The aim of this study was to determine the clinical outcomes and factors contributing to failure of transposition osteotomy of the acetabulum (TOA), a type of spherical periacetabular osteotomy, for advanced osteoarthritis secondary to hip dysplasia. We reviewed patients with Tönnis grade 2 osteoarthritis secondary to hip dysplasia who underwent TOA between November 1998 and December 2019. Patient demographic details, osteotomy-related complications, and the modified Harris Hip Score (mHHS) were obtained via medical notes review. Radiological indicators of hip dysplasia were assessed using preoperative and postoperative radiographs. The cumulative probability of TOA failure (progression to Tönnis grade 3 or conversion to total hip arthroplasty) was estimated using the Kaplan-Meier product-limited method. A multivariate Cox proportional hazards model was used to identify predictors of failure.Aims
Methods
To clarify the mid-term results of transposition osteotomy of the acetabulum (TOA), a type of spherical periacetabular osteotomy, combined with structural allograft bone grafting for severe hip dysplasia. We reviewed patients with severe hip dysplasia, defined as Severin IVb or V (lateral centre-edge angle (LCEA) < 0°), who underwent TOA with a structural bone allograft between 1998 and 2019. A medical chart review was conducted to extract demographic data, complications related to the osteotomy, and modified Harris Hip Score (mHHS). Radiological parameters of hip dysplasia were measured on pre- and postoperative radiographs. The cumulative probability of TOA failure (progression to Tönnis grade 3 or conversion to total hip arthroplasty) was estimated using the Kaplan–Meier product-limited method, and a multivariate Cox proportional hazard model was used to identify predictors for failure.Aims
Methods
The aims of this study were to validate the Forgotten Joint Score-12 (FJS-12) in the postoperative evaluation of periacetabular osteotomy (PAO), identify factors associated with joint awareness after PAO, and determine the FJS-12 threshold for patient-acceptable symptom state (PASS). Data from 686 patients (882 hips) with hip dysplasia who underwent transposition osteotomy of the acetabulum, a type of PAO, between 1998 and 2019 were reviewed. After screening the study included 442 patients (582 hips; response rate, 78%). Patients who completed a study questionnaire consisting of the visual analogue scale (VAS) for pain and satisfaction, FJS-12, and Hip disability and Osteoarthritis Outcome Score (HOOS) were included. The ceiling effects, internal consistency, convergent validity, and PASS thresholds of FJS-12 were investigated.Aims
Methods
Biofilm formation is intrinsic to prosthetic joint infection (PJI). In the current study, we evaluated the effects of silver-containing hydroxyapatite (Ag-HA) coating and vancomycin (VCM) on methicillin-resistant Pure titanium discs (Ti discs), Ti discs coated with HA (HA discs), and 3% Ag-HA discs developed using a thermal spraying were inoculated with MRSA suspensions containing a mean in vitro 4.3 (SD 0.8) x 106 or 43.0 (SD 8.4) x 105 colony-forming units (CFUs). Immediately after MRSA inoculation, sterile phosphate-buffered saline or VCM (20 µg/ml) was added, and the discs were incubated for 24 hours at 37°C. Viable cell counting, 3D confocal laser scanning microscopy with Airyscan, and scanning electron microscopy were then performed. HA discs and Ag HA discs were implanted subcutaneously in vivo in the dorsum of rats, and MRSA suspensions containing a mean in vivo 7.2 (SD 0.4) x 106 or 72.0 (SD 4.2) x 105 CFUs were inoculated on the discs. VCM was injected subcutaneously daily every 12 hours followed by viable cell counting.Aims
Methods
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.
Alumina and zirconia have been extensively used for orthopedic implants, such as hip and knee joint replacements. In 1982, Dr Hironobu Oonishi and Kyocera Corp. put the world’s first ceramic knee component, KOM, to practical use. This ceramic knee component shows excellent clinical results for long-time use. Now, the ceramic material of the knee component is changed from the alumina to the zirconia, and over 5000 ceramic components have been used in Japan so far. The 3 mol% yttria stabilized polycrystalline zirconia (3Y-TZP) has been used as surgical grade zirconia. The 3Y-TZP possesses higher fracture strength and toughness as compared to monolithic alumina. However, it is generally known that spontaneous transformation may also occur at relatively low temperatures in hydrothermal environment as in the case of human body for the 3Y-TZP. Therefore, there is a concern of the degradation of mechanical and wear properties as a consequence of the transformation (low temperature degradation). Our previous studies confirmed that low temperature degradation can be prevented by optimizing sintering temperature and adopting a Hot Isostatic Press process. In this study, we evaluated the effects of surface nature of ceramic material and heat treatment. Since grinding and polishing of the ceramic implants (e.g. femoral heads) might induce phase transformation, residual stress and microcracks, it is needed to examine the validity of the manufacturing process. At first, the 3Y-TZP samples with grinded (#400) and mirror polished surfaces were prepared and exposed in saturated vapor in an autoclave at 121°C for 150 h (aging test). Some of the samples were subjected to a heat treatment and then to aging test. Before and after aging test, change in crystal structure was evaluated by X-ray diffraction. Then, for evaluation of the aging effects for microscopic area of the ceramic, a Vickers indentation was introduced on the surface before the aging test. Changes in crystal structure and residual stress were evaluated by a Raman spectroscopic technique. In the results of the aging test, it was found that the degree of the increase in monoclinic fraction of both grinded and polished surfaces was lower in the samples with heat treatment than in those without heat treatment. These results indicate that the phase stability of the 3Y-TZP was improved by the heat treatment after machining. Around the indentation, circular-like deformation zone and cracks extending from the four corners of the indentation were observed. After the aging test, the transformed area gradually spread towards neighborhood regions depending on the aging time. Besides, a distinct progress of phase transformation at around the crack was also observed. On the other hand, in the samples subjected to the heat treatment, no transformed area was observed around the indentation. These results suggest that low temperature degradation could be prevented by the heat treatment after the machining. The residual stress fields induced in phase-transformed areas increased during aging test, and heat treatment after the machining was also able to prevent phase transformation even if surface damages, such as indentation or machining, were introduced on the samples.
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.
The Bisurface knee prosthesis (BP) has a posterior stabilising cam (ball-and-socket joint) in the mid-posterior region of the femorotibial joint in an attempt to improve the range of movement. Based on an in vitro weight-bearing study contact areas of the Insall/Burstein 2 (IB2) and the BP knee were compared using pressure-sensitive films. The stability afforded by the cam was evaluated by means of dislocation distances in the vertical and horizontal planes. Significant adverse anterior translation in mid-flexion was not observed with the BP knee since the cam was effective above 60° of flexion. At flexion of 60° or more, the total contact areas were larger, as the cam represented a weight-bearing surface. The dislocation distances for the BP knee compared favourably with those for the IB2 knee. We conclude that the cam of the BP knee allows good movement, stability and wear.