Size and shape of the resection surface geometry of the osteoarthritic knee in relation to total knee replacement design.

This study examines the resection surface geometry of the femur, tibia, and patella in relation to the design of total knee implants. Using a technique known as principal component analysis (PCA), the variation in the resection geometry of the knee was summarized. Of the total variation of the knee, 58 per cent was due to variation in size and 14 per cent was due to varying femoral intercondylar notch width. A PCA was performed on each bone separately and it was found that 60 per cent, 76 per cent and 71 per cent of variation was due to size for the femur, tibia, and patella respectively. Femoral and tibial size were highly correlated (r = 0.95) while patellar size had poorer correlation with both femoral and tibial size (r < 0.7). Simple linear dimensions (femoral epicondylar width or tibial mediolateral width) were reliable indicators of knee size. The effect of shape variation, which is generally not accounted for in implant design, was measured. The resected surfaces of each subject were compared with a model of the resection surfaces of the knee which varied in size but not shape. The maximum overhang and underhang of the model on the resection surfaces were measured. There was average maximum model overhang of 3.6 mm and underhang of 3.9 mm in the femur, 2.3 mm overhang and 1.9 mm underhang in the tibia, and 2.6 mm overhang and 2.5 mm underhang in the patella. The maximum coverage that an implant can be expected to provide for a population is quantified. Implant designs which include some shape as well as size variation improve on the implant fit.

The influence of design, materials and kinematics on the in vitro wear of total knee replacements.

Debris-induced osteolysis due to surface wear of ultra high molecular weight polyethylene (UHMWPE) bearings is a potential long-term failure mechanism of total knee replacements (TKR). This study investigated the effect of prosthesis design, kinematics and bearing material on the wear of UHMWPE bearings using a physiological knee simulator. The use of a curved fixed bearing design with stabilised polyethylene bearings reduced wear in comparison to more flat-on-flat components which were sterilised by gamma irradiation in air. Medium levels of crosslinking further improved the wear resistance of fixed bearing TKR due to resistance to strain softening when subjected to multidirectional motion at the femoral-insert articulating interface. Backside motion was shown to be a contributing factor to the overall rate of UHMWPE wear in fixed bearing components. Wear of fixed bearing prostheses was reduced significantly when anterior-posterior displacement and internal-external rotation kinematics were reduced due to decreased cross shear on the articulating surface and a reduction in AP displacement. Rotating platform mobile bearing prostheses exhibited reduced wear rates in comparison to fixed bearing components in these simulator studies due to redistribution of knee motion to two articulating interfaces with more linear motions at each interface. This was observed in two rotating platform designs with different UHMWPE bearing materials. In knee simulator studies, wear of TKR bearings was dependent on kinematics at the articulating surfaces and the prosthesis design, as well as the type of material.

Investigation of wear of knee prostheses in a new displacement/force-controlled simulator.

The performance of two knee simulators designed by ProSim (Manchester, UK) was evaluated by comparison of the wear seen in the press-fit condylar (PFC) Sigma (DePuy) knee prosthesis. Twelve specimens of the same design and manufacturing specification, were subjected to a wear test of 2 x 10(6) cycles duration using bovine serum as a lubricant. The anterior/posterior displacement and internal/external rotation inputs were based on the kinematics of the natural knee. International Standards Organization (ISO) standards were used for the flexion and axial load. The wear rates and wear scar areas were compared across all stations. The mean wear rates found were 17.6+/-5 mm3/10(6) cycles for stations 1 to 6 and 19.6+/-4 mm3/10(6) cycles for stations 7 to 12, resulting in an overall mean wear rate of 18.1+/-3 mm3/10(6) cycles. The differences between the two simulators were not significant. The average wear scar area seen on inserts from stations I to 6 was calculated at 32.4+/-1 per cent of the intended articulating surface. Similarly on stations 7 to 12 the average wear scar area was 30.7+/-3 per cent. The wear scars seen were a good physiological representation of those found from clinical explant data. This study has shown good repeatability from the simulator, both within and between the simulators.

Simulation of tibial counterface wear in mobile bearing knees with uncoated and ADLC coated surfaces.

A multidirectional pin-on-plate reciprocating machine was used to compare the wear performance of UHMWPE sliding against cast cobalt chrome (CoCr) plates that were either untreated or coated with Amorphous Diamond Like Carbon (ADLC). The test conditions were based on a 1/5 scale model representative of in vivo motion at the tibial counterfaces of unconstrained mobile bearing knees. The average +/- STERR wear rates were 13.78+/-1.06 mm3/Mcycles for the ADLC counterfaces and 0.504+/-0.12 mm3/Mcycles for the control CoCr counterfaces. All of the pins run on the ADLC counterfaces exhibited the same patterns of blistering along the central axis, and severe abrasion elsewhere to the extent that all of the original machining marks were removed after just one week of testing. The average value of friction coefficient was 0.24 for the ADLC counterfaces and 0.073 for the control CoCr counterfaces. The factor of 3.5 increase was statistically significant at p < 0.05. In the tribological evaluation of ADLC coatings for tibial trays in mobile bearing knees, this study shows that this specific Physical Vapour Deposition (PVD) ADLC showed significantly poorer frictional and wear performance than uncoated surfaces which was sufficient to negate any potential benefits of improved resistance to third body damage.

Quantification of third body damage to the tibial counterface in mobile bearing knees.

Fourteen pairs of explanted low contact stress (LCS) tibial interface components: six rotating platform (RP), six meniscal (MN) and two anterior-posterior (AP) glide designs, have been analysed with particular attention paid to the condition of the tibial counterfaces. The average surface roughness, Ra, for the tibial trays ranged from 0.01 to 0.087 micron, significantly greater than the unworn control measurement of 0.008 micron. The scratch geometry analysis showed that the scratch peaks were found to be consistently of a lower aspect ratio than the scratch valleys and under 1 micron in height (average asperity height Rp = 0.52 micron, aspect ratio delta p = 0.01, average asperity depth Rv = 1.10 microns, delta v = 0.05). The largest scratches were 3-4 microns in both Rp and Rv. In vitro tests have shown that ultra-high molecular weight polyethylene (UHMWPE) wear increases in the presence of counterface scratches perpendicular to the direction of motion. In these explants, the unidirectional motion produced scratches parallel to the direction of sliding which is predicted to produce a smaller increase in UHMWPE wear. Other designs in mobile bearing knees have less constrained motion at the tibial counterface and this has been shown to accelerate wear; it may also lead to a further increase in wear in the presence of third body scratches. It may be possible in future knee designs to reduce this type of wear damage by introducing alternative materials or coatings which are more resistant to scratching and surface roughening.

Comparison of wear in a total knee replacement under different kinematic conditions.

A six station ProSim (Manchester, UK) knee simulator was used to assess the wear of six PFC (DePuy) fixed bearing total knee replacements under two different kinematic conditions defined as low and high kinematic inputs. The high kinematics displacement and rotation inputs were based on the kinematics of the natural knee with ISO standards used for the axial load and flexion. Low kinematics were defined as approximately half the magnitude. The six specimens were run for three million cycles under low kinematics and three million cycles under high kinematics. The mean wear rate found during the low kinematics phase was 7.7 +/- 2 mm3 per million cycles. This then increased significantly to an average wear rate of 41 +/- 14 mm3 during the high kinematics input phase. The wear areas were characterized by a predominant damage mode of burnishing with some abrasive wear occurring during the high kinematics phase. This study supports the findings that introduction of cross-shearing of the polyethylene by introducing both rotational and anterior/posterior displacement increases the wear rate. This has implications for younger patients with higher levels of activity that need knee replacements.

Wear of fixed bearing and rotating platform mobile bearing knees subjected to high levels of internal and external tibial rotation.

In order to extend the lifetime of total knee replacements (TKR) in vivo, reduction of the volumetric wear rate of ultra high molecular weight polyethylene (UHMWPE) bearings remains an important goal. The volume of wear debris generated in fixed bearing total knee devices increases significantly when subjected to higher levels of internal-external rotation and anterior-posterior displacement. Six PFC Sigma fixed bearing TKR were compared with six LCS rotating platform mobile bearing knees using a physiological knee simulator with high rotation kinematic inputs. The rotating platform polyethylene inserts exhibited a mean wear rate which was one-third of that of the fixed bearing inserts despite having increased femoral contact areas and additional tibial wear surfaces. The rotating platform design decouples knee motions, by allowing unidirectional motion at the tray-insert articulation, which reduces rotation at the femoral-insert counterface. This translation of complex knee motions into more unidirectional motions results in molecular orientation of the UHMWPE and reduced volumetric wear.

An experimental model of tibial counterface polyethylene wear in mobile bearing knees: the influence of design and kinematics.

Current designs of mobile bearing knees have different kinematics at the tibial counterface articulation; unidirectional represented by linear tracks and rotating platform designs, and multidirectional represented by reduced constraint designs with motion of the tibial surface in A-P and M-L directions simultaneously. One fifth scale experimental models of the tibial counterface articulation have been developed with mean contact stresses of 0.6 MPa. The unidirectional model had a linear reciprocating motion with a 10 mm stroke, the multidirectional model had a reciprocating motion with a 10 mm stroke and simultaneous rotation of +/- 7.5 degrees. Six specimens of GUR415 polyethylene were tested for each model, sliding on polished cobalt chrome counterfaces with Ra < 0.01 micron in 25% bovine serum lubricant. The mean +/- STERR wear rates were: unidirectional 0.045 +/- 0.015 mm3/million cycles and multidirectional 0.44 +/- 0.15 mm3/million cycles. Applying the scaling factor of 5, the predicted wear rates in actual knee prostheses were: unidirectional 0.23 mm3/million cycles and multidirectional 2.2 mm3/million cycles. The order of magnitude increase in wear rate was statistically significant (p = 0.05).

An axisymmetric contact model of ultra high molecular weight polyethylene cups against metallic femoral heads for artificial hip joint replacements.

Contact mechanics of ultra high molecular weight polyethylene (UHMWPE) cups against metallic femoral heads for artificial hip joints is considered in this study. Both the experimental measurement of the contact area and the finite element prediction of the contact radius, maximum contact pressure and maximum Von Mises stress have been carried out for a wide range of contemporary artificial hip joints. Good agreement of the contact radius has been found between the experimental measurements and the finite element predictions based upon an elastic modulus of 1000 MPa and a Poisson's ratio of 0.4 for UHMWPE material under various loads up to 2.5 kN. It has been shown that the half contact angle for all the cup/head combinations considered in this study is between 40 degrees and 50 degrees under a load of 2.5 kN. The importance of this result has been discussed with respect to the anatomical position of the cup when placed in the body and the selection of a simple wear-screening test for artificial hip joints. The predicted contact radius and maximum contact pressure from the finite element model have also been compared with a simple elasticity analysis. It has been shown that the difference in the predicted contact radius between the two methods is reduced for more conforming contacts between the femoral head and the acetabular cup and smaller UHMWPE cup thickness. However, good agreement of the predicted maximum contact pressure has been found for all the combinations of the femoral head and the acetabular cup considered in this study. The importance of contact mechanics on the clinical performance of artificial hip joint replacements has also been discussed.

A comparative tribological study of the wear of composite cushion cups in a physiological hip joint simulator.

A composite cushion acetabular cup for a total hip replacement has been designed and developed jointly by Leeds University and DePuy International. In order to assess the long-term performance of this novel design, two sets of simulator tests of more than 4 million cycles duration have been carried out with the cushion bearings using the Leeds PA hip joint simulator with bovine serum as the lubricant. The results of these simulator tests were compared to the results from a previously reported study that used 32 mm ultrahigh molecular weight polyethylene (UHMWPE) acetabular cups. Under a physiological walking cycle simulation, with continuous cyclic motion and loading, the composite cushion cups produced negligible wear compared to a volumetric wear rate of 32 mm3 per million cycles for the conventional UHMWPE acetabular cups. This study has demonstrated for the first time the beneficial effects of fluid film lubrication in reducing wear in composite cushion acetabular cups.

Contact pressure prediction in total knee joint replacements. Part 2: Application to the design of total knee joint replacements.

The general elasticity contact theory for elliptical geometry developed in Part 1 (1) has been applied to the design of current total knee joint replacements. A two-step curve-fitting technique using cubic spline interpolation routines has been adopted to represent the full elasticity solutions. The curve fit results of the maximum contact pressure have been compared with the full elasticity solution for a specified elliptical geometry and different polyethylene thicknesses and good agreement has been demonstrated. The computing time required by the curve-fitting technique is very small compared with the full elasticity solution and therefore can readily be applied to the design of knee joint replacements. Furthermore, reasonable agreement has also been found for the contact area for a typical knee joint design between the present theoretical prediction and the experimental measurement using pressure-sensitive film. Predictions of the maximum contact pressure have been made for an existing knee joint replacement in order to illustrate the present analysis in the design cycle. It has been shown that the effect of the thickness of ultra high molecular weight polyethylene is relatively small on contact stress predictions provided a sufficiently large value is chosen. On the other hand, the effect of conformity has a much greater influence on the contact stress distribution, particularly in the direction of the smaller principal radius.

Experimental and theoretical study of the contact mechanics of five total knee joint replacements.

The tibio-femoral contact area in five current popular total knee joint replacements has been measured using pressure-sensitive film under a normal load of 2.5 kN and at several angles of flexion. The corresponding maximum contact pressure has been estimated from the measured contact areas and found to exceed the point at which plastic deformation is expected in the ultra-high molecular weight polyethylene (UHMWPE) component, particularly at flexion angles near 90 degrees. The measured contact area and the estimated maximum contact stress have been found to be similar in magnitude for all of the five knee joint replacements tested. A significant difference, however, has been found in maximum contact pressure predicted from linear elasticity analysis for the different knee joints. This indicates that varying amounts of plastic deformation occurred in the polyethylene component in the different knee designs. It is important to know the extent of damage as knees with large amounts of plastic deformation are more likely to suffer low cycle fatigue failure. It is therefore concluded that the measurement of contact areas alone can be misleading in the design of and deformation in total knee joint replacements. It is important to modify geometries to reduce the maximum contact stress as predicted from the linear elasticity analysis, to below the linear elastic limit of the plastic component.

Cushion form bearings for total knee joint replacement. Part 1: Design,friction and lubrication.

Cushion knee prostheses have been designed and constructed that produce approximately equal initial contact areas and theoretical film thicknesses compared with a conventional UHMWPE (ultra-high molecular weight polyethylene) joint. These compliant bearings had a flat tibial component which imposed fewer biomechanical constraints and allowed a greater range of movement. Friction experiments have been carried out on a pendulum simulator apparatus. The results showed that the cushion knee joints operated just within the mixed lubrication regime, but that they benefited from a substantial measure of fluid film lubrication. Microelastohydrodynamic lubrication was effective in preserving low friction and thin but effective lubricating films.

Cushion form bearings for total knee joint replacement. Part 2: Wear and durability.

Cushion knee prostheses have been designed and constructed to produce larger initial contact areas and thicker theoretical film thicknesses than a conventional UHMWPE (ultra-high molecular weight polyethylene) joint. The compliant bearing had a flat tibial component which imposed fewer biomechanical constraints and allowed greater range of movement. Wear tests were performed in a knee joint simulator and creep tests were carried out in a servo-hydraulic apparatus. Various failure modes of cushion joints that require further study were identified. However, the results showed that adequate durability was achieved from a 20 MPa polyurethane material in joint simulating tests carried out over 0.5, 1.0 and 5.0 million cycles. Most importantly, during these tests, no detectable wear debris was generated. It is believed that this is the first time that the full potential of cushion bearings has been demonstrated in a joint simulator over periods corresponding to about five years of service in vivo.

Friction and lubrication in cushion form bearings for artificial hip joints.

Two hip joint prostheses were designed and constructed to be elastohydrodynamically equivalent producing approximately equal initial contact areas and theoretical film thicknesses. One was made from conventional UHMWPE (ultra-high molecular weight polyethylene) and the other was a cushion component which had a low modulus layer introduced into the joint space. Friction measurements were carried out on a pendulum simulator apparatus and the two joints were compared. In addition the experimental results were compared with theoretical values of friction predicted from elastohydrodynamic lubrication theory. Values for the friction factor at peak load and peak velocity in the cushion cup (0.003-0.009) were much lower than in the UHMWPE cup (0.017-0.042). The low friction values in the cushion cup are consistent with fluid film lubrication in the contact with the thin lubricating film being preserved by microelastohydrodynamic action.

Design considerations for cushion form bearings in artificial hip joints.

Lubrication mechanisms and contact mechanics have been analysed in a new generation of 'cushion form' bearings for artificial hip joints, which comprise low elastic modulus layers on the articulating surfaces. Comparisons have been made with 'hard' bearings used in existing prostheses and also with the natural hip joint. Lubricating film thicknesses are enhanced by larger contact areas and lower contact pressures. For a fixed contact area, simultaneous changes in layer thickness and radial clearance have been shown to have a small effect on elastohydrodynamic film thickness. Hard bearings designed with the same contact area as the cushion bearings produced a similar film thickness, but lubricant film thickness is not optimized in current designs. The main advantage of using a cushion bearing with low elastic modulus layers was found to be associated with microelastohydrodynamic lubrication. Careful selection of the elastic modulus is important in order to ensure that this lubrication regime was effective. Low elastic modulus layers may also produce local deformations, which enhance squeeze film action. The elastic modulus of the material should not be lower than necessary to produce effective microelastohydrodynamic lubrication, as a further reduction in modulus only increases the strain distribution in the material. A lubricant film thickness of 0.3 microns has been predicted for a cushion hip prosthesis with a femoral head diameter of 32 mm and radius of contact zone of 16 mm, using a 2 mm thick layer with an elastic modulus of 20 MPa.