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.

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.

Development of artificial cartilage has been one of the future goals in the field of orthopaedic surgery. A few investigators have applied polyvinyl-alcohol hydrogel (single-network) to develop the artificial cartilage. However, it could not be applicable for clinical use due to insufficiency of the strength, the toughness, and the friction properties. The authors have conducted a fundamental study to apply a novel double-network (DN) hydrogel to develop the artificial cartilage. This hydrogel is composed of two independently crosslinked hydrophilic networks of poly-2-acrylamido-2-methyl-propanesulfonic acid (PAMPS) and poly-N,N′-Dimetyl acrylamide (PDMAAm) that are physically entangled with each other. This study evaluated the in vivo influence of a PAMPS/PDMAAm DN hydrogel on counterface cartilage in rabbit knee joints and its ex-vivo frictional properties on normal cartilage.

In the first experiment, the DN gel was implanted in a surgically created defect in the femoral trochlea of rabbit knee joints and the left knee was used as the control.

Evaluations using a confocal laser scanning microscopy demonstrated that the DN gel did not affect the surface microstructure (surface roughness, the number of small pits) of the counterface cartilage in vivo at 4 and 12 weeks. The histology also showed the DN gel had no pathological damage on the cartilage matrices and cells at 4 weeks.

However, 2 of the 5 DN gel-implanted knees showed mild irregularity on the counterface cartilage surface at 12 weeks. In the second experiment, the friction property between the normal and artificial cartilage was determined using a joint simulator apparatus. The ex-vivo mean friction coefficient of the DN gel to normal cartilage was 0.029, while that of the normal-to-normal cartilage articulation was 0.188. The coefficient of the DN gel-to-normal cartilage articulation was significantly lower that of the normal-to-normal cartilage articulation (p< 0.0001). This study suggested that the PAMPS/PDMAAm DN gel has very low friction coefficient on normal cartilage and has no significant detrimental effects on counterface cartilage in vivo, and can be a promising material to develop the artificial cartilage.

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.