Compliant layer bearings in artificial joints. Part 2: simulator and fatigue testing to assess the durability of the interface between an elastomeric layer and a rigid substrate.

Artificial joints have been much improved since their introduction but they still have a limited lifetime. In an attempt to increase their life by improving the lubrication acting within these prostheses, compliant layered polyurethane (PU) joints have been devised. These joints mimic the natural synovial joint more closely by promoting fluid film lubrication. In this study, tests were performed on compliant layer joints to determine their ability to function under a range of conditions. Both static and dynamic compression tests were undertaken on compliant artificial hip joints of two different radial clearances. Friction tests were also performed before and after static loading. In addition to this, knee wear tests were conducted to determine the suitability of a compliant layer in these applications. In the knee tests, variations in experimental testing conditions were investigated using both active and passive rotation and severe malalignment of the tibial inserts. The static compression tests together with the friction studies suggest that a small radial clearance is likely to result in 'grabbing' contact between the head and cup. The larger radial clearance (0.33 microm) did not exhibit these problems. The importance of the design of the compliant layer joints was highlighted with delamination occurring on the lateral bearings during the knee wear studies. The bearings with a layer 2 mm thick performed better than the bearings with a layer 3 mm thick. Tests conducted on flat PU bearings resulted in no delamination; therefore, it was concluded that the layer separation was caused by design issues rather than by material issues. It was found that, with careful material choice, consideration of design, and effective manufacturing techniques, the compliant layer joint functioned well and demonstrated durability of the union between the hard and soft layers. These results give encouragement for the suitability of these joints for clinical use.

The effect of bone cement particles on the friction of polyethylene and polyurethane knee bearings.

Compliant layer knee joints have been considered for use in an attempt to increase the serviceable life of artificial joints. If designed correctly, these joints should operate within the full-fluid film lubrication regime. However, adverse tribological conditions, such as the presence of bone and bone cement particles, may breach the fluid film and cause surface wear. The frictional behaviour of both polyurethane (PU) and conventional polyethylene (PE) tibial components against a metallic femoral component was therefore assessed when bone cement particles were introduced into the lubricant. The bone cement particles caused a large increase in the frictional torque of both the PE and PU bearings; however, the friction produced by the PU bearings was still considerably lower than that produced by the PE bearings. The volume of bone cement particles between each of the bearings and the resultant frictional torque both decreased over time. This occurred more quickly with the PE bearings but greater damage was caused to the surface of the PE bearings than the PU components.

Relative movements between Kinemax Plus tibial inserts and the tibial base-plates.

Tests were performed on six large Kinemax Plus knee bearings (snap-fit design) to evaluate the amount of movement between 10- and 15-mm-thick tibial inserts and the tibial base plates. The knee bearings were tested up to 1 x 10(6) cycles on the Durham six-station knee wear simulator which subjected the bearings to similar motion and loading profiles that would be experienced by the natural knee during walking. Although passive internal/external (I/E) rotation was allowed, no active I/E rotation was applied. The movement of the tibial inserts was measured with dial gauges (accuracy +/-0.01 mm) before and after the bearings were tested on the simulator, when unloaded, and throughout the tests while the bearings were being dynamically loaded in the simulator. Movement occurred between the tibial insert and the tibial base plate after initial assembly due to the snap-fit mechanism used to locate the tibial insert within the tibial base plate. However this decreased appreciably when the bearings were loaded in the simulator. The amount of movement did not change with time when the bearings were continuously loaded in the simulator. However, after each test the amount of movement of the tibial inserts, when unloaded, was only 65 per cent (anterior-posterior) and 46 per cent (medial-lateral) of the values before the test. This was thought to be due to creep of the ultra-high molecular weight polyethylene (UHMWPE) inserts. The movement between the tibial insert and tibial base plate in situ is likely to be much less than that observed by a surgeon at the time of assembly due to loading of the knee bearing in the body. However, the amount of movement when the tibial inserts are loaded may still be great enough to produce a second interface where wear of the tibial insert may take place.

Long-term results for Kinemax and Kinematic knee bearings on a six-station knee wear simulator.

A long-term wear test was performed on Kinemax and Kinematic (Howmedica Inc.) knee bearings on the Durham six-station knee wear simulator. The bearings were subjected to flexion/extension of 65-0 degrees, anterior-posterior translation of between 4.5 and 8.5 mm and a maximum axial load of 3 kN. Passive abduction/adduction and internal/external rotation were also permitted, however, two of the stations had a linkage system which produced +/- 5 degrees active internal/external rotation. The bearings were tested at 37 degrees C in a 30 per cent bovine serum solution and the test was run to 5.6 x 10(6) cycles. The bearings from stations 2 and 3, and stations 4 and 5 were swapped during the test to investigate the effects of interstation variability. The average wear rate and standard error was 3.00 +/- 0.98 mg/10(6) cycles (range 1.33-4.72 mg/10(6) cycles) for the Kinemax bearings and 3.78 +/- 1.04 mg/10(6) cycles (range 1.87-4.89 mg/10(6) cycles) for the Kinematic bearings. There were no significant differences in wear rates between the different bearing designs, the addition of active internal/external rotation or a change of stations. However, the wear tracks were different for the two types of bearings and with active internal/external rotation. The wear rates and factors were generally lower than previously published in vitro wear results; however, this may have been due to a difference in the axial loads and lubricants used. The appearance of the wear tracks with active internal/external rotation was comparable with those seen on explanted knee bearings.

A tribological study of UHMWPE acetabular cups and polyurethane compliant layer acetabular cups.

A novel design of polyurethane compliant layer acetabular cup has been developed through a series of friction, creep and wear tests. Friction tests were initially conducted on ABG standard form, polyurethane acetabular cups and an ABG standard form, UHMWPE acetabular cup for comparison. The polyurethane cups showed lower friction than the UHMWPE cup with maximum friction factors between 0. 008 and 0.02 compared with 0.035 for the UHMWPE cup. This indicated that, in the polyurethane cups, more of the load across the joint was carried by the fluid entrapped in the joint space rather than with asperity contact, compared with the UHMWPE cup. The inherent compliance of the polyurethane is used to promote elasto-hydrodynamic lubrication. However, this compliance raised concerns over excessive creep, which may in turn adversely affect tribological performance. Therefore, creep tests were undertaken on the ABG standard form, polyurethane acetabular cups followed by further friction tests. Small amounts of creep occurred in the polyurethane cups at ambient temperature, which reduced the friction slightly (maximum friction factors of 0.009) due to increased conformity between the head and the cup. However, at 37 degrees C, greater creep occurred causing pinching of the femoral head by the acetabular cup resulting in lubricant starvation and higher friction (maximum friction factors of 0.035). The design of the polyurethane cups was subsequently modified to incorporate a flared rim to eliminate the possibility of fluid starvation through pinching. Creep in polyurethane acetabular cups is also affected by the method of fixation of the cups, due to the conformity with and the stiffness of the cup backing. Hence, a one-million-cycle wear test was performed on five ABG flared form, polyurethane acetabular cups on the Mk. I Durham Hip Joint Wear Simulator to evaluate the best method of fixation for the polyurethane cups. The smallest amount of penetration, due to creep and wear, was found with cement fixation (0.30 mm penetration with cement fixation, 0.44 mm with polyethylene holder mounting, and 0.52 mm with metal shell mounting). A 4. 25-million-cycle wear test was then conducted on a further five ABG flared form, polyurethane acetabular cups with cement fixation. Five ABG standard form, UHMWPE acetabular cups were also wear-tested to 5. 0-million cycles. The mean and standard error of the wear rate for the polyurethane cups were 14.1 +/- 4.3 mg/10(6) (12.0 +/- 3.6 mm(3)/10(6)), cycles compared with 44.8 +/- 3.4 mg/10(6) (48.2 +/- 3. 7 mm(3)/10(6)), cycles for the UHMWPE cups. This study showed that the novel polyurethane-compliant layer acetabular cup with cement fixation was tribologically superior to the ABG standard form UHMWPE design currently being used clinically.

Design of a surface replacement prosthesis for the proximal interphalangeal joint.

A surface replacement finger joint prosthesis was designed specifically for the proximal interphalangeal joint (PIPJ). The two-piece design consisted of a bi-condylar proximal phalangeal head and a conforming bi-concave middle phalangeal base. The bearing surfaces were designed as close to the original anatomy of the PIPJs as possible, using detailed information obtained from a previous anatomical study of 83 PIPJs by the present authors. Four sizes of prosthesis were designed with maximum head diameters of 7, 8, 9 and 10 mm. Fixation of the joint prosthesis was achieved by an interference fit between the stems of semicircular cross-section and the phalangeal bone shafts. The main considerations for the stem designs were the offset from the centre of rotation, angle of inclination, length, and cross-sectional shape and size. It is proposed that the two components will be made from cross-linked polyethylene (XLPE) because it can be injection moulded to produce the complex shapes of the joint prosthesis. In addition, XLPE against itself has shown comparable wear rates with stainless steel against ultra-high molecular weight polyethylene from previous work by Joyce et al.

Further studies into proximal interphalangeal joint dimensions for the design of a surface replacement prosthesis: medullary cavities and transverse plane shapes.

The proximal and middle phalanges from 83 proximal interphalangeal joints (PIPJs) were set in clear plastic and sectioned in the transverse plane leaving the heads whole. The sections were cleaned, shadowgraphed and measured. The medullary canals were marked on sagittal and frontal plane shadowgraphs of the intact bones and analysed. The information was then used in the design of a surface replacement prosthesis for the PIPJs. The main dorsal surface of the proximal phalanx (PP) was found to be angled to the longitudinal baseline of the bone by a mean of 5.19 degrees. This angle increased just proximal to the phalangeal head to a mean of 11.84 degrees. The mean ratio between these angles was 2.71. The phalangeal shaft bone was thicker laterally than dorsally and palmarly, and thicker dorsally than palmarly for the proximal and middle phalanges throughout the length of the bone. The shape and size of the transverse cross-section of the medullary canal changed throughout the length of the shaft. The centreline of the PP medullary canal coincided with the midline of the bone in the frontal plane and was approximately a straight line along the length of the canal. In the sagittal plane the centreline was slightly palmar to the midline and the angle between it and the longitudinal baseline of the bone changed along the length of the canal. In the region of the shaft just proximal to the PP head (where the stem of a surface replacement prosthesis would fit) the mean angle was 10.63 degrees. The centreline was offset dorsally from the centre of rotation of the PIPJ by a mean of 0.83 mm, 0.83 mm, 0.80 mm and 0.57 mm for the index, middle, ring and little fingers respectively, with an overall mean of 0.76 mm. The mean PP head heights (transverse plane) were 9.17 mm, 9.33 mm, 8.73 mm and 7.40 mm and the mean PP widths (transverse plane) were 12.86 mm, 13.25 mm, 12.75 mm and 10.54 mm for the index, middle, ring and little fingers respectively. The mean angle between the lateral sides of the condyles to the transverse baseline was 78.35 degrees and the mean distance from the centreline of the PP head (transverse plane) to the bases of the two condyles was 4.69 mm. The mean maximum depth of the PP head intercondylar sulcus in the frontal plane was 0.72 mm and in the transverse plane, the mean maximum depth of the intercondylar sulcus on the anterior face was 0.82 mm.

Proximal interphalangeal joint dimensions for the design of a surface replacement prosthesis.

The bones from 83 proximal interphalangeal joints (PIPJs) were dissected in order to determine the shape and size of the articular surfaces. The bones were modelled in acrylic dental bone cement and the original bones and replicas were then sectioned and shadowgraphed. Dimensions were taken from these shadowgraphs to be used in the design of a surface replacement prosthesis for the PIPJ. It was found that the bi-condylar heads of the proximal and middle phalanges were circular in the sagittal plane as was the base of the middle phalanx. However, the radius of curvature of the middle phalangeal base was greater than that of the proximal phalangeal head indicating that the PIPJ is not a conforming joint. The alignment of the radial and ulnar condyles of the proximal phalangeal bones was investigated and it was found that the index and middle finger bones tended to have a more prominent ulnar condyle while the ring and little finger bones tended to have a more prominent radial condyle. This was due to a slight difference in diameters of the two condyles. The proximal phalangeal bone lengths L ranged from 29-52 mm, maximum head widths W from 8.5-15.5 mm and maximum diameters D of the best-fit circles to the sagittal profile of the bone head from 6-11 mm. The middle phalangeal bone lengths ranged from 16-35 mm, maximum head widths from 8.5-12 mm and maximum diameters from 5-7.5 mm. The relationships and ratios between these dimensions for the proximal and middle phalanges have been calculated.

The wear of cross-linked polyethylene against itself.

Cross-linked polyethylene (XLPE) may have an application as a material for an all-plastic surface replacement finger joint. It is inexpensive, biocompatible and can be injection-moulded into the complex shapes that are found on the ends of the finger bones. Further, the cross-linking of polyethylene has significantly improved its mechanical properties. Therefore, the opportunity exists for an all-XLPE joint, and so the wear characteristics of XLPE sliding against itself have been investigated. Wear tests were carried out on both reciprocating pin-on-plate machines and a finger function simulator. The reciprocating pin-on-plate machines had pins loaded at 10 N and 40 N. All pin-on-plate tests show wear factors from the plates very much greater than those of the pins. After 349 km of sliding, a mean wear factor of 0.46 x 10(-6) mm3/N m was found for the plates compared with 0.021 x 10(-6) mm3/N m for the pins. A fatigue mechanism may be causing this phenomenon of greater plate wear. Tests using the finger function simulator give an average wear rate of 0.22 x 10(-6) mm3/N m after 368 km. This sliding distance is equivalent to 12.5 years of use in vivo. The wear factors found were comparable with those of ultra-high molecular weight polyethylene (UHMWPE) against a metallic counterface and, therefore, as the loads across the finger joint are much less than those across the knee or the hip, it is probable that an all-XLPE finger joint will be viable from a wear point of view.