Wear testing of crosslinked polyethylene: wear rate variability and microbial contamination.

The wear performance of two types of crosslinked polyethylene (Marathon™ and XLK™, DePuy Synthes Inc., Warsaw, IN) was evaluated in a pin-on-disc wear tester, a hip wear simulator, and a knee wear simulator. Sodium azide was used as the microbial inhibitor in the calf serum-based lubricant. In the pin-on-disc wear tester, the Marathon wear rate of 5.33±0.54mm(3)/Mc was significantly lower (p=0.002) than the wear rate of 6.43±0.60mm(3)/Mc for XLK. Inversely, the Marathon wear rate of 15.07±1.03mm(3)/Mc from the hip wear simulator was 2.2-times greater than the XLK wear rate of 6.71±1.03mm(3)/Mc from the knee wear simulator. Differences in implant design, conformity, GUR type, and kinematic test conditions were suggested to account for the difference between the wear rates generated in the different types of wear testing apparati. In all wear tests, sodium azide was ineffective at inhibiting microbial growth in the lubricant. Eight different organisms were identified in the lubricant samples from the wear tests, which suggested the necessity of using an alternative, more effective microbial inhibitor. Careful sample preparation and thorough cleaning has shown to improve the consistency of the wear results. The wear rates generated in the hip and knee wear simulators closely reflected the wear behaviour of Marathon and XLK reported in published data that were tested under similar conditions.

Hip, knee, and ankle kinematics of high range of motion activities of daily living.

Treatment of joint disease that results in limited flexion is often rejected by patients in non-Western cultures whose activities of daily living require a higher range of motion at the hip, knee, or ankle. However, limited information is available about the joint kinematics required for high range of motion activities, such as squatting, kneeling, and sitting cross-legged, making it difficult to design prosthetic implants that will meet the needs of these populations. Therefore, the objective of this work was to generate three-dimensional kinematics at the hip, knee, and ankle joints of Indian subjects while performing activities of daily living. Thirty healthy Indian subjects (average age: 48.2 +/- 7.6 years) were asked to perform six trials of the following activities: squatting, kneeling, and sitting cross-legged. Floating axis angles were calculated at the joints using the kinematic data collected by an electromagnetic motion tracking device with receivers located on the subject's foot, shank, thigh, and sacrum. A mean maximum flexion of 157 degrees +/- 6 degrees at the knee joint was required for squatting with heels up. Mean maximum hip flexion angles reached up to 95 degrees +/- 27 degrees for squatting with heels flat. The high standard deviation associated with this activity underscored the large range in maximum hip flexion angles required by different subjects. Mean ankle range of flexion reached 58 degrees +/- 14 degrees for the sitting cross-legged activity. The ranges of motion required to perform the activities studied are greater than that provided by most currently available joint prostheses, demonstrating the need for high range of motion implant design.

Impact loading of articular cartilage during transplantation of osteochondral autograft.

Surgical reconstruction of articular surfaces by transplantation of osteochondral autografts has shown considerable promise in the treatment of focal articular lesions. During mosaicplasty, each cylindrical osteochondral graft is centred over the recipient hole and delivered by impacting the articular surface. Impact loading of articular cartilage has been associated with structural damage, loss of the viability of chondrocytes and subsequent degeneration of the articular cartilage. We have examined the relationship between single-impact loading and chondrocyte death for the specific confined-compression boundary conditions of mosaicplasty and the effect of repetitive impact loading which occurs during implantation of the graft on the resulting viability of the chondrocytes. Fresh bovine and porcine femoral condyles were used in this experiment. The percentage of chondrocyte death was found to vary logarithmically with single-impact energy and was predicted more strongly by the mean force of the impact rather than by the number of impacts required during placement of the graft. The significance of these results in regard to the surgical technique and design features of instruments for osteochondral transplantation is discussed.

Artefacts in the mechanical characterization of porcine articular cartilage due to freezing.

Many experimental protocols for investigating articular cartilage mechanics have involved the use of a freeze-thaw cycle for storage or tissue manipulation. It was hypothesized that mechanical properties are altered due to freeze-thaw cycling. The aim of this study, therefore, was to examine the possibility of protocol-induced artefacts in the mechanical properties of porcine articular cartilage specimens related specifically to freeze-thaw events. Twenty-eight osteochondral specimens [14 from the femoral condyles (FCs) and 14 from the patella-femoral (PF) groove] were tested in confined compression before and after being frozen at -20 degrees C for 7 days. The fluid-independent and fluid-dependent mechanical properties (aggregate modulus of the solid phase and the half-life of stress relaxation respectively) were determined and compared. The aggregate modulus decreased by 13.5 per cent and 20.1 per cent for the PF and FC regions respectively (p = 0.002) and the half-life of the stress relaxation at 10 per cent strain decreased by 6.4 per cent and 12.6 per cent for the PF and FC specimens respectively (p = 0.0341). In conclusion, it has been shown that the protocol used, which involved freezing to -20 degrees C and thawing after 7 days, caused artefacts in the mechanical properties of porcine osteochondral specimens. It is suggested that protocols requiring freezing must be critically reviewed to eliminate such artefacts.

Short-term load bearing capacity of osteochondral autografts implanted by the mosaicplasty technique: an in vitro porcine model.

Articular surface congruency and graft stability are considered essential factors in the success of osteochondral grafting; however, quantitative measures of short-term load bearing capacity of grafts implanted by the mosaicplasty technique have not been reported. The purpose of this study was to develop a live tissue in vitro model to examine short-term fixation strength of mosaicplasty autografts immediately after and 1 week following graft implantation. Cylindrical osteochondral autografts were implanted in vitro by the mosaicplasty technique on five pairs of porcine femoral condyles within one and a half hours of animal sacrifice. Immediately following the surgical procedure, graft push-in and pull-out strength tests as well as indentation tests to determine modulus of the surrounding cancellous bone were performed on half of the specimens from the distal femurs of each animal. The remaining specimens, matched for location in the contralateral leg, were incubated in culture medium for 7 days prior to performing the same set of mechanical tests. Averaged push-in and pull-out graft fixation strength decreased 44% from 135.7 to 75.5N over the 7-day period, while no change in modulus was detected in the surrounding cancellous bone. These in vitro results demonstrate a substantial deterioration of short-term fixation strength of mosaicplasty grafts from the immediate post-operative state. Such a reduction in short-term graft load bearing capacity may pose a threat to the surgically established articular surface congruency and blood vessels formed during the early stages of the healing response.

Activities of daily living in non-Western cultures: range of motion requirements for hip and knee joint implants.

The purpose of this review of the literature was to investigate the functional range of motion requirements of non-Western populations in respect to artificial hip and knee joint implants. It was discovered that in Asia and the Middle East many activities are performed while squatting, kneeling, or sitting cross-legged. These positions demand a greater range of motion than that typically required in Western populations. For example, authors report that to squat one requires 130 degrees-full hip flexion and 111 degrees-165 degrees (or full) knee flexion. To sit cross-legged one requires 90 degrees-100 degrees hip flexion and 111 degrees-165 degrees (or full) knee flexion. This study identified a lack of documented research in this area, and the research that has been done provided inconsistent data. Potential reasons for discrepancies in the data are discussed, including the use of different methods to collect range of motion measurements, unclear use of terminology, and variations in normal passive and active range. In conclusion, this study stresses the importance of culture and function in the design and use of any new joint or product.

Loosening performance of cemented glenoid prosthesis design pairs.

OBJECTIVE: The purpose of this pilot study (n=3) was to compare the loosening performance of glenoid prosthesis design pairs where only one design variable differed. DESIGN: Glenoids were subjected to dynamic edge loading in a biaxial test setup. BACKGROUND: Glenoid component loosening is the primary concern in total shoulder arthroplasty. METHODS: After the humeral head was cycled 100,000 times to the superior and inferior edges of the glenoid, the tensile edge displacements were measured under superior and inferior off-center loading. RESULTS AND CONCLUSIONS: Based on this study, a rough-backed design had dramatically better loosening performance than a smooth-backed; curved-backed was superior to flat-backed; a less-constrained articular surface was better than a more-constrained articular surface; pegs outperformed a keel; threaded pegs were marginally preferable to cylindrical pegs; and an all-polyethylene design rocked slightly less than a metal-mesh-backed design. RELEVANCE: A comparison of the laboratory loosening behavior of glenoid prostheses may lead to improved designs, subsequently leading to a reduction in the incidence of clinical loosening.

Review of arm motion analyses.

Interest in arm movements has increased tremendously in recent years. This interest has been motivated by different goals: the desire for a more scientific approach to replacement or support of the joints of the upper limb, the need for input to biomechanical computer models, and the clinical interest in comparing normal movements with pathological movements. The availability of commercial marker-tracking systems has facilitated achieving these goals. However, the complex nature of arm movements and the lack of standardized movements raises many challenges. In comparison with gait analysis, few arm motion analyses have been conducted. The purpose of this review is to aid researchers and clinicians interested in conducting an arm motion study in choosing the appropriate methodology. This is accomplished both by describing the methods used in past investigations and by highlighting important findings. Due to the variety of research goals, there is sometimes more than one appropriate method and the choice is left to the reader. Nevertheless, since it is extremely desirable to record and express the data in a standardized way, standardization proposals are described. This review, which focuses on methodology rather than results, addresses the following topics: motivations and tasks studied, tracking methods, the shoulder complex, joint centres and rotation axes, marker positions, coordinate system definitions, terminology and rotations, accuracy, and presentation methods.

Mechanical testing of shoulder prostheses and recommendations for glenoid design.

Glenoid component loosening generates the greatest concern among surgeons performing total shoulder arthroplasty. Laboratory testing of glenoid prostheses may lead to improved design, subsequently leading to a reduction in the incidence of clinical loosening. The goals of this study were to develop a laboratory test method to address glenoid loosening and to apply this method to a variety of prosthesis designs. With use of a biaxial apparatus, glenoid components were cyclically subjected to superoinferior edge loading, mimicking the off-center rocking-horse phenomenon thought to contribute to glenoid loosening clinically. Before and after the rocking test was performed, compression and distraction of the superior and inferior edges were measured with the humeral head displaced to each edge. Rocking performance could not be predicted from initial measurements, indicating the necessity for dynamic loading to evaluate the likelihood of loosening. A roughened fixation surface for outperformed a smooth fixation surface, a curved backing showed almost half the distraction of a flat backing, and a nonconstrained prosthesis distracted less than a more constrained prosthesis.

Shoulder prosthesis subluxation: theory and experiment.

The articular shapes of the humeral and glenoid components in total shoulder arthroplasty affect the loading, translation, and contact stresses in the joint, thereby affecting stability, glenoid loosening, and wear. Experiments were conducted to determine the subluxation load and corresponding translation for 6 types of glenoid components. The effects of shape, size, testing direction, compressive load, testing speed, testing medium, bone substitute properties, and repeated subluxations were investigated and compared with theoretical, rigid-body predictions. The subluxation load, varying from 45% to 98% of the axial load for the prostheses tested, is affected by glenoid constraint (i.e., the maximum slope at the glenoid articular rim), the compressive load, the coefficient of friction, and the deformability of the articular edge. Rigid-body theory overestimated the experimental load, which was not surprising given the visible deformations, but provides a framework to highlight the relevant design parameters. The subluxation translation, ranging from 1 to 13 mm for the prostheses tested, is determined by the glenoid length and by the conformity between the humeral and glenoid radii. Experimental translations were greater than rigid-body predictions for the most conforming prostheses and roughly equal for less conforming prostheses. The goals of this study were to characterize the subluxation load and translation of a variety of types of prostheses, to develop the rigid-body basis for these results, to compare the rigid-body and experimental results, and to locate experimentally the glenoid articular rim for further testing.

Arm motion and load analysis of sit-to-stand, stand-to-sit, cane walking and lifting.

OBJECTIVE: To conduct a pilot study to characterize the hand loads, arm joint angles and external moments corresponding to five activities of daily living demanding of the shoulder, for healthy subjects over 50 years of age. DESIGN: The tasks were sit-to-stand, stand-to-sit, cane walking, lifting a 5 kg box with both hands, and lifting a 10 kg suitcase. BACKGROUND: Arm motion and loading have not been previously studied for functional daily-living tasks involving substantial external loads.Methods. Motion was tracked using an optoelectronic system. Loads were measured using an instrumented chair arm, a force plate, and gravitational and acceleration loads. Six healthy volunteers (3 male, 3 female), mean age 55, with no history of shoulder problems participated in the study. RESULTS: Average peak external moments ranged from 12.3 N m for sitting down into a chair to 27.9 N m for lifting a suitcase. Except for lifting the box, which had much lower loads, average peak hand loads varied from 16% to 19% of body weight (114-134 N). The arcs of motion were larger than for seated activities of daily-living studied previously. CONCLUSIONS: The five tasks studied are commonly performed, yet involve large external moments. Lifting represents the greatest potential loading at the shoulder as it resulted in the highest external moments; furthermore, loads larger than those used in this study might be commonly lifted. RELEVANCE: External moments at the shoulder should not be underestimated, even for activities of daily living.

Evaluating a new mobility device: feedback from women with disabilities in India.

PURPOSE: To gather the opinions of potential wheeled mobility device users at an early stage in the design process to ensure the development of technology which would meet their functional needs. METHOD: Eight women with bilateral lower extremity disabilities living in Gujarat state, India, participated in this study. The women were introduced to a working model of a new wheeled ground mobility device (GADI2) for a brief trial and participated in a feedback interview which solicited information on different aspects of the design, specifically the interface between the device and the user, the physical environment and the sociocultural environment. Both qualitative and quantitative data were collected and analysed. RESULT: Although the overall response to the device was positive, there was a lack of consensus in some of the feedback gathered. There were varying opinions across the participants and recommendations were often in opposition to what would typically be recommended in a traditional rehabilitation setting. CONCLUSIONS: This study investigates and discusses the research findings from a rehabilitation perspective with a focus on the functional versus technical design aspects. The importance of involving potential consumers in the design of technology is highlighted. The small sample size and lack of consensus in some of the results indicates the need for further research and field testing of this new mobility device design.

Glenohumeral contact forces.

Glenohumeral contact forces have only been calculated previously either for simple abduction or for athletic activities. The objective of this study was to determine the glenohumeral contact forces for tasks which are demanding of the shoulder but which would commonly be performed by older people. The functional tasks chosen were using the arms to stand up from and sit down into a chair, walking with a cane, lifting a 5 kg box to shoulder height with both hands, and lifting a 10 kg suitcase. The trunk angles, arm angles and hand loads of six healthy subjects, average age 55 years, were recorded. This information was input into a biomechanical computer model which optimized the muscle force distribution by minimizing the sum of squared muscle stresses subject to constraints on the maximum muscle forces and maintaining the direction of the resultant force within the glenoid fossa. Average contact forces ranged from 1.3 to 2.4 times body weight (930-1720 N), the highest force being for lifting a suitcase. This latter value would be even higher if lifting either a greater load or to a greater height. Thus, contact forces at the shoulder should not be underestimated. This study provides functionally relevant contact forces which can be used for mechanical testing or finite element modelling of shoulder prostheses.

Glenoid cancellous bone strength and modulus.

The objectives of this study were to determine the strength and modulus of glenoid cancellous bone, including regional variations. The motivations were: to select a suitable bone substitute for standardized testing of glenoid prosthesis loosening, to assist in shoulder prosthesis design and to provide input data for finite element analyses. Ten glenoids from eight cadavers (mean age, 81) were tested by in situ indentation. Mean strength ranged from 6.7 to 17 MPa for the ten glenoids, the overall mean being 10.3 MPa. Mean E moduli ranged from 67 to 171 MPa for the individual glenoids, the overall mean being 99 MPa. These values are likely at the lower end of what would be expected for normal bone since strength and modulus decrease with age and the available specimens were older. These values may be appropriate for prosthesis design, however, since mechanical properties are reduced in rheumatoid arthritic bone. Regional trends were very similar for modulus and strength. The strongest region was postero-superior. The central column, correlating with the keel position in many glenoid components, was weaker than both the anterior and posterior regions but deeper. A large drop in strength and modulus below the subchondral layer emphasizes the importance of maintaining this layer during prosthetic replacement.

Designing appropriate rehabilitation technology: a mobility device for women with ambulatory disabilities in India.

Mobility is an essential requirement for personal independence and social participation. For persons with an ambulatory disability, a lack of mobility creates barriers to the realization of these goals. In developed countries, significant research and development has resulted in the technological advancement of assistive devices. Unfortunately, transfer of these technologies to developing countries has proven difficult. Consequently, effort has been directed at designing appropriate technology in these countries--most often in the form of wheelchairs and hand-driven tricycles. For activities within and around the home, however, especially in cultures where many activities are traditionally performed on the floor, wheelchairs and tricycles are often inappropriate solutions. In response to this, a novel mobility device has been designed for use by women with ambulatory disabilities living in rural and low-income areas of India. The device is intended to assist the user in performing activities of daily living which occur within and near the home, and at ground level. To this end, the device conceptually differs from traditional wheelchair designs in that it physically keeps the rider near to the floor. This paper describes the new device as well as the cross-cultural and cross-professional collaborative methodology used in its design.

Fatigue strength testing of hip stems with statistical analysis.

Component fatigue testing, the final step in the development of total joint replacements, is performed to validate the safety of these components against fatigue failure before clinical use. Fatigue test prediction can aid the design of an efficient fatigue-testing program. The objective of this study was to perform an efficient and accurate statistical analysis of component fatigue test results, for the validation of future fatigue test predictions. Testing was performed with two aims: first, to determine the local component stress-force relationship using strain gauges; and second, to provide a statistical description of the fatigue test results. Forty-nine hip stems, in three sizes, were tested in a series of static and fatigue tests. Through effective planning and analysis, a statistical description of the component fatigue test results was determined including, 3-parameter Weibull distributions of life at two stress levels and log-Normal distributions of fatigue strength at various lives up to 5 million cycles.

Finite element stress analysis of a hybrid fracture fixation plate.

Metal plates are commonly used in the operative treatment of bone fractures. Rigid metal plates stabilize the fracture site, maintain good contact between bone fragments and allow early weight bearing and patient mobility. However, treatment with rigid metal plates can cause localized bone atrophy due to stress-shielding and interference with blood circulation, and the weakened bone can refracture after plate removal. A hybrid bone plate system that combines the torsional and bending rigidity of a metal plate with the axial compliance of a polymer insert has been designed. A three-dimensional, quarter-symmetric finite element model was generated for a canine femur diaphysis plated with this metal/polymer hybrid design. A model with a standard metal fixation plate was also generated for comparison purposes. The stress state in the underlying bone was examined for several loading conditions taken from published in vivo studies. The finite element model was used to study the performance of biodegradable polymer inserts in the plate system. The flexible plate reduced stress-shielding effects at the fracture site when subjected to an axial load. The bending strength of the plate was not compromised by the addition of the polymer inserts. Biodegradable inserts further enhanced the performance of the new plate design, transferring less of the axial load to the plate as the inserts broke down.

Changes in mean trabecular orientation in the medial condyle of the proximal tibia in osteoarthritis.

In osteoarthritis of the knee, degenerative changes occur in the articular cartilage and underlying subchondral bone, particularly of the medial tibial condyle. Cancellous bone sclerosis that accompanies osteoarthritis is not only the result of an increase in bone volume fraction but also a change in trabecular structure. In a comparison with age-matched controls (n = 4), osteoarthritis (n = 11) demonstrated a significant (P < or = 0.05) increase in bone volume fraction and trabecular thickness. Overall trabecular orientation in the osteoarthritic group was more vertical or perpendicular to the articular surface than the control group (P < or = 0.05) especially in the trabeculae of the cancellous bone layer closest to the articular surface. These alterations in trabecular bone structure could have significant consequences for the mechanical properties of osteoarthritic bone.

Trabecular microstructure in the medial condyle of the proximal tibia of patients with knee osteoarthritis.

The microstructural characteristics of osteoarthritic subchondral bone in the medial tibial condyle are clearly different from normal age-matched bone. Subchondral sclerosis in osteoarthritis indicates not only an increase in bone volume fraction but also alteration in other microstructural characteristics. Eleven medial tibial condyles were collected from ten subjects during arthroplastic surgery for knee oseoarthritis. They were compared to four medial tibial condyles from four age-matched controls with no history of any bone or joint disorder. Six sections from anterior to posterior and three levels from proximal to distal were evaluated in each medial condyle. Five histomorphometric parameters were measured: bone volume fraction (BVf), trabecular thickness (Tb.Th), trabecular number (Tb.N), trabecular separation (Tb.S), and trabecular connectivity (Tb.C). In general, the osteoarthritic subchondral bone had a higher bone volume fraction than control bone but the microstructure was characterized by fewer, widely spaced, thicker than normal trabeculae. There were also highly localized regional differences by depth from the articular surface and from anterior to posterior across the medial condyle. These variations in OA subchondral bone microstructure may significantly affect biomechanical competence of bone in a way not predictable by bone volume fraction measurements alone.

Biodegradable controlled antibiotic release devices for osteomyelitis: optimization of release properties.

Controlled antibiotic release films, melt-extruded cylinders, and suspension-extruded/coated cylinders were manufactured from biodegradable poly(D,L-lactide) (PDLLA) and poly(D,L-lactide-co-epsilon-caprolactone). These devices have potential application in the treatment of osteomyelitis. The in-vitro release properties of the devices were examined with drug loadings varying from 16 to 50%. Gentamicin sulphate films and melt-extruded gentamicin/PDLLA cylinders demonstrated a large initial burst and incomplete release. The films and melt-extruded cylinders made from poly(D,L-lactide-co-epsilon-caprolactone), low mol. wt poly(D,L-lactide), and a mixture of D,L-lactic acid oligomer and high mol. wt poly(D,L-lactide), did not remain intact during the entire release period. While this is undesirable, these materials do have the advantage of not requiring a processing temperature of greater than 110 degrees C. Antibiotic release from high mol. wt PDLLA-coated gentamicin/PDLLA cylinders, with 40 and 50% loading, was very rapid. The antibiotic could only diffuse out through the open ends of the cylinder. Coated gentamicin sulphate cylinders with 20 and 30% drug loading gave the most promising properties in terms of a small initial burst, and a gradual and sustained release. The release rate and duration from the coated cylinders could be adjusted by cutting the cylinder into different lengths; the time required for 90% of the entrapped gentamicin to be released into water from 30% loaded PDLLA-coated cylinders 0.2, 0.4, 0.7 and 1 cm in length was 1000, 1700, 2300, and 2800 h, respectively. This offers a convenient method to adjust the release to meet the specific antibiotic requirement of different patients.(ABSTRACT TRUNCATED AT 250 WORDS)