Failure of Emperion modular femoral stem with implant analysis.

Modularity in total hip arthroplasty provides multiple benefits to the surgeon in restoring the appropriate alignment and position to a previously damaged hip joint. The vast majority of modern implants incorporate modularity into their design with some implants having multiple modular interfaces. There is the potential for failure at modular junctions because of fretting and crevice corrosion in combination with mechanical loading. This case report details the failure of an Emperion (Smith and Nephew, Memphis, TN) femoral stem in a 67-year-old male patient 6 years after total hip replacement. Analysis of the implant revealed mechanically assisted crevice corrosion that likely accelerated fatigue crack initiation in the hip stem. The benefits of modularity come with the potential drawback of a combination of fretting and crevice corrosion at the modular junction, which may accelerate fatigue, crack initiation and ultimately reduce the hip longevity.

The use of polyurethane materials in the surgery of the spine: a review.

BACKGROUND CONTEXT: The spine contains intervertebral discs and the interspinous and longitudinal ligaments. These structures are elastomeric or viscoelastic in their mechanical properties and serve to allow and control the movement of the bony elements of the spine. The use of metallic or hard polymeric devices to replace the intervertebral discs and the creation of fusion masses to replace discs and/or vertebral bodies changes the load transfer characteristics of the spine and the range of motion of segments of the spine. PURPOSE: The purpose of the study was to survey the literature, regulatory information available on the Web, and industry-reported device development found on the Web to ascertain the usage and outcomes of the use of polyurethane polymers in the design and clinical use of devices for spine surgery. STUDY DESIGN/SETTING: A systematic review of the available information from all sources concerning the subject materials' usage in spinal devices was conducted. METHODS: A search of the peer-reviewed literature combining spinal surgery with polyurethane or specific types and trade names of medical polyurethanes was performed. Additionally, information available on the Food and Drug Administration Web site and for corporate Web sites was reviewed in an attempt to identify pertinent information. RESULTS: The review captured devices that are in testing or have entered clinical practice that use elastomeric polyurethane polymers as disc replacements, dynamic stabilization of spinal movement, or motion limitation to relieve nerve root compression and pain and as complete a listing as possible of such devices that have been designed or tested but appear to no longer be pursued. This review summarizes the available information about the uses to which polyurethanes have been tested or are being used in spinal surgery. CONCLUSIONS: The use of polyurethanes in medicine has expanded as modifications to the stability of the polymers in the physiological environment have been improved. The potential for the use of elastomeric materials to more closely match the mechanical properties of the structures being replaced and to maintain motion between spinal segments appears to hold promise. The published results from the use of the devices that are discussed show early success with these applications of elastomeric materials.

Contributions of stress corrosion and cyclic fatigue to subcritical crack growth in a dental glass-ceramic.

OBJECTIVE: The objective of this study was to test the following hypotheses: (1) both cyclic degradation and stress-corrosion mechanisms result in subcritical crack growth (SCG) in a fluorapatite glass-ceramic (IPS e.max ZirPress, Ivoclar-Vivadent) and (2) there is an interactive effect of stress corrosion and cyclic fatigue to accelerate subcritical crack growth. METHODS: Rectangular beam specimens were fabricated using the lost-wax process. Two groups of specimens (N=30/group) with polished (15µm) or air-abraded surface were tested under rapid monotonic loading. Additional polished specimens were subjected to cyclic loading at two frequencies, 2Hz (N=44) and 10Hz (N=36), and at various stress amplitudes. All tests were performed using a fully articulated four-point flexure fixture in deionized water at 37°C. The SCG parameters were determined using the ratio of inert strength Weibull modulus to lifetime Weibull modulus. A general log-linear model was fit to the fatigue lifetime data including time to failure, frequency, peak stress, and the product of frequency and logarithm of stress in ALTA PRO software. RESULTS: SCG parameters determined were n=21.7 and A=4.99×10(-5) for 2Hz, and n=19.1 and A=7.39×10(-6) for 10Hz. After fitting the general log-linear model to cyclic fatigue data, the coefficients of the frequency term (α1), the stress term (α2), and the interaction term (α3) had estimates and 95% confidence intervals of α1=-3.16 (-15.1, 6.30), α2=-21.2 (-34.9, -9.73), and α3=0.820 (-1.59, 4.02). Only α2 was significantly different from zero. SIGNIFICANCE: (1) Cyclic fatigue does not have a significant effect on SCG in the fluorapatite glass-ceramic evaluated and (2) there was no interactive effect between cyclic degradation and stress corrosion for this material.

The use of compliant layer prosthetic components in orthopedic joint repair and replacement: a review.

The surgical repair or treatment of degenerative joint disease has traditionally involved the substitution of synthetic materials for one or both surfaces of the joint. Engineering thermoplastics, metals, and ceramics have either been widely accepted or experimentally evaluated for use as bearing surfaces in these prostheses. When engineering thermoplastics are used, the opposing surface is a metal or a ceramic, but metal-on-metal, metal-on-ceramic, and ceramic-on-ceramic have also been used or tested. Researchers have sought the opportunity to utilize materials with compressive mechanical properties more closely matching those of the natural articular cartilage. This review discusses the theory, testing, and application of elastomers for one bearing component of articular joint prostheses.

Fatigue loading and R-curve behavior of a dental glass-ceramic with multiple flaw distributions.

OBJECTIVES: To determine the effects of surface finish and mechanical loading on the rising toughness curve (R-curve) behavior of a fluorapatite glass-ceramic (IPS e.max ZirPress) and to determine a statistical model for fitting fatigue lifetime data with multiple flaw distributions. MATERIALS AND METHODS: Rectangular beam specimens were fabricated by pressing. Two groups of specimens (n=30) with polished (15 µm) or air abraded surface were tested under rapid monotonic loading in oil. Additional polished specimens were subjected to cyclic loading at 2 Hz (n=44) and 10 Hz (n=36). All fatigue tests were performed using a fully articulated four-point flexure fixture in 37°C water. Fractography was used to determine the critical flaw size and estimate fracture toughness. To prove the presence of R-curve behavior, non-linear regression was used. Forward stepwise regression was performed to determine the effects on fracture toughness of different variables, such as initial flaw type, critical flaw size, critical flaw eccentricity, cycling frequency, peak load, and number of cycles. Fatigue lifetime data were fit to an exclusive flaw model. RESULTS: There was an increase in fracture toughness values with increasing critical flaw size for both loading methods (rapid monotonic loading and fatigue). The values for the fracture toughness ranged from 0.75 to 1.1 MPam(1/2) reaching a plateau at different critical flaw sizes based on loading method. SIGNIFICANCE: Cyclic loading had a significant effect on the R-curve behavior. The fatigue lifetime distribution was dependent on the flaw distribution, and it fit well to an exclusive flaw model.

Evaluation of the wear performance of a polycarbonate-urethane acetabular component in a hip joint simulator and comparison with UHMWPE and cross-linked UHMWPE.

Acetabular hip joint components manufactured from gamma-sterilized ultra high molecular weight polyethylene (UHMWPE), gamma cross-linked UHMWPE, or polycarbonate-urethane (PCU) polymers were evaluated in a hip joint simulator, using cobalt alloy femoral components, for at least 5 million cycles. The volume of material losses due to wear was calculated for each type of sample, based upon mass loss measurements, every 500,000 cycles. The loss of material for the conventional UHMWPE was much higher than for the cross-linked UHMWPE, showing about a 70% reduction in wear due to cross-linking. The material loss for the PCU samples appears to have been at least 24% lower than for the cross-linked UHMWPE. Based upon these results, the PCU material seems to have potential for use as an alternative bearing material to UHMWPE for total hip replacement surgeries.

The effect of serum protein concentration on wear rates in a hip simulator.

Ultra high molecular weight polyethylene cups, 22 mm in diameter, were aged for 5 years in the normal laboratory environment. Half of the samples had been processed by the standard radiation sterilization techniques, while the remainder had been cross-linked by a technique involving higher radiation doses and controlled temperature at the time of irradiation. The samples had been tested in a hip simulator for 5,000,000 cycles using a lubricant that had been diluted 1:1 with deionized water. Once that testing was completed, further testing was conducted using lubricant with greater and lesser serum protein concentrations, and the results compared with those that had already been recorded. Comparison of the wear rates within the study as well as to published data concerning the effect of serum concentration showed results that were consistent with assumed differences in lubrication ability at different concentrations. The results of other published studies were found to be inconsistent with each other and different from some of the results of this study. There is shown to be a need for carefully controlled and conducted studies to agree, if possible, on the importance of the serum concentration and the appropriate parameters to be used in testing, as well as variations that may be necessary with different bearing material characteristics.

Biocompatibility of dental materials.

With the long history of use of many materials in dental surgery, biocompatibility concerns are not as great a concern as other issues, such as long-term degradation, mechanical strength problems, and prevention of secondary caries. It is important, however, not to forget that the potential exists for adverse tissue responses to synthetic materials used in repair, augmentation, and repair of natural tissue structures. As new materials and repair techniques become available and the sophistication of cell-level and subcellular response evaluations increases, the concerns to be addressed and the methods to be used may change. The advent of tissue-engineered medical products may mean that new questions must be addressed.

Effects of spaceflight on the attachment of tendons to bone in the hindlimb of the pregnant rat.

The objective of this study was to determine the effects of spaceflight on the structure of the tendon-bone junction (TBJ). Pregnant rats either flew in the space shuttle Atlantis (flight group; F) or were exposed to simulated launch and landing protocols (synchronous control group; SC) during days 9-19 of pregnancy. Following birth of their pups, maternal hindlimbs were studied using scanning electron and light microscopic histomophometric techniques. The tibial and calcaneal tuberosities, the fibular head, and the tibia-fibula junction were studied. Myofiber density and cross-sectional area of the quadratus femoris and soleus muscles and diameters of the calcaneal and patellar tendons were also evaluated. Cortical erosion was significantly greater at the tibial tuberosity and the fibular head in F animals compared to SC animals (P < 0.001). Sharpey fiber density was significantly less at the tibial tuberosity and fibular head in F animals compared to SC animals (P < 0.001). The myofiber area of both the soleus and quadratus femoris muscles and the diameters of both calcaneal and patellar tendons were significantly less in F compared to SC rats (P < 0.05). Our data illustrate that the TBJ morphology is affected by spaceflight at the attachment sites of the soleus and quadratus femoris muscles in pregnant animals, which could adversely affect their physical properties. These atrophic TBJ changes could have resulted from atrophy of the adjacent muscles and their tendons. Atrophic changes in the structure of the TBJ could predispose an animal to injury following spaceflight, when normal gravity conditions are reestablished.

Wear evaluation of cobalt-chromium alloy for use in a metal-on-metal hip prosthesis.

Wear of the polyethylene in total joint prostheses has been a source of morbidity and early device failure, which has been extensively reported in the last 20 years. Although research continues to attempt to reduce the wear of polyethylene joint-bearing surfaces by modifications in polymer processing, there is a renewed interest in the use of metal-on-metal bearing couples for hip prostheses. Wear testing of total hip replacement systems involving the couple of metal or ceramic heads on polymeric acetabular components has been performed and reported, but, until recently, there has been little data published for pin-on-disk or hip-simulator wear studies involving the combination of a metallic femoral head component with an acetabular cup composed of the same or a dissimilar metal. This study investigated the in vitro wear resistance of two cobalt/chromium/molybdenum alloys, which differed primarily in the carbon content, as potential alloys for use in a metal-on-metal hip-bearing couple. The results of pin-on-disk testing showed that the alloy with the higher (0.25%) carbon content was more wear resistant, and this alloy was therefore chosen for testing in a hip-simulator system, which modeled the loads and motions that might be exerted clinically. Comparison of the results of metal-on-polyethylene samples to metal-on-metal samples showed that the volumetric wear of the metal-on-polyethylene bearing couple after 5,000,000 cycles was 110-180 times that for the metal-bearing couple. Polyethylene and metal particles retrieved from either the lubricant for pin-on-disk testing or hip simulator testing were characterized and compared with particles retrieved from periprosthetic tissues by other researchers, and found to be similar. Based upon the results of this study, metal-on-metal hip prostheses manufactured from the high carbon cobalt/chromium alloy that was investigated hold sufficient promise to justify human clinical trials.