infused liners. In this study we compared the in vitro wear behavior of two different configurations of cross-linked polyethylene (with and without the add of Vitamin E) vs. the standard polyethylene acetabular cups. The aim of the present study was to validate a micro X-ray computed tomography technique to assess the wear of different commercially available, polyethylene's acetabular cups after wear simulation; in particular, the gravimetric method was used to provide reference wear values. The agreement between the two methods is documented in this paper.

Is micro-computed tomography useful for wear assessment of ceramic femoral heads? A preliminary evaluation of volume measurements.

BACKGROUND: Wear associated with hip components represents the main clinical problem in these patients, and it is important to develop new techniques for more accurate measurements of that wear. Currently, the gravimetric method is the gold standard for assessing mass measurements in preclinical evaluations. However, this method does not give other information such as volumetric loss or surface deviation. This work aimed to develop and validate a new technique to quantify ceramic volume loss from in vitro experiments using micro-computed tomography (micro-CT). METHODS: An alumina (BIOLOX® forte) femoral head (Ø = 28 mm) was used. Mass and volume loss were approached by gravimetric method (using a four decimal place digital microbalance) and by using Skyscan 1176 microtomographic system, respectively. RESULTS: Standard error and coefficient of variance of both gravimetric and experimental groups demonstrated the reliability of the micro-CT analysis technique. CONCLUSIONS: In conclusion, the findings of the present study suggest that this new protocol could be considered an important tool for wear assessment and that we have found a reliable metrological protocol for volumetric analysis of ceramic femoral head prostheses, demonstrating that the micro-CT technique can be an important tool for wear assessment.

Reliability assessment in advanced nanocomposite materials for orthopaedic applications.

Alumina-zirconia nano-composites were recently developed as alternative bearing materials for orthopedics. Previous, preliminary reports show that such alumina-zirconia nanocomposites exhibit high crack resistance and low wear rate. In this paper, additional information is given in terms of wear, crack resistance and ageing behaviour: femoral heads are inspected after 7 million cycles of wear testing on a hip simulator, crack resistance is measured and compared to other ceramics used today in orthopedics, slow crack growth is reported under static and cyclic fatigue, and aging resistance is assessed. We also report on the load to failure of femoral heads prototypes during compression tests. This overall reliability assessment ensures a potential future development for these kinds of new nanocomposites in the orthopedic field.

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.