We report on an innovative surface grafting to highly crosslinked (HXLPE) bearing for THA using a biocompatible-phospholipid-polymer poly (2-methacryloyloxyethyl phosphorylcholine) (PMPC). Such hydrophilic surfaces mimic articular cartilage and are hypothesized to improve lubrication and thereby reduce friction and wear.

We performed in vitro testing of wear and friction of ceramic-on-polyethylene THRs with the PMPC treatment, and compared them with untreated controls. Highly cross-linked UHMWPE bearings, gamma-ray-irradiated at different levels with and without vitamin E (HXL Vit. E: 125 kGy, HXL: 75 kGy, respectively) were divided so half were PMPC treated (n=3 for all four groups). All were paired with identical 40 mm diameter zirconia-toughened-alumina ceramic heads. Testing was carried-out on an AMTI hip simulator for 10 million simulated walking cycles with standard lubricant and conditions (ISO-14242-1). Wear was measured gravimetrically at 21 intervals, and so was frictional torque with a previously described and tested methodology.

PMPC treatment produced a statistically significant 71% in wear reduction of HXL poly (1.70±1.36 mg/Mc for PMPC vs. 5.86±0.402 mg/Mc for controls, p=0.013). A similar significant wear reduction was found for PMPC treated HXL with Vit. E liners (0.736±0.750 mg/Mc, vs. 2.14±0.269 mg/Mc, p=0.035). The improvements were associated with 12% and 5% reductions in friction of the HXL and Vit. E HXL respectively (statistically significant p=0.003, and marginal p=0.116, one tailed).

These results were an important step in the quest for lower wearing, thin and strong UHMWPE liners for larger diameter femoral heads with the potential benefit of longevity and less risk of dislocation after surgery.

To improve the longevity of total hip replacements (THR), it is necessary to prevent wear of the ultra-high molecular weight polyethylene (UHMWPE) bearing, as wear debris can cause osteolysis and aseptic loosening. Highly cross-linked UHMWPE reduces wear, sometimes stabilized with vitamin E to preserve its mechanical properties and prevent oxidative degeneration. An extra novel solution has been grafting the surface of UHMWPE with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC). This treatment uses a hydrophilic (wettable) phospholipid polymer to improve lubrication and reduce friction and wear of the bearing material.

We set out to test the wear and friction of ceramic-on-polyethylene (COP) THRs that had the PMPC surface treatment, or left untreated for control. Four groups of UHMWPE bearings were tested against identical 40mm ceramic heads (zirconia-toughened alumina). The UHMWPE bearings were highly cross-linked with/without vitamin E (HXL Vit. E: 125 kGy radiation dose / HXL: 75 kGy). In each group, half underwent the PMPC treatment (n = 3 for all four groups).

Testing was conducted on an AMTI hip simulator for 10 million walking cycles of ISO-14242-1, at 1 Hz, with diluted bovine serum (30 g/L protein concentration) as lubricant, at 37ºC, and with fluid absorption errors corrected with active soak controls. Using a previously published method, frictional torques and a frictional factor around three orthogonal axes about the femoral head were measured/computed, by data processing of the measurements of a 6-DOF load cell on each station of the hip simulator. Such friction measurements and stops for specimen weighing were carried out at regular intervals throughout the wear test.

The HXL liners without and with the PMPC treatment wore at 5.86±0.402 mg/Mc and 1.70±1.36 mg/Mc, respectively (p=0.013) (Fig. 1). The HXL Vit. E liners without and with the PMPC treatment wore at 2.14±0.269 mg/Mc and 0.736±0.750 mg/Mc, respectively (p=0.035). The wear rates of the untreated HXL and HXL Vit. E liners were significantly different (p=0.0002) but no difference in wear rate was found between the two PMPC treated groups (p=0.179), although, as mentioned above, the PMPC treatment very significantly reduced wear in each case. The ceramic femoral heads showed little wear (weight loss) themselves.

In general, the THRs showed decreasing friction over the 10 Mc, with the PMPC types showing a slight increase in friction towards the end of the test (Fig. 2). PMPC HXL liners showed the lowest friction factor (0.022±0.001) which was significantly lower (p<0.001) than the friction of the untreated liners (0.028±0.002) (Fig. 3). The PMPC HXL Vit. E liners showed lower friction factors than the untreated HXL Vit. E liners (0.034±0.002, 0.036±0.004, respectively), although this difference was not significant (p=0.116). Overall, the liners with the PMPC treatment displayed statistically significantly lower friction factors (p=0.003) than those untreated. The coincidence of some reduction of surface friction with larger wear reduction obviously suggests some but not necessarily full causality.

PMPC successfully reduced both the friction and the wear in these COP THRs during this extended 10 Mc test. This likely would translate to improved implant longevity in patients.

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Artificial knee joints are continuously loaded by higher contact stress than artificial hip joints due to a less conformity and much smaller contact area between the femoral and tibial surfaces. The higher contact stress causes severe surface damage such as pitting or delamination of polyethylene (PE) tibial inserts. To decrease the risks of these surface damages, the oxidation degradation of cross-linked polyethylene (PE) induced by residual free radicals resulting from gamma-ray irradiation for cross-linking or sterilization should be prevented. Vitamin E (VE), as an antioxidant, blended PE (PE(VE)) has been used to solve the problems. In addition, osteolysis induced by PE wear particles, bone cement and metallic debris is recognized as one of the important problems for total knee arthroplasty (TKA). To decrease the generation of PE wear particles, we have developed the bearing surface mimicking the articular cartilage; grafting a biocompatible polymer, poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), onto the PE surface having high wear resistance. In this study, we have evaluated the surface, mechanical under severe oxidative condition, and wear properties of PMPC-grafted cross-linked PE(VE) (PMPC-CLPE(VE)) material for artificial knee joints.

Untreated and PMPC-grafted 0.1 mass% VE-blended PE (GUR1020E resin) with a gamma-ray irradiation of 100 kGy for cross-linking and 25 kGy for sterilization were prepared (CLPE(VE) and PMPC-CLPE(VE), respectively). Surface properties were evaluated by Fourier-transform infrared (FT-IR) spectroscopy and transmission electron microscope (TEM) observations. Surface wettability and frictional property were measured by static water contact angle measurement and ball-on-plate friction test. To evaluate the oxidation degradation resistance, mechanical and physical properties such tensile test, izod impact test, small punch test and cross-link density measurement before and after accelerated aging were measured. Wear properties of the tibial inserts were examined by using knee simulator in the combination of Co-Cr-Mo femoral components according to ISO14243-3. Gravimetric wear, volumetric penetration and the number of generated wear particles were measured.

By the FT-IR measurements and TEM observation, P–O peaks attributed to MPC unit and uniform PMPC layer with 100–200 nm thick was observed only on PMPC-CLPE(VE) surface. Static water contact angle of CLPE(VE) was almost 100 degree, while that of PMPC-CLPE(VE) decreased significantly to almost 35 degree. There was no significant difference in the mechanical and physical properties between CLPE(VE) and PMPC-CLPE(VE). Moreover, both the CLPE(VE) and PMPC-CLPE(VE) maintained these properties even after the accelerated aging of 12 weeks [Fig. 1]. Blended VE in CLPE would act as radical scavengers to prevent oxidation degradation. In the knee simulator wear test, the PMPC-CLPE(VE) tibial inserts showed about a half gravimetric wear compared to the CLPE(VE) tibial inserts [Fig. 2]. This would be due to the significant differences observed in wettability of the surface. Water thin film formed on the hydrated PMPC graft layer, would act as significantly efficient lubricant.

From these results, the PMPC-CLPE(VE) is expected to be one of the great bearing materials not only preventing surface damages due to higher contact stress and oxidation degradation but also improving wear resistance, and to provide much more lifelong artificial knee joints.

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To prevent aseptic loosening resulting from osteolysis induced by polyethylene (PE) wear particles in THA, it is necessary to develop a high wear-resistance bearing material. We have investigated the bearing surface mimicking the articular cartilage; grafting a biocompatible polymer, poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), onto the PE surface. High wear-resistance of PMPC-grafted surface has been revealed in the hip simulator wear test of 20 million cycles. Additionaly, in THA, oxidation degradation induced by residual free radicals resulting from gamma-ray irradiation for cross-linking or sterilization is also regarded as serious issue. Recently, gas plasma (GP) sterilization has been used as a less residual radical sterilization method. In this study, we ask a question: the GP sterilization would affect to PMPC surface and/or PE substrate? Hence, we investigated surface chemical, wear, mechanical, physical and oxidation properties of GP sterilized PMPC-grafted highly cross-linked PE (CLPE).

GP-sterilized CLPE and PMPC-grafted CLPE (CLPE (GP) and PMPC-CLPE (GP), respectively; GUR 1020 resin, 75 kGy irradiation), and 25 kGy-gamma-sterilized PMPC-grafted CLPE (PMPC-CLPE (g); GUR 1020 resin, 50 kGy irradiation) were evaluated. Surface property of PMPC layer was evaluated by X-ray photoelectron spectroscopy (XPS), fourier-transform infrared (FT-IR) spectroscopy, fluorescence microscope and cross-sectional transmission electron microscope (TEM) observations. Wettability and lubrication of the PMPC-CLPE surface were evaluated by static water contact angle measurement and ball-on-plate friction test, respectively. Wear properties of the acetabular cups were examined by using hip simulator in the combination with Co-Cr-Mo femoral heads. To evaluate the GP sterilization effect to the CLPE substrate, tensile test, izod impact test, small punch test, gel content, residual radical concentration and oxidation degradation were conducted. Oxidation degradation was evaluated as oxidation index by using a FT-IR spectroscopy.

By the XPS and FT-IR measurements, phosphorus peak and P-O peak attributed to grafted PMPC were observed, respectively. Uniform PMPC layer (100–200 nm thick) was observed on both surfaces of PMPC-CLPE (g) and PMPC-CLPE (GP) [Fig. 1]. Water contact angle of CLPE (GP) was almost 100 degree, while those for PMPC-CLPE (g) and PMPC-CLPE (GP) decreased dramatically to almost 10 degree. Dynamic coefficient of friction of PMPC-CLPE (g) and PMPC-CLPE (GP) was lower than that for CLPE (GP). In the hip simulator wear test, PMPC-CLPE (g) and PMPC-CLPE (GP) cups showed significantly lower amount of wear than that of CLPE (GP) [Fig. 2]. The number of the wear particles was extremely less in PMPC-CLPE (g) and PMPC-CLPE (GP), though the size was not different of all cases. Water thin film might be formed at the grafted PMPC layer, which acted as significantly efficient lubricant. There was no difference in the mechanical and physical properties among three groups. Oxidation index for PMPC-CLPE (GP) after acceleration of aging was lower than that of PMPC-CLPE (g). The GP sterilization might affect only to the PMPC-grafted surface, whereas gamma irradiation affects also to the PE substrate.

From these results, the PMPC-CLPE (GP) is expected to be one of the great bearing materials having not only high-wear resistance but also high-oxidation resistance, which could give further longevity of implantation.

The modification of bearing surfaces with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) is known to increase the hydration of the surfaces and decrease the wear of the substrates. PMPC grafting to acetabular liner of total hip arthroplasty showed a drastic reduction of cross-linked polyethylene (CLPE) wear in a long-term hip simulator test and achieved a good short-term clinical result. To apply this technique to other joint prostheses, the wear resistance under various conditions needs to be evaluated because every joint has a different wear mode. ASTM F732 gives a method that disk shaped polymer specimen is loaded with hemispherical pin using pin-on-disk tester, which is suitable for hydrated polymer because the lubricant is supplied every loading cycle on the surface. The purpose of this study is to evaluate the performance of PMPC-grafted hydrated CLPE under multidirectional wear condition in anticipation of applying PMPC to various prostheses.

The CLPE disks of 3 or 6-mm in thickness were machined from a bar stock. The PMPC was grafted onto the CLPE surfaces using a photoinduced polymerization of MPC in aqueous medium. All disks were irradiated with a total amount of 75-kGy gamma-ray. The wear resistance of the CLPE and PMPC-grafted CLPE disks against Co-Cr-Mo alloy pin was evaluated using Ortho-POD pin-on-disk tester. The disks were fixed to the tester with a Ti-6Al-4V alloy plate that has screw hole in the center. The test conditions were a static load of 213 N, sliding shape of 5 mm × 10 mm rectangular, frequency of 1 Hz and maximum cycles of 1.0 × 10⁶ [Fig. 1]. Gravimetric wear was determined by weighing the disks and soak controls were used to compensate for the fluid absorption. After the wear test, volumetric changes of sliding and backside surfaces of disks were evaluated using a noncontact optical three-dimensional profiler.

The PMPC-grafted surface showed decrease in the gravimetric wear drastically [Fig. 2]. The thickness of CLPE had no substantial effect on the wear resistance. Three-dimensional profile measurements of sliding surfaces detected a substantial volumetric penetration; the corner of sliding track were deeper than the straight-line portion. Backside extrusion was observed in all disks. The thickness of CLPE affected both volumetric penetration and backside extrusion for both untreated and PMPC-grafted CLPE. The PMPC grafting had no discernible effect on volumetric changes [Fig. 3].

Results of this study revealed: (1) the PMPC-grafted surface decreases wear of CLPE, however, the thickness of disk has no effect, in contrast, (2) thinner thickness of CLPE increases the volumetric changes including penetration in sliding surface and extrusion in back surface but the PMPC-grafted surface has no effect. Gravimetric wear did not correlate with the volumetric penetration in sliding surface because the volumetric penetration might be caused by not only the wear but also the creep deformation. In conclusion, hydrated bearing surface and thickness of bearing substrate are essential for the wear and fatigue resistance properties for an increasing longevity of artificial joint. In addition, PMPC grafting is a promising technique for increasing the longevity of various joint prostheses.

One of serious issues in total hip arthroplasty (THA) is the osteolysis which results in aseptic loosening caused by the wear particles from a polyethylene (PE) acetabular cup. In addition, oxidation degradation of PE cup resulting in the fracture or the severe wear caused by the reduction of mechanical properties in vivo is also the issue. The oxidation degradation is considered to be induced by residual free radicals generated by gamma-ray irradiation for cross-linking to reduce wear or for sterilization. In this study, (1) wear property, (2) oxidation degradation of retrieved PE and highly cross-linked PE (CLPE) cups against alumina ceramic femoral heads, and (3) the correlation between those properties were evaluated.

The radiographic wear of six conventional PE cups with the mean follow-up of 19.1–23.3 years and 60 CLPE cups with the mean follow-up of 3.1–9.1 years were measured by a non-radiostereometric analysis method (Vectorworks^® 10.5 software package). As a retrieval analysis, 26 retrieved acetabular cups were evaluated; 16 cups were ethylene oxide gas-sterilized conventional PE cups with clinical use for 16.0–24.9 years and 10 cups were gamma-ray-sterilized CLPE cups with clinical use for 0.9–6.7 years. The linear and the volumetric wear were measured using a three-dimensional (3D) coordinate measurement machine. The shapes of unworn and worn surfaces with 15- and 30-point intervals, respectively, were measured. Oxidation degradation of the surface, sub-surface and inner for both worn and unworn parts of the retrieved cups was measured using a Fourier-transform infrared (FT-IR) spectroscopy. Oxidation indices were calculated using the peak at 1740 cm⁻¹ and 1370 cm⁻¹ according to ASTM F2012.

In the radiographic analysis, the linear wear rate of CLPE cups was significantly lower than that of conventional PE cups [Fig. 1]. In the retrieval analysis, the linear wear rate of CLPE cups (mean: 0.07 mm/year) showed a 51% reduction (p = 0.002) compared to conventional PE cups (mean: 0.14 mm/year) [Fig. 2]. The retrieval and the radiographic analysis for both conventional PE and CLPE cups showed similar results (p = 0.7 and 0.1, respectively). Maximum oxidation indices for CLPE cups were similar to those of conventional PE cups regardless of the difference of clinical duration [Fig. 3]. This result is different from in vivo wear, which increases as the clinical duration. For both conventional PE and CLPE cups, the oxidation indices of subsurface were higher than those for surface. The worn parts showed higher oxidation indices than those for unworn parts. From the results, even when the free radicals were so few or absent, the oxidation degradation would be induced in vivo.

In conclusion, the wear resistance for CLPE cups was greater than that for conventional PE cups from both radiographic and retrieval analyses. The in vivo oxidation degradation might not be caused by only residual free radicals. It was found that oxidation degradation of PE cups when used with alumina ceramic femoral heads is not correlated to their wear properties.

In total hip arthroplasty (THA), aseptic loosening induced by polyethylene (PE) wear debris is the most important cause that limits the longevity of implants. Abrasive wear generated through the mechanism such that micrometer-roughened regions and small asperities on the metallic femoral heads surface locally plow through the PE cup surface. Abrasive wear results in the PE material being removed from the track traced by the asperity during the motion of the metallic femoral heads surface. For the purpose of reducing wear, alumina ceramics was introduced in Europe and Japan in 1970s. The clinical results of ceramic-on-PE bearings regarding the wear resistance have been superior to that of the metal-on-PE bearings. Compared with Co–Cr–Mo alloys, alumina ceramics is advantageous for precision machining because of its higher hardness, enable to form spherical and smooth surface. The fracture resistance of the alumina ceramics itself is related to grain size; the grain size reduction leads to the improvement of its resistance. In this study, we evaluated the roundness and the roughness of retrieved two distinct alumina ceramics having different grain size, and Co–Cr–Mo alloy heads.

Fourteen retrieved alumina ceramic femoral heads; ten heads with a diameter of 28 mm made of small grain size alumina (SG-alumina; mean grain size is 3.4 μm) with clinical use for 16–28 years and four heads with a diameter of 26 mm made of extra-small grain size alumina (XSG-alumina; mean grain size is 1.3 μm) with clinical use for 14–19 years, were examined. Six retrieved Co–Cr–Mo alloy femoral heads with a diameter of from 22 to 32 mm with average clinical use for 12–28 years were examined.

SG-alumina and XSG-alumina heads showed significantly lower roundness compared with Co–Cr–Mo alloy heads, due to higher precision machining [Fig. 1]. The surface roughness for the contact area of the heads increased in order of XSG-alumina, SG-alumina and Co–Cr–Mo alloy. The surface roughness of the non-contact area for all kinds of heads was lower than that for the contact area [Fig. 2]. Surface profiles of the SG-alumina and XSG-alumina showed the reentrant surface while Co–Cr–Mo alloy heads showed the protrusion surface. The roundness and roughness of the Co–Cr–Mo alloy or ceramic surface and the presence or absence of hard third-body particles correlate to the amount of abrasive PE wear. When the third-body was entrapped during the clinical use, a reentrant surface might be formed on the ceramic while protrusion surface formed on the Co–Cr–Mo alloy. The differences in clinical results may be due in part to the influence of third-body particles. The ceramic becomes more resistant than Co–Cr–Mo alloy against the scratching by the entrapped abrasive contaminants because of its harder surface. From the good clinical results of more than 20 years using SG-alumina, the greater long term clinical results using XSG-alumina will be expected.

The main objective of joint arthroplasty is to improve activities of daily living of the patient. However, normal daily activities may lead to separation of articular surfaces of an artificial joint, possibly as a result of a combined impact and sliding motion. Therefore, the properties of articular surfaces define the durability of implant materials. Modification of bearing surfaces with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) increases the hydration of the surfaces and decreases the wear of the substrates. Hence, a PMPC layer can potentially cushion the impact and improve the resistance of cross-linked polyethylene (CLPE). This study aimed to explore the fatigue and wear resistance of PMPC-grafted hydrated CLPE under impact-to-wear conditions using a pin-on-disk tester.

The surfaces of a CLPE disk (3- or 6-mm thick) were modified with PMPC by photoinduced polymerization and were sterilized using gamma rays. The wear resistance of PMPC-grafted CLPE disks against a Co-Cr-Mo alloy pin was evaluated and compared to that of untreated disks. The disks were fixed to the tester with a metal plate (Ti-6Al-4V alloy) that had a central hole. The test was performed for 2 × 10⁶ cycles of repetitive impact and unidirectional sliding with the maximum load of 150 N, sliding distance of 10 mm, and frequency of 1 Hz [Fig. 1]. Gravimetric wear was determined by weighing the disks, and soak controls were used to compensate for fluid absorption. Volumetric changes in the surfaces of the disks were evaluated using a three-dimensional non-contact optical profiler.

The average gravimetric wear (mg) after 2 × 10⁶ cycles was 0.000/0.120 for CLPE (3/6 mm) and −0.073/–0.137 for PMPC-CLPE (3/6 mm). The weight gain of the PMPC-CLPE disks was due to their greater fluid absorption compared to that of the soak controls under the impact-to-wear conditions, as judged from the fact that during the load-soak in the lubricant this gain was observed for all the disks irrespectively of PMPC grafting. PMPC-grafting decreased the gravimetric wear of CLPE (p < 0.01) in the 6-mm group, whereas the thickness of the CLPE disks had no substantial effect on the wear resistance [Fig. 2]. In all cases, three-dimensional measurements detected a remarkable volumetric penetration in the impact-sliding surfaces and an extrusion of CLPE from the backside surfaces into the hole in the metal plate. Both the volumetric penetration and backside extrusion were smaller in the 6-mm group. The PMPC grafting had no discernible effect on these volumetric changes [Fig. 3]. Even after 2 × 10⁶ cycles of impact loads, mechanical fracture or delamination of the impact-sliding or backside surfaces were hardly observed in all the groups.

The results of this study revealed that: (1) PMPC-grafting of CLPE surfaces decreased the gravimetric wear irrespectively of the disk thickness; and (2) thinner CLPE increased the risk of volumetric changes, including penetration in the impact-sliding surface and extrusion of the backside surface. In conclusion, PMPC grafting can potentially improve the wear resistance of the bearing surface of biomaterials even under impact-to-wear conditions, increasing the longevity of artificial joints.

Introduction

Periprosthetic osteolysis is considered the main problem limiting the longevity and clinical success of artificial hip joints. Aiming at the reduction of the wear particles and the elimination of periprosthetic osteolysis, we have recently developed a novel articular cartilage-inspired technology for surface modification (Aquala® technology) with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC) grafting (100–150 nm in thickness) for an acetabular liner in an artificial hip joint. Our previous study on the mechanical and biological effects of PMPC revealed that the grafting decreased the production of wear particles and the bone resorptive responses. However, as well as wear-resistance, oxidation is an important indicator of the clinical performance of acetabular liners. The incorporation of the antioxidant vitamin E has been proposed recently as an alternative to post melting treatment after gamma-ray irradiation to avoid oxidation. The purpose of this study is to investigate the effects of substrate materials, vitamin E-blended cross-linked polyethylene (CLPE), on the oxidative stability and wear resistance of the PMPC-grafted CLPE liner for artificial hip joints.

Different types of highly cross-linked polyethylene (HXLPE) have been introduced widely in acetabular cups in hip prostheses to reduce the incidence of wear debris-induced osteolysis. Also, we reported that HXLPE cups with 28-mm alumina ceramic femoral head exhibited lower wear than conventional PE cups. Recently, the combination of HXLPE cup and larger diameter femoral head is used widely to prevent dislocation. In this study, we examined the wear of HXLPE with 32-mm alumina ceramic femoral head and compared it with the wear of HXLPE with 28-mm alumina ceramic femoral head.

The in vivo wear of 60 HXLPE cups (Aeonian; Kyocera Corp., Kyoto, Japan, currently Japan Medical Materials Corp., Osaka, Japan) with 28-mm alumina ceramic femoral head with clinical use for 3.1–9.1 years (mean 7.4 years) and eight HXLPE cups with 32-mm alumina ceramic femoral head used for 2.3–3.2 years (mean 2.8 years) were examined by radiographic analysis.

The early wear rate for the first year of HXLPE cups with 28-mm and 32-mm alumina ceramic femoral head were 0.24±0.10 mm/year and 0.29±0.12 mm/year respectively. There was no significant difference in both femoral head groups (p>0.05). The steady wear rate after 1 year were 0.001±0.03 mm/year and −0.03±0.10 mm/year respectively. There was no significant difference either in both femoral head groups (p>0.05).

These findings from this radiographic analysis suggest that the early wear rate in the first 1 year probably represents the creep deformation in bedding-in stage; and the steady wear rate after 1 year probably represents mainly the wear than of the creep deformation. By the radiographic analysis, HXLPE cups in both femoral head groups exhibited low steady wear rate.

In conclusion, we expect that the combination of HXLPE cup and 32-mm diameter alumina ceramic femoral head has favorable wear properties with possibility of prevention of dislocation in long-term clinical use.

In total hip arthroplasty (THA), one of concerned issues is osteolysis due to wear debris of ultra-high molecular weight polyethylene (PE) which often leads to aseptic loosening. Reduction of PE wear debris is essential to prevent osteolysis, and different bearing combination as well as improvement of the bearing material itself have been attempted. Hence alumina ceramics was introduced for THA, aiming to reduce PE wear debris. Ceramic on PE couple showed good results in clinical wear compared with metal on PE couples. Highly cross-linked PE (HXLPE) with gamma-ray or electron-beam irradiation followed by thermal treatment has also demonstrated a remarkably low wear in the previous in vitro studies. In in vivo studies, the wear of HXLPE acetabular cups against alumina ceramic femoral head was evaluated to compare with that of conventional PE cups against alumina ceramic femoral head.

The in vivo wear of 61 HXLPE cups (Aeonian; Kyocera Corp., Kyoto, Japan, currently Japan Medical Materials Corp., Osaka, Japan) against alumina ceramic femoral head of 28 mm in diameter with clinical use for 2.1–7.1 years (mean 5.6 years) and eight conventional PE cups against an alumina ceramic femoral head of 28 mm in diameter used for 18.7–23.3 years (mean 20.4 years) were examined by radiographic analysis with Vector Works 10.5. The in vivo wear of eight retrieved HXLPE cups with clinical use for 0.9–6.7 years (mean 2.9 years) and 14 retrieved conventional PE cups used for 16.0–28.0 years (mean 22.0 years) were examined by using a three-dimensional coordinate measuring machine. The worn surfaces of retrieved HXLPE and conventional PE cups were observed by a scanning electron microscope.

In the radiographic study, penetration rate of alumina head into HXLPE and conventional PE for the first 1 year were 0.24 mm/year and 0.34 mm/year respectively. One year later, the HXLPE showed significant lower penetration rate of 0.001 mm/year than the conventional PE penetration rate of 0.12 mm/year (p< 0.01). By the retrieval analysis, the mean penetration of retrieved HXLPE and conventional PE cups were 0.11 and 2.97 mm, and they were similar to the results by radiographic analysis. In the worn surface of the retrieved HXLPE cups used for around 1 year, machine marks were observed. In contrast, the worn surface of the retrieved HXLPE cups used for more than five years were smooth, and furthermore, in high magnification observation they had wear morphology different from conventional PE. These findings from this retrieval study suggest the penetration in the first 1 year detected by radiographic measurement was probably caused by creep deformation in bedding-in stage; and 1 year after, the penetration was probably caused mainly by wear.

By the radiographic analysis, HXLPE cups against alumina ceramic femoral head has a 99 % lower wear rate compared with conventional PE cups. Also, retrieved HXLPE cups against alumina ceramic femoral head exhibited lower wear compared with conventional PE cups. In conclusion, we expect that the HXLPE cup used with alumina ceramic femoral head has favorable wear properties in long-term clinical use.

A consensus on total hip arthroplasty (THA) concluded that the major remaining issues of concern included the long-term fixation of the joint replacement, osteolysis due to poluethylene (PE) wear debris which often leads to aseptic loosening. Alumina ceramics had been extensively used in medicine, and we started using the alumina ceramic for THA bearing surface in hopes to reduce the PE debris. It was because alumina ceramics is advantageous for precision machining compared with metal materials, and its hardness is higher than that of metal materials. Also, to augment cement–bone bonding, we interposed hydroxyl apatite (HA) granules at the cement–bone interface, so called “Interface Bioactive Bone Cement (IBBC) technique”. HA granules (2–3 g) were smeared on the bone surface of the acetabulum and femur just before cementing. In this study, we evaluated 19–22 years clinical results of THA with alumina ceramic head combined with PE cup fixated IBBC technique.

Total 285 joints (212 patients) were implanted by one senior surgeon from January 1986 to December 1988, and 265 joints (192 patients) were traceable. Alumina ceramic femoral head of 28 mm in diameter and acetabular cup of the conventional PE sterilized with ethylene oxide gas were used in all patients. The PE cup and stem were fixed with IBBC technique in all cases. The presence of radiolucent line, loosening and osteolysis were observed using radiograph of the traceable cases. The locations of radiolucent lines were identified according to the zones described by DeLee and Charnley for acetabular cups and the zones described by Gruen et al. for femoral stems. The in vivo wear of 21 PE acetabular cups for 19.0–21.9 years (mean 20.3 years) was measured from the latest radiographs using computer assistant technique with Vector Works 10.5 software.

Features of the clinical radiograph images of the IBBC case were classified as follows: the radiolucent line represented “gap” between the HA layer and the cement; the loosening represented “opening” between the HA layer and the cement. For the quantitative analysis, we divided the surrounding bones of the THA into several zones as done in the previous studies. The “gap” appeared in zone 4 in three joints (1.4 %), in zone 3 in two joints (0.9 %) of acetabular cup. In femoral side, in zone 1 in four joints (1.8 %) in zone 7 in one joint (0.4 %). The “opening” appeared in three acetabular cup (1.4 %). Since no opening was appeared in zone 3 or zone 4, however, no re-operation was needed. Images of osteolysis were seen one in zone 1 (0.5 %), and one in zone 2 (0.5 %) in acetabular side and two in zone 1 (0.9 %) of the femur. The mean linear wear rate of PE acetabular cups was 0.13 mm/year.

The fixation to the bone by the IBBC technique has been maintained for long term. We think that the result was brought by the biological integration between bone and HA granules. In conclusion, this study has shown satisfactory results of the cemented THA with ceramic head combined with PE cup for 19–22 years.

Aseptic loosening induced by wear debris of polyethylene (PE) is the most common cause of long-term total hip arthroplasty failure. In the previous studies, we reported that the protruding contour and surface morphology of metallic femoral head brought an increase of PE wear. Alumina ceramics is advantageous (neutral shape and smooth surface) for precision machining compared with metal materials, because hardness of ceramics is higher than that of metal materials. In this study, we measured the roundness and the roughness of retrieved alumina ceramic and metallic heads, aiming to evaluate the change of surface morphology of those heads in vivo.

Fourteen retrieved alumina ceramic femoral heads (Kyocera Corp., currently Japan Medical Materials Corp.) were examined: ten femoral heads were made of small grain-size alumina ceramic (SG-alumina; mean grain size is 3.4 um) with a diameter of 28 mm, with clinical use for 16–28 years (mean 22 years) and four femoral head was made of extra-small-grain size alumina ceramic (XSG-alumina; mean grain size is 1.3 um) with a diameter of 26 mm, with clinical use for 14–19 years (mean 16 years). Six retrieved metallic femoral heads with average clinical use for 12–28 years (mean 18 years) were examined: a diameter of from 22 to 32 mm (e.g. Zimmer Inc., Stryker Corp.) The roundness of the retrieved femoral heads was measured by a contour tracer. The surface roughness in the contact area and the non-contact area of the retrieved femoral heads was measured by a surface roughness tester.

Out-of-roundness of SG-alumina and XSG-alumina heads was 0.15 um and 0.19 um, respectively. In contrast, that of metal heads was 2.43 um, and the profiles were in wide distortion compared with both alumina heads. The surface roughness was 0.012 um in the contact area, and 0.009 um in the non-contact area of retrieved SG-alumina heads. The surface roughness in the contact area, 0.007 um, of XSG-alumina was slightly higher than that in the non-contact area, 0.003 um, and the both area of XSG-alumina represent lower value than SG-alumina, with all alumina heads having a reentrant surface profile. In contrast, the surface roughness of metallic heads was in a range of 0.003–0.053 um and several heads showed the protrusion surface profile.

In this retrieval study, the roundness and the roughness of both alumina ceramic femoral heads after long-term clinical use were low and stable compared with metallic heads. And also, the surface roughness increased in the order of XSG-alumina < SG-alumina < metallic head. The alumina ceramic femoral head showed the reentrant surface whereas the metallic head showed the protruding surface. When third-body wear occurs during the clinical use, generally reentrant form may occur on the ceramic surface whereas protrusion form may occur on the metallic surface. We have good clinical results more than 20 years using the SG-alumina, and clinical results for a long term will be expected with XSG-alumina of improved microstructure.

One of important issues of concern in total hip arthroplasty (THA) is osteolysis due to wear debris of ultra-high molecular weight polyethylene (PE), and it often leads to aseptic loosening. Reduction of PE wear debris is essential to prevent osteolysis, and different bearing interfaces as well as improvement of the bearing material itself have been attempted. Alumina ceramics as the bearing material for THA was introduced in Europe and Japan in the 1970s in aim to reduce the PE wear debris. The clinical results have proved the superiority of ceramic on PE couples to metal on PE couples in wear resistance. PE materials cross-liked by irradiation have also demonstrated a significant low wear by in vitro studies. Several types of highly cross-linked polyethylene (CLPE), with the irradiation dose of 50 to 105 kGy, have been developed and extensively used since 1998. In this study, the in vivo wear and oxidation of CLPE acetabular cup combined with ceramic femoral head were evaluated using retrieved cups.

Eight retrieved CLPE acetabular cups (Aeonian; Kyocera Corp., Kyoto, Japan, currently Japan Medical Materials Corp., Osaka, Japan) with clinical use for 3–80 months (mean 34 months) were examined. All cups were used against alumina or zirconia ceramic femoral heads. The linear wear of the retrieved CLPE cups was measured using a three-dimensional coordinate measurement machine. The worn surfaces of retrieved CLPE cups were observed by a scanning electron microscope (SEM). Oxidative degradation of the retrieved CLPE cups was expressed in terms of an oxidation index which was calculated from microscopic Fourier transformed infrared spectroscopy analysis, according to ASTM F2102.

The linear wear rate of retrieved CLPE cups was in 0.006–0.08 mm/year range, which was similar to the results reported by the previous radiographic study. In the worn surface of the CLPE cup retrieved after clinical use shorter than 39 months, machine marks were observed. In contrast, those retrieved after clinical use of 70 and 80 months were smooth. Oxidation indices of retrieved CLPE cups were: 0.12–0.37 in worn surface and 0.13–0.34 in unworn surface, respectively. There was no difference in the oxidation indices between the worn surface and unworn surface.

The retrieved CLPE acetabular cups in this study showed low and stable wear rates. The results showed a notable reduction in wear of the CLPE cups compared to that of conventional PE cups in the previous studies. And also, the oxidation indices of the retrieved CLPE cups were the same level as conventional PE cups. These findings from this retrieval study showed that there is neither progressive wear in the clinical use for 3–80 months, material failures due to wear, delamination nor cracks. The lower wear rate and smooth surface of the CLPE acetabular cup suggest the possibility of reduced wear debris from those cups articulated against the ceramic femoral head. We expect that the CLPE acetabular cup has favorable wear properties in long-term clinical use.

Different studies have shown that gamma-irradiated polyethylene generally results in degradation by oxidation. On the other hand, we clinically used ultra-high molecular weight polyethylene sterilized by gamma-irradiation of 1,000kGy dose in the air (100Mrad cross-link polyethylene) for total hip prostheses from 1970 to 1978, and excellent clinical results extending for 30 years were shown. In the present study, the wear characteristics were evaluated by hip simulator on 100Mrad cross-link polyethylene cups which were available after shelf-aging for extremely long term (about 30 years). The results are compared with those ofthe explanted cup after 30 years of clinical use as well as the cups aged by acceleration in order to review the influence of aging environments and themechanism of degradation.

The 100Mrad polyethylene cups were manufactured by Mizuho Medical Instruments in the 1970s and they have been in stock on the shelf in air-containing package or without being packed for 30 years. These cups were tested with alumina heads (36mm in diameter) by the AMTI hip-joint simulator.

The 100Mrad polyethylene cup aged for 30 years without a package showed considerable initial wear. In case of the same cup aged in an air-containing package, however, a significant reduction of wear was observed even with the presence of the oxidized surface layer. This observation agreed with the low wear of explanted 100Mrad polyethylene after 30 years of clinical use. These results suggest that wear properties of this gamma-irradiated polyethylene are significantly affected by the environmental conditions it was kept for long period of time.

According to the knee simulator test results in 1970s, the total decrease in thickness of UHMWPE tibial tray in combination with ceramic femoral component [F-Comp] was less than one tenth as that of the combination with metal [1]. These advantages led to development of total knee prosthesis [TKP] with alumina ceramics. In this study, we report the wear surface observation, the clinical wear and the oxidation of the retrieved TKP used clinically for 23 years, comparing with a metal TKP.

The retrieved TKP was implanted in 1979, and retrieved on January 9th in 2002. This TKP consisted of an alumina ceramic F-Comp and a UHMWPE tray combined with a alumina ceramic tibial component. Observations of the surface of alumina F-Comp and UHMWPE tray were carried out using SEM. Shape of UHMWPE tray was determined three-dimensionally. Comparing the result with original shape based on the product’s plan, liner wear and volumetric wear were calculated. Oxidation index was determined by Fourier transform infrared spectrophotometry.

Alumina F-Comp did not have any scratch on the surface by seeing with naked eye. UHMWPE tray had deformation and scratches obviously. The liner wear rate was 37 micrometer/year and volumetric wear rate was 18.8 mm3/year. The oxidation indexes were 0.6 in the unworn area, 1.2 in the worn area and 0.2 in the inner area.

SEM observations of the F-Comp demonstrated no scratch or pit. In contrast, many scratches were clearly observed on the UHMWPE tray. However, higher magnification observations did not demonstrate severe wear, which was shown on the wear analysis of a metallic F-Comp. Oxidation degradation is a problem to solve. However, the low wear rate and mild wear pattern demonstrate that ceramic F-Comp reduced UHMWPE wear.