Micro- and nano-testing of calcium phosphate coatings produced by pulsed laser deposition.

Micro- and nano-testing methods have been explored to study the thin calcium phosphate coatings with high adhesive strength. The pulsed laser deposition (PLD) technique was utilised to produce calcium phosphate coatings on metal substrates, because this type of coatings exhibit much higher adhesive strength with substrates than conventional plasma-sprayed coatings. Due to the limitations of the conventional techniques to evaluate the mechanical properties of these thin coatings (1 microm thick), micro-scratch testing has been applied to evaluate the coating-to-substrate adhesion, and nano-indentation to determine the coating hardness and elastic modulus. The test results showed that the PLD produced amorphous and crystalline HA coatings are more ductile than titanium substrates, and the PLD coatings are not delaminated from the substrates by scratch. Also, the results showed that the crystalline HA coating is superior in internal cohesion to the amorphous one, even though the lower elastic modulus of amorphous coating could be more mechanically compatible with natural bone.

Incidence of bilateral proximal femoral fractures in a tertiary care center.

Over a 7-year period, a total of 545 osteoporotic fractures involving the proximal femur were treated at our institution. Twenty-nine patients sustained fractures of both hips, representing an overall incidence of bilateral hip fractures of approximately 5.5%. Of the 29 patients with bilateral hip fractures, adequate records and radiographs were avaialable for 28. There was a significant similarity between fracture patterns in the majority of bilateral hip fracture patients: 18 (64%) patients demonstrated similar fracture patterns on both sides. In these 18 patients, the average interval between fractures was approximately 1.7 years; in the remaining 10 patients, in whom the fractures were of dissimilar nature, the average interval between fractures was approximately 3.5 years. These findings suggest that at least 1 in 20 patients who sustain a fracture about the hip can expect to suffer a fracture involving the contralateral side. Moreover, the difference in the average interval for fractures of similar nature compared to fractures of dissimilar nature suggests the effects of physiologic age and the accordant changes in bone architecture play a larger role in predicting subsequent fracture pattern.

Effect of fabrication method and resin type on performance of tibial bearings.

Polyethylene has been used successfully for more than 30 years as an orthopedic bearing material. During this time, several polyethylene resins and fabrication methods have been used to produce bearings. Some bearings fail prematurely due to fatigue, which has been linked to oxidation and degradation of mechanical properties resulting from gamma sterilization in air. Fabrication method and/or resin have been hypothesized to govern whether oxidative degradation occurs in gamma-sterilized bearings. This study evaluates the effect of fabrication (machining/direct compression molding) and resin type on oxidation and the resulting mechanical properties for a large series of never-implanted bearings. While many molded bearings studied exhibit lower oxidation than machined bearings, fabrication method is not a significant predictor of oxidation. Resin type and shelf-age are found to be significant predictors of oxidation. Bearings fabricated from Himont 1900 exhibit lower oxidation than those from GUR 415/412 at comparable times after gamma in air. However, Himont 1900 bearings lose strength and elongation at lower oxidation levels than GUR 415/412 bearings. But since Himont 1900 oxidizes more slowly, Himont 1900 bearings retain mechanical properties for longer shelf times than comparable GUR 415/412 bearings. These effects are seen in retrievals as well.

Current sterilization and packaging methods for polyethylene.

Gamma sterilization in an air environment can induce oxidation in polyethylene. Oxidation can lead to polyethylene embrittlement, compromising mechanical integrity and clinical performance of polyethylene bearings. For these reasons, orthopaedic manufacturers have modified their methods of sterilizing and packaging polyethylene. Two alternative approaches have emerged: sterilization by non-radiation methods and sterilization by gamma irradiation in inert environments. The current study presents a prognosis for clinical performance of polyethylene sterilized with new methods, based on material property analyses (oxidation levels, mechanical properties, crosslink density) of never implanted and retrieved bearings. Data from bearings that were never implanted which were sterilized with the new methods and shelf aged as many as 3 years, show negligible oxidation, ductility above 400%, and ultimate tensile strength near 50 MPa, all exceeding specifications of the American Society for Testing and Materials. There are significant differences in crosslink density (swell ratio) depending on the sterilization method. Retrievals indicate that bearings sterilized with these new methods are performing well clinically and that the majority are not changing with time. The current study suggests that the shelf oxidation problem has been addressed by these new sterilization techniques and that clinical performance at short followup is acceptable. However, long-term clinical performance must be evaluated in the future.

An analysis of hylamer and polyethylene bearings from retrieved acetabular components.

Hylamer and conventional polyethylene acetabular liners of the same design, revised for a variety of reasons, were examined and compared to assess the performance of Hylamer as a bearing material. Clinical damage modes, linear wear rates, oxidation levels, and mechanical properties were measured. In both series, many liners were retrieved for dislocation. Wear/osteolysis was the most common reason for retrieval in the Hylamer series, while none of the conventional polyethylene liners were retrieved for this reason. Nearly all liners exhibited abrasion, burnishing, scratching, and creep. The Hylamer liners had more cracking, delamination, and pitting. The Hylamer liners had an average linear wear rate of 0.32 mm/year, while the conventional polyethylene liners had an average wear rate of 0.20 mm/year. Due to sample size, no statistical difference in wear rate was noted between the two groups. In general, both the Hylamer and conventional polyethylene showed oxidation peaks subsurface, resulting from their exposure to gamma radiation in air. Liners with elevated oxidation had decreased ultimate tensile strength, elongation, and toughness. For given oxidation levels, the corresponding mechanical properties of Hylamer appeared lower than those of conventional polyethylene. The ultimate tensile strength values ranged from 14 to 33 MPa for Hylamer and 19 to 32 MPa for conventional polyethylene. Elongation ranges were 19% to 350% (Hylamer) and 80% to 375% (conventional). The Hylamer retrievals in this study gave initial indications of performance; Hylamer appeared to behave similarly, but not superiorly, to conventional polyethylene, in the early functional period with respect to clinical wear and clinical performance. Both Hylamer and conventional polyethylene liners were degraded by gamma sterilization in air, with Hylamer liners demonstrating greater property changes.

Physicochemical properties of calcium phosphate coatings produced by pulsed laser deposition at different water vapour pressures.

Calcium phosphate coatings were produced by pulsed laser deposition from targets of non-stoichiometric hydroxyapatite (Ca/P = 1.70) at a substrate temperature of 485 degrees C and different processing pressures of water vapour: 0.15, 0.30, 0.45, 0.60 and 0.80 mbar. The physicochemical properties of these coatings were studied using Fourier-transform IR spectroscopy (FT-IR) and energy dispersive X-ray analysis (EDX). A minimum pressure of water vapour was necessary in order to obtain a crystalline coating, as deduced from the FT-IR spectroscopy of these coatings. This analysis also revealed that when the deposition pressure of water vapour was further increased, the coatings were less crystalline and the content of hydroxyl groups, the carbonate substitution for phosphate, and the Ca/P ratio, as measured by EDX, were lower. These effects can be explained by a combined substitution of carbonate and HPO4(2-) for phosphate, being predominant the carbonate substitution at low pressures and the HPO4(2-) substitution at high pressures.

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.

The value of postmortem retrievals in the analysis of long-term, well-functioning cemented femoral stems.

Multiple sections from long-term, low-friction bilateral Charnley prostheses harvested from two patients who died 20 and 22 years after the primary implantation were studied. All sections showed generally sound mechanical integrity at both the cement-bone and cement-metal interfaces, in spite of localized evidence of cement fracture and debonding. The host tissues showed no clear evidence of an adverse biologic response toward the implant. These findings aided in the delineation of the sequence of biologic and mechanical events that lead to prosthesis failure. They suggest that if the apparently unavoidable mechanical deterioration of cemented implants can be limited by good fixation between the host and prosthesis, then disastrous biologic events, such as osteolysis, may be avoided, and long-term function, preserved.

Shelf life and in vivo duration. Impacts on performance of tibial bearings.

Polyethylene has been used for more than 30 years as an orthopaedic bearing material; however, recently concern has been focused on the early failure of some polyethylene bearings. The damage seen in some bearings has been linked to gamma radiation sterilization performed in an air environment. Gamma sterilization in air has been documented to cause an increase in oxidation and degradation of mechanical properties that continue with time. However, not all retrieved bearings that are gamma sterilized in air exhibit the elevated oxidation and mechanical property degradation that lead to early component failure. Bearings that are gamma sterilized in air oxidize while sitting in inventory before implantation. Shelf oxidation rate was estimated based on analysis of a series of never implanted tibial bearings. This shelf oxidation rate allowed estimation of in vivo oxidation for retrieved tibial bearings of known sterilization date. Bearings with less than 1 year of shelf life after gamma sterilization in air had lower in vivo oxidation and better in vivo performance than did those with longer shelf life before implantation. Shelf time before implantation appears to be a significant factor in the success or failure of bearings that are gamma sterilized in air.

Hydroxyapatite coatings: a comparative study between plasma-spray and pulsed laser deposition techniques.

A comparative study between hydroxyapatite coatings produced by two different techniques, plasma spray (PS) and pulsed-laser deposition (PLD) was carried out. Plasma spray is currently commercially used for coating dental and orthopaedical implant devices, and pulsed-laser deposition (or laser-ablation deposition) gave good results in the field of high critical temperature superconductive thin films, and is being applied to produce calcium phosphate coatings for biomedical purposes. X-ray diffraction was used to control the crystallinity of the coatings, scanning electron microscopy for the surface and cross-sectional morphology, and the pull test to determine the tensile strength of the coatings. This study reveals that the pulsed-laser deposition technique appears to be a very good candidate to replace the plasma spray in many biomedical applications, because it overcomes most of the drawbacks of the plasma spray.

Structural analysis of calcium phosphate coatings produced by pulsed laser deposition at different water-vapour pressures.

Calcium phosphate coatings have been produced by pulsed laser deposition (PLD) at different water-vapour pressures. Rietveld refinement of X-ray diffraction (XRD) data allows us to determine that the structure of these coatings is apatitic with carbonate substitution for phosphate. The carbonate substitution decreases when the chamber pressure is raised, a fact that has been corroborated by Fourier transform-infrared (FT-IR) spectroscopy. Carbonate concentrations between 5 and 17 wt% have been calculated for the crystalline samples. Amorphous coatings are produced at the lowest and highest pressures due to the high carbonate concentration in the first case, and possibly to another type of substitution (Mg(2+), HPO(2-)4, P2O(4-)7) or the inherent kinetics of the PLD process, in the second case.

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 component's preimplantation shelf life.

Impact of gamma sterilization on clinical performance of polyethylene in the knee.

Damage and rapid wear of the ultrahigh-molecular-weight polyethylene bearings of knee components continue to be major sources of failure of knee prostheses. Despite considerable research into the roles of design, polyethylene thickness and quality, and component alignment, the source of the rapid wear failures has remained a mystery. This study documents elevated oxidation resulting from the use of gamma sterilization in air, the most common sterilization technique used by the orthopaedic implant industry. This oxidation reduces static strength and elongation properties and significantly decreases the resistance of polyethylene bearings to fatigue, a frequent source of early damage of many of these devices.

Tibiotalar contact area. Contribution of posterior malleolus and deltoid ligament.

Sixteen fresh ankle specimens were tested under physiologic loads to evaluate the effect on the tibiotalar contact area of increasing-size posterior malleolar fracture fragments and disruption of the deltoid ligament. The tibiotalar joint was maintained in a neutral position, and contact areas were recorded on pressure sensitive film. Posterior malleolar fracture fragments of 25%, 33%, and 50% as visualized on lateral radiographs were created. The deltoid ligament was sectioned after the final fracture fragment was made. There was a corresponding decrease of 4%, 13%, and 22% in tibiotalar contact area with the increasingly larger fracture fragments. The final disruption of the deltoid ligament did not alter the contact area. Statistical analyses using Student's t-test showed a statistically significant decrease in tibiotalar contact area in the samples with a fracture fragment of 33% and 50% involvement of the joint as compared with the control samples. Transection of the deltoid ligament produced no statistically significant further change in contact area. Displaced posterior malleolus fractures produce a significant decrease in contact area with 33% or greater involvement of the joint, which may predispose the tibiotalar joint to degenerative changes that should be lessened by anatomic reduction and internal fixation. Disruption of the deltoid ligament does not appear to alter contact area further, supporting the concept of repair as optional.

The Otto Aufranc Award. Impact of gamma sterilization on clinical performance of polyethylene in the hip.

Despite studies to determine their causes, significant variations in polyethylene acetabular component wear rates, radial cracking of component rims, and occasional delamination cannot be explained. A subsurface white band frequently occurs in such damaged components. These damaged components often are gamma sterilized. To date, the origin of the band and its effect on polyethylene chemical and mechanical properties, and hence, clinical performance, have not been confirmed, and correlations between radiation sterilization and clinical wear have not been made. By developing techniques for polyethylene retrieval testing and rating, chemical analysis, and mechanical analysis, this research has determined that gamma sterilization in air alters the chemical and mechanical properties of polyethylene over time, resulting in high subsurface oxidation, reduced ductility, and reduced strength. Gamma sterilization-induced oxidation is found to be most severe in the subsurface region of components, and coincides with zones of significantly reduced strength and ductility. This chemical and mechanical property degradation is time dependent and is not typically visible until after 3 years' postirradiation. The presence of the subsurface white band significantly correlates with clinical cracking and delamination observed in retrieved components. Wear of the retrieved components often is observed to have progressed into this heavily oxidized, weakened, and embrittled zone. A method for accelerated aging shows that irradiating in air causes oxidation damage in polyethylene components that is not seen with other sterilization methods. Modifications of gamma sterilization techniques to minimize this damage are discussed.

The tradeoffs associated with modular hip prostheses.

In an effort to gain greater insight into the tradeoffs associated with modular hip prostheses, 2 approaches were taken. A questionnaire was sent to each of the orthopaedic implant manufacturing companies asking specific questions regarding modular components, and a series of retrieved prostheses, both modular and nonmodular, were examined to determine the potential sources of problems associated with modular connections. The respondents to the questionnaire generally agreed that it was more expensive to produce modular prostheses due to the required tolerances at the modular connections, and that the increased flexibility provided by the modularity was important to surgical outcome. There was less consensus on whether inventories were reduced and little data to support any improvement in surgical outcome caused by modularity. The most frequent problems associated with modular connections were fretting and corrosion. Easily observable significant fretting occurred in 4% of 701 head/neck tapers. Corrosion was observed in > 30% of the mixed-alloy head/stem combinations, in < 10% of all-titanium-alloy modular components, and in < 6% of all-cobalt-alloy devices. In 1 series of retrieved modular femoral components (15 titanium alloy and 15 cobalt alloy) with both sets having approximately the same duration of implantation, 7% of the all-cobalt-alloy components had corrosion, whereas 33% of the mixed-alloy components had corrosion.

Reconstructive amputation after grade IIIC open tibial fracture. One method of preserving residual limb length.

A high percentage of patients with grade IIIC open tibial fractures eventually undergo amputation. Maintaining an adequate residual limb length is advantageous with regard to biomechanics, energy expenditure, and prosthetic fitting. This case report presents new considerations for maintaining residual limb length in the presence of comminuted proximal tibial fractures. These considerations include (a) using an autogenous fibular strut graft for stabilizing the reconstructed residual limb and (b) determining the level of amputation based on soft-tissue integrity rather than on fracture level. We present one technique for preserving an adequate residual limb length in the face of significant proximal tibia comminution.

A comparison of contact pressures in tibial and patellar total knee components before and after service in vivo.

Laboratory testing of total knee components indicates that many designs produce contact stresses that exceed the yield strength of ultra-high molecular weight polyethylenes (UHMWPEs). It is often assumed that the polyethylene component will creep and wear to become more conforming over time, thus reducing these stresses. To test this theory, retrieved polyethylene tibial and patellar components, which showed signs of increased contact area through in vivo deformation, were tested for contact stress against matching components using Fuji Prescale pressure-sensitive film. The results showed an inverse relationship between initial conformity and in vivo changes in contact stress. More conforming devices showed little or no change in contact stress, and less conforming components showed small decreases in contact stress as a result of creep and wear. Even with these changes, however, the contact stresses for nonconforming designs remained well above those for the more conforming devices as well as the uniaxial yield strength of UHMWPE.

The correlation between fusion defects and damage in tibial polyethylene bearings.

Recent reports of fatigue failures of polyethylene tibial and patellar components have led to investigation of the role of design and material properties in these failures. Earlier investigations, concluding that high contact stress designs suffered greater damage in service, could not account for some of the fatigue failures. The current study hypothesizes that this failure is related to variations in the material properties of the polyethylene due to incomplete consolidation of the powder during manufacture, resulting in fusion defects. Retrieved polyethylene components and samples of polyethylene stock were examined to gain insight into the relationship between fusion defects, component failure, material forming processes, and powder grade. Statistically significant correlations (p < 0.05) were observed between the extent of defects and cracking, delamination, total wear damage, and duration in vivo. These correlations indicate that components manufactured from material with fusion defects may be less resistant to fatigue than components formed of fully consolidated material.