Michael B. Mayor

Basic epidemiology of fractures of the upper and lower limb among Americans over 65 years of age

&NA; Current knowledge regarding the basic epidemiology of fractures is largely limited to a few fracture sites, notably those of the hip and distal forearm. To clarify the patterns of incidence of limb fractures in the elderly, we used data from a 5% sample of the U.S. Medicare population over age 65 years during the years 1986‐1990. We identified incident fractures of the proximal humerus, other parts of the humerus, proximal radius/ulna, shaft of the radius/ulna, distal radius/ulna, pelvis, hip, other parts of the femur, patella, ankle, and other parts of the tibia/fibula from diagnoses and procedures coded on claims for inpatient services, outpatient facility use, and physician services. We used Poisson regression to investigate the relation between demographic factors and fracture risk at these sites. Fractures at the hip were the most common, accounting for 38% of the fractures identified. The proximal humerus, distal radius/ulna, and ankle also were common fracture sites. A pattern of rapidly rising rates with age was seen for fractures of the pelvis, hip, and other parts of the femur among women. Fractures distal to the elbow or knee, however, had, at most, modest increases in incidence with age over 65 years. For each of the fractures studied, women had higher rates than men of the same race, and whites generally had higher rates than blacks of the same gender. Gender‐related differences in risk were larger among whites than among blacks, and racial differences in risk were more marked among women than among men. (Epidemiology 1996;7:612‐618)

Analysis of the failure of 122 polyethylene inserts from uncemented tibial knee components.

The extent of wear of retrieved, polyethylene tibial components appears to be related to design. To test this observation, 122 tibial inserts were graded for wear, and new components of several designs were tested for contact stress using Fuji film. Finite element analysis provided insight into subsurface stresses. Significant wear was seen in 61.5% of the tibial inserts examined. The presence of unconsolidated polymer powder was seen in 44% of the tibial inserts and was found to be statistically correlated with severe wear of the articulating surface. Contact stress in several noncongruent designs was found to exceed the yield strength of polyethylene. There was a positive correlation between the intensity of wear and the level of contact stress, with noncongruent designs having greater wear than fully congruent geometries. In the non-congruent designs, the thinner polyethylene components showed greater wear than thicker polyethylene inserts of the same design.

Rim cracking of the cross-linked longevity polyethylene acetabular liner after total hip arthroplasty.

BACKGROUND Studies have suggested that cross-linked polyethylene bearings reduce wear rates from 40% to 100% compared with conventional polyethylene. However, the reduced mechanical properties of highly cross-linked polyethylene have the potential to be a limiting factor in device performance. We reviewed a series of retrieved acetabular liners with a fracture of the superior rim to assess the factors that played a role in their failure. METHODS Four Longevity acetabular bearings, which had been retrieved from two patients after seven to twenty-seven months in vivo, were visually examined for clinical damage, were assessed with use of Fourier transform infrared spectroscopy to determine the level of oxidation, and were analyzed for mechanical properties and fracture surface characterization. Control data were obtained from never-implanted devices and from global reference ultrahigh molecular weight polyethylene bar stock as an industry calibration material. RESULTS All four retrieved liners demonstrated articular surface wear modes, which in most cases were rated as moderate, and none were rated as severe. All showed cracking or rim failure of the liner at the superior aspect along the groove in the polyethylene that engages the locking ring of the shell. The retrieved liners had no measurable oxidation, and the mechanical properties were comparable with those of never-implanted material. CONCLUSIONS There was no notable in vivo degradation of the retrieved liners. Important factors related to failure appear to be thin polyethylene at the cup rim, relatively vertical cup alignment, and the material properties of the highly cross-linked polyethylene that are decreased relative to conventional polyethylene. The critical dimension with respect to rim failure in modular liners appears to be the minimum thickness at the equatorial region.

Corrosion between the components of modular femoral hip prostheses

We studied the tapered interface between the head and the neck of 139 modular femoral components of hip prostheses which had been removed for a variety of reasons. In 91 the same alloy had been used for the head and the stem; none of them showed evidence of corrosion. In contrast, there was definite corrosion in 25 of the 48 prostheses in which the stem was of titanium alloy and the head of cobalt-chrome. This corrosion was time-dependent: no specimens were corroded after less than nine months in the body, but all which had been in place for more than 40 months were damaged. We discuss the factors which may influence the rate of these changes and present evidence that they were due to galvanically-accelerated crevice corrosion, which was undetected in previous laboratory testing of this type of prosthesis.

Corrosion at the interface of cobalt-alloy heads on titanium-alloy stems.

The combination of a cobalt-alloy head on a titanium-alloy femoral hip stem is widely accepted for press-fit and biologic fixation applications. Examination of 30 components retrieved at periods of 0.5 to 66.9 months for histologic examination of tissue ingrowth revealed that 56.6% of the tapered connections between head and stem showed evidence of crevice corrosion leading to concerns of metal ion release and the potential failure of head to stem fixation.

Overview of polyethylene as a bearing material: comparison of sterilization methods.

Polyethylene has been used for more than 30 years as an orthopaedic bearing material; however, there has been recent concern regarding the early failure of a small percentage of the polyethylene bearings. The damage seen in some retrieved polyethylene components has been linked to gamma radiation sterilization in air, which was widely used by the industry for years. Gamma radiation in air has been documented to cause an increase in oxidation and degradation of mechanical properties with time. The degradation of polyethylene initiated by gamma sterilization in air has led the orthopaedic industry toward alternative sterilization methods, including gamma radiation in an inert gas or vacuum environment, ethylene oxide gas sterilization, and gas plasma sterilization. For many of these alternative techniques, little clinical performance data exist. This study is a comparative evaluation of sterilization methods using the same analytic techniques that have been used to document the effects of gamma sterilization in air on polyethylene. Fourier transform infrared spectroscopy, electron spin resonance, and uniaxial tensile testing are used to compare, respectively, the oxidation levels, free radical concentration, and mechanical properties of material sterilized by each method. The polyethylene is evaluated before sterilization, poststerilization, and postartificial aging. All examined alternative sterilization methods, when compared with gamma sterilization in air, caused less material degradation during a components preimplantation shelf life.

Macroscopic and microscopic evidence of prosthetic fixation with porous-coated materials.

The host response to porous-coated prostheses appears favorable; there is little evidence of any adverse tissue response or significant osteoclastic activity except in grossly loose specimens. While the nature of retrieval specimens makes any statistical correlation problematic, some generalizations can be made. Femoral hip prostheses are most likely to present bone ingrowth along the lateral quadrant of their porous coating. The frequency of bone ingrowth of femoral components was nearly twice that of acetabular devices. Pore size, geometry, and porous-coating composition did not appear to influence the appearance of bone and fibrous tissue ingrowth. Direct bonding of bone to the uncoated portion of the prosthesis was rarely seen and occurred only in closest proximity to the porous-coated regions. Indications of pain and looseness are evidence that fibrous tissue ingrowth alone is not always sufficient to ensure stability. Additionally, some bone-ingrown prostheses were retrieved because of pain, which leads to the conclusion that local bone ingrowth cannot ensure a general freedom from pain, especially with partially coated prostheses. Bone and fibrous tissue response to the porous coatings generally consists of interdigitation, while the response to uncoated regions is fibrous tissue encapsulation. Burnishing the distal tips of many of the partially coated femoral prostheses is an indication of relative motion in that region, which may be a potential source of pain.

Mechanisms of failure of modular prostheses.

The expectations of wear and longevity of total hip components are based in large part on Charnleys early work. The evolution of the total hip from the one-piece, all-polyethylene acetabular component and fixed-head femoral component to the myriad of parts that comprise many of todays total hip designs has brought with it an array of potential mechanisms for failure that were not present in the earlier design. The risk/benefit ratio of these new designs may need to be reevaluated based on the additional mechanisms for failure that they provide. One hundred eleven acetabular hip prostheses and 139 femoral prostheses, all of modular configuration, retrieved by surgeons in the field, and sent for histologic examination, were analyzed for this study. A number of component characteristics were found to be correlated to early failure. These included acetabular designs with thin polyethylene bearings, poor fixation of the polyethylene to the metal shell, and geometries that permitted a moment to be applied to the bearing insert, tending to cause it to rotate in the metal shell. Modular femoral components were observed to be susceptible to corrosion, with titanium-alloy stems mated to cast cobalt-alloy heads at greatest risk attributable to a galvanic effect. All modular connections of femoral and acetabular components are at risk for disassociation and fretting; therefore, clever design and precision machining are necessary to produce prostheses in which the benefits of modularity exceed the risks.

Evaluation of Oxidation and Fatigue Damage of Retrieved Crossfire Polyethylene Acetabular Cups

BACKGROUND Crossfire cross-linked polyethylene is produced differently from other cross-linked polyethylene materials; a below-melt-temperature annealing process is used with the goal of avoiding compromised mechanical properties. The present study was performed to evaluate retrieved Crossfire acetabular cups to determine whether they had oxidized and to what extent oxidation might have influenced their clinical performance. METHODS Eleven acetabular cups were received at retrieval and a twelfth acetabular cup was received two years post-retrieval over a period of four years. None were retrieved because of polyethylene wear or fatigue. The cups had been in vivo from 0.1 to 5.3 years. Each was examined visually, clinical fatigue damage was rated, and oxidation was measured with use of Fourier transform infrared spectroscopy. RESULTS The cups exhibited oxidation that varied with its location on the cup: the oxidation value was generally low on the articular surface but more than an order of magnitude higher value on the rim. Maximum rim oxidation correlated significantly with the time in vivo (Spearman rho = 0.734, p = 0.010). Oxidation was identified visually by a white band in thin sections on the rim of seven of the cups and on the articular surface of one of these seven cups. Six of the seven cups also exhibited clinical fatigue damage. Eight of the twelve cups exhibited evidence of impingement or dislocation. CONCLUSIONS Acetabular cups made of Crossfire polyethylene oxidized to a measurable degree. The oxidation-related reduction of polyethylene mechanical properties was sufficient to allow the fatigue damage seen in these retrieved cups.

The Impact of Sterilization Method on Wear in Knee Arthroplasty

Sterilization by gamma irradiation in air has been shown to have the potential to accelerate the oxidation of polyethylene components resulting in reduced mechanical properties. In the hip, it has been reported that the occurrence of delamination and cracking in retrieved bearings is significantly different when comparing components sterilized with gamma irradiation in air with components sterilized with ethylene oxide. Using a collection of 1635 retrieved polyethylene knee bearings, this study pursues a similar comparison of sterilization method with clinical wear in the knee. It confirms that retrieved polyethylene knee components that were gamma irradiated in air have a high incidence of delamination and cracking, leading at times to complete wear through of the bearing. Knee components sterilized with ethylene oxide showed no evidence of fatigue damage even after in vivo durations in excess of 15 years.