Long-term evaluation of a compliant cushion form acetabular bearing for hip joint replacement: a 20 million cycles wear simulation.

Soft bearing materials that aim to reproduce the tribological function of the natural joint are gaining popularity as an alternative concept to conventional hard bearing materials in the hip and knee. However, it has not been proven so far that an elastic cushion bearing can be sufficiently durable as a long term (∼20 years) articulating joint prosthesis. The use of new bearing materials should be supported by accurate descriptions of the implant following usage and of the number, volume, and type of wear particles generated. We report on a long-term 20 million cycle (Mc) wear study of a commercial hip replacement system composed of a compliant polycarbonate-urethane (PCU) acetabular liner coupled to a cobalt-chromium alloy femoral head. The PCU liner showed excellent wear characteristics in terms of its low and steady volumetric wear rate (5.8-7.7 mm(3)/Mc) and low particle generation rate (2-3 × 10(6) particles/Mc). The latter is 5-6 orders of magnitude lower than that of highly cross-linked polyethylene and 6-8 orders of magnitude lower than that of metal-on-metal bearings. Microscopic analysis of the implants after the simulation demonstrated a low damage level to the implants' articulating surfaces. Thus, the compliant PCU bearing may provide a substantial advantage over traditional bearing materials.

Chondroprotective effects of a polycarbonate-urethane meniscal implant: histopathological results in a sheep model.

PURPOSE: injury or loss of the meniscus generally leads to degenerative osteoarthritic changes in the knee joint. However, few surgical options exist for meniscal replacement. The goal of this study was to examine the ability of a non-degradable, anatomically shaped artificial meniscal implant, composed of Kevlar-reinforced polycarbonate-urethane (PCU), to prevent progressive cartilage degeneration following complete meniscectomy. METHODS: the artificial meniscus was implanted in the knees of mature female sheep following total medial meniscectomy, and the animals were killed at 3- and 6-months post-surgery. Macroscopic analysis and semi-quantitative histological analysis were performed on the cartilage of the operated knee and unoperated contralateral control joint. RESULTS: the PCU implants remained well secured throughout the experimental period and showed no signs of wear or changes in structural or material properties. Histological analysis showed relatively mild cartilage degeneration that was dominated by loss of proteoglycan content and cartilage structure. However, the total osteoarthritis score did not significantly differ between the control and operated knees, and there were no differences in the severity of degenerative changes between 3 and 6 months post-surgery. CONCLUSION: current findings provide preliminary evidence for the ability of an artificial PCU meniscal implant to delay or prevent osteoarthritic changes in knee joint following complete medial meniscectomy.

MRI-based characterization of bone anatomy in the human knee for size matching of a medial meniscal implant.

Allograft or synthetic menisci have been suggested as a means to restore contact pressures following meniscectomy. However, when the natural meniscus is severely damaged/absent, the necessary size cannot be determined according to the recipient size and there is a need to estimate it from magnetic resonance imaging (MRI) of the contralateral knee or the injured knee bones. The use of the contralateral-knee for size matching is problematic due to economic and practical reasons. Hence, there are significant advantages for a sizing algorithm based only on the candidate knee geometry. The aim of this study is to characterize midrange values and variability of knee dimensions and to develop a set of mathematical relations representing knee dimensions using a minimum of imaging-based bone measurements. Tibia, femur, and meniscus measurements were taken in 118 MRI scans and used to develop a representative parametric knee model in which all dimensions are expressed using tibia plateau width. The model was verified by comparing the predicted values to direct MRI measurements for 20 additional subjects by means of the Pearson correlation and Bland and Altman (1986, "Statistical Methods for Assessing Agreement Between Two Methods of Clinical Measurement," Lancet, 1, pp. 307-310) plot. Anatomical parameters in the male knee were significantly larger (∼17%) compared with corresponding female measurements. However, most relations between tibia, femur, and meniscus measurements (43/56) were not significantly different between male and female populations (p ≥ 0.05), indicating that differences between male and female joints are generally related to scaling and not shape. Dimensions predicted by the knee model were in a good agreement with dimensions measured directly from the MRI (R(2)>0.96) and the Bland and Altman plot indicated that ∼95% of data points were well within the ± 2 standard deviation lines of agreement. The model proposed in this study is advantageous in being able to describe typical knee proportions for a given tibial width and can be used to predict the dimensions of a candidate knee based on a single measurement. The anatomical/anthropometric data presented in the study can be utilized in a sizing algorithm for artificial meniscal implants or in the design of artificial meniscus prostheses.

Design of a free-floating polycarbonate-urethane meniscal implant using finite element modeling and experimental validation.

The development of a synthetic meniscal implant that does not require surgical attachment but still provides the biomechanical function necessary for joint preservation would have important advantages. We present a computational-experimental approach for the design optimization of a free-floating polycarbonate-urethane (PCU) meniscal implant. Validated 3D finite element (FE) models of the knee and PCU-based implant were analyzed under physiological loads. The model was validated by comparing calculated pressures, determined from FE analysis to tibial plateau contact pressures measured in a cadaveric knee in vitro. Several models of the implant, some including embedded reinforcement fibers, were tested. An optimal implant configuration was then selected based on the ability to restore pressure distribution in the knee, manufacturability, and long-term safety. The optimal implant design entailed a PCU meniscus embedded with circumferential reinforcement made of polyethylene fibers. This selected design can be manufactured in various sizes, without risking its integrity under joint loads. Importantly, it produces an optimal pressure distribution, similar in shape and values to that of natural meniscus. We have shown that a fiber-reinforced, free-floating PCU meniscal implant can redistribute joint loads in a similar pattern to natural meniscus, without risking the integrity of the implant materials.

Wear rate evaluation of a novel polycarbonate-urethane cushion form bearing for artificial hip joints.

There is growing interest in the use of compliant materials as an alternative to hard bearing materials such as polyethylene, metal and ceramics in artificial joints. Cushion form bearings based on polycarbonate-urethane (PCU) mimic the natural synovial joint more closely by promoting fluid-film lubrication. In the current study, we used a physiological simulator to evaluate the wear characteristics of a compliant PCU acetabular buffer, coupled against a cobalt-chrome femoral head. The wear rate was evaluated over 8 million cycles gravimetrically, as well as by wear particle isolation using filtration and bio-ferrography (BF). The gravimetric and BF methods showed a wear rate of 9.9-12.5mg per million cycles, whereas filtration resulted in a lower wear rate of 5.8mg per million cycles. Bio-ferrography was proven to be an effective method for the determination of wear characteristics of the PCU acetabular buffer. Specifically, it was found to be more sensitive towards the detection of wear particles compared to the conventional filtration method, and less prone to environmental fluctuations than the gravimetric method. PCU demonstrated a low particle generation rate (1-5×106 particles per million cycles), with the majority (96.6%) of wear particle mass lying above the biologically active range, 0.2-10µm. Thus, PCU offers a substantial advantage over traditional bearing materials, not only in its low wear rate, but also in its osteolytic potential.