Aims . The primary aim of this independent prospective randomised trial was to compare serum metal ion levels for ceramic-on-metal (CoM) and metal-on-metal (MoM) bearing surfaces in total hip arthroplasty (THA). Our one-year results demonstrated elevation in metal ion levels above baseline with no significant difference between the CoM and MoM groups. This paper reviews the five-year data. Patients and Methods. The implants used in each patient differed only in respect to the type of femoral head (ceramic or metal). At five-year follow-up of the 83 enrolled patients, data from 67 (36 CoM, 31 MoM) was available for comparison. Results. The mean serum cobalt (Co) and chromium (Cr) ion levels remained above baseline in both groups (CoM: Co 1.16 μg/l (0.41 to 14.67), Cr 1.05 μg/l (0.16 to 12.58); MoM: Co 2.93 μg/l (0.35 to 30.29), Cr 1.85 μg/l (0.36 to 17.00)) but the increase was significantly less in the CoM cohort (Co difference p = 0.001, Cr difference p = 0.002). These medium-term results, coupled with lower revision rates from national joint registries, suggest that the performance of CoM THA may be superior to that of MoM. . Conclusion. While both bearing combinations have since been withdrawn these results provide useful information for planning clinical surveillance of CoM THAs and warrants continued monitoring. Cite this article: Bone Joint J 2017;99-B:1298–1303

In a double-blinded randomised controlled trial, 83 patients with primary osteoarthritis of the hip received either a ceramic-on-metal (CoM) or metal-on-metal (MoM) total hip replacement (THR). The implants differed only in the bearing surfaces used. The serum levels of cobalt and chromium and functional outcome scores were compared pre-operatively and at six and 12 months post-operatively. Data were available for 41 CoM and 36 MoM THRs (four patients were lost to follow-up, two received incorrect implants). The baseline characteristics of both cohorts were similar. Femoral head size measured 36 mm in all but two patients who had 28 mm heads. The mean serum cobalt and chromium levels increased in both groups, with no difference noted between groups at six months (cobalt p = 0.67, chromium p = 0.87) and 12 months (cobalt p = 0.76, chromium p = 0.76) post-operatively. Similarly, the mean Oxford hip scores, Western Ontario and McMaster Universities Osteoarthritis index and University of California, Los Angeles activity scores showed comparable improvement at 12 months. Our findings indicate that CoM and MoM couplings are associated with an equivalent increase in serum cobalt and chromium levels, and comparable functional outcome scores at six and 12-months follow-up.

Aims. In 2015, we published the results of our ceramic-on-metal (CoM) total hip arthroplasties (THAs) performed between October 2007 and July 2009 with a mean follow-up of 34 months (23 to 45) and a revision rate of 3.1%. The aim of this paper is to present the longer-term outcomes. Methods. A total of 264 patients were reviewed at a mean of 5.8 years (4.6 to 7.2) and 10.1 years (9.2 to 10.6) to determine revision rate, pain, outcome scores, radiological analysis, and blood ion levels. Those who were unwilling or unable to travel were contacted by telephone. Results. The all-cause revision rate at six years was 3.1% (eight THAs), increasing to 8.8% (18 THAs) at ten years. Of these, there were four and then seven bearing-related revisions at six and ten years, respectively. There was a statistically significant deterioration in the visual analogue scale pain score and Oxford Hip Score (OHS) between six and ten years. There were 18 CoM THAs in 17 patients who had a cobalt or chromium level over 4 ppb and ten CoM THAs in nine patients who had a cobalt or chromium level higher than 7 ppb with a statistically significant increase in chromium levels only between the two timepoints. Overall, 84 stems (39.1%) had significant radiolucent lines at ten years compared to 65 (25.5%) at six years. Conclusion. When compared to the original review, there has been a significant deterioration in pain score, OHS, radiograph appearance, and, most critically, survival has fallen to 91.2%, which does not meet the Orthopaedic Data Evaluation Panel (ODEP) 10 A* 95% threshold. Although this bearing is no longer on the market, 2.5% were bearing-related revisions, which have relevance to the discussion around modular dual-mobility implants that have a similar metal interface

A randomised prospective study of four bearing surfaces in hip replacements is being conducted. The primary objective is to identify the best long term bearing surf ace clinically and radiographically, and metal ion levels have been measured in all cases. Patients have been randomised to the four bearing surfaces viz. Ceramic-on-XLinked Polyethelene, Ceramic-on-Ceramic, Metal-on-Metal and Ceramic-on-Metal. Pre-operative blood samples and follow-up blood samples for metal ion analysis using ICP-MS method have been taken in all patients. As at February 2008 187 patients have been recruited, and metal ion levels at one year are available in 52 patients. Metal ion levels are not increased with Ceramic-on-XLPE or Ceramic-on-Ceramic bearings. At one year follow-up the metal ion levels in Ceramic-on–Metal bearings is half that of Metal-on-Metal bearings using mean levels, and one third using median levels. Of note is that chromium levels in Ceramic-on-Metal bearings is the least elevated. Due to the laboratory evidence that ceramic-on-metal bearings have the best surf ace wear characteristics with no head stripe wear on a ceramic head, and the laboratory and clinic al evidence of lower metal ion levels, Ceramic-on-Metal hip replacements could be one of the bearing surfaces of the future

This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition

Osteolysis is one of a major cause of failure that affect long term survival rate in THA. Hard-on-hard bearing surface were developed to reduce wear and osteolysis, such as ceramic-on-ceramic which is the lowest wear rate was introduced but it still has squeaking and ceramic fracture. Metal-on-metal bearing surface significantly reduce wear rate but it still release metal ion which affect local tissue reaction. Then ceramic-on-metal is another choice of bearing with combine the advantage of reduce wear rate, metal ion release, no stripe wear, no squeaking and no ceramic fracture. However after clinical use ALTRs may occur and disturb the longevity of THA. During January 2009 to December 2009 we performed 98 THR with the same femoral stem and acetabular cup with difference bearing which were 87 cases of metal on cross-linked PE, 8 cases of ceramic on metal and 5 cases of metal on metal. Routinely postoperative care were done with clinical evaluation, plain x-rays and Harris hip score. After 5 years follow up there are clinical problems in ceramic on metal THA with decrease clinical score and progressive osteolysis in radiographic finding in 2 cases then we investigated to find the cause of this problem and revise the components. We preformed magnetic resonance imaging and collect blood sample for ESR, CRP and Cobalt and Chromium level. We revised 2 cases of ceramic on metal THA, during surgery we collected tissue for bacterial and AFB and histopathology. All retrieval components were studied for wear pattern. First patient have thigh pain and progressive osteolysis after year 4. th. of follow up. She had normal ESR and CRP with high level of cobalt and chromium level. We revised both components and tissue histopathology showed metallosis with chronic inflammation. Another patient had failure due to ALTRs with mixed solid-cystic mass at trochanteric bursa but component is stable then only bearing surface were change. Wear pattern at femoral head was in weight bearing area with corresponding to apical center wear of metal liner. Our study showed that only in group of ceramic-on-metal THA that have 5 years follow up have early reoperation due to osteolysis and tissue reaction. We routinely stop to use this bearing since 2010. But we have small number of cases in our study to conclude that is bearing are not suitable for clinical usage

The search for the ideal bearing surfaces to be used in Total Hip Replacement continues. The current “best” materials are felt to be various combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best combination with the lowest side effect profile. In February 2004 a prospective randomised trial on different bearing surfaces was started. The combinations selected were ceramic-on-cross-linked polyethylene, ceramic-on-ceramic, metal-on-metal and ceramic-on-metal. Institutional ethics clearance was obtained. In all patients uncemented femoral stems are used, with an uncemented porocoated acetabular shell. A uniform 28mm femoral head size was selected. Blood samples have been taken to measure the metal ion concentrations in all patients. These are measured pre operatively, and repeated at follow up visits at 3 months and 1 year, with further follow up at 3,5 and 10 years post operatively. Whole blood ion levels are measured using a graphite furnace atomic absorption spectrometer. Between February 2004 and April 2006 one hundred and ten hips have undergone total hip replacement. There are 105 patients (5 bilateral). 40% are males and 60% female. The average age at operation is 52 years (17 to 72). 49% hips are left and 51% right. Follow up includes blood samples and the Harris Hip Score. Complications to date have been surgeon related, with three femoral components needing early revision for technical reasons. This has not affected the bearing surfaces. Radiological and clinical assessment shows no difference between the different bearing surface groups. Post operative whole blood metal ion levels are compared to the patient’s pre operative level. To date there is no increase in the metal ion levels for the ceramic-on-cross linked polyethylene and ceramic-on-ceramic articulations. The ceramic-on-metal group is providing moderately raised metal ion levels, and the highest metal ion levels are in the metal-on-metal articulation group. At one year, the ceramic-on-metal group demonstrates a drop to close to pre-operative levels and these are still significantly lower than the metal-on-metal group. This confirms laboratory studies on the ceramic-on-metal articulation, which demonstrate significantly lower wear than comparable metal-on-metal articulations. The high level of metal ions in the latter groups has always been of concern. This study demonstrates a lower blood level of metal ions in the ceramic-on-metal group. If the in vivo wear rate in this group continues to replicate the laboratory wear studies, this articulation becomes a very attractive bearing surface in younger active patients, and may well become a bearing surface of choice in the future

The search for the ideal bearing surface in Total Hip Replacements continues. The current ‘best’ materials are felt to be combinations of metal, ceramics and cross-linked polyethylene. Laboratory studies suggest that ceramic-on-metal articulations may provide distinct advantages. This study aims to identify the best bearing surface combination with the lowest adverse side effect profile. Between February 2004 and September 2007, 164 hips were replaced in 142 patients. 39% were male and 69% were female. The average age at surgery was 53 years (17-72 years). Follow-up assessment included radiographs, the Harris Hip Score and whole blood samples for metal ion levels. Complications to date included 3 hips which needed femoral revision because of surgery related factors, and 3 cases of sepsis of which 1 settled and 2 needed revision. One hip needed revision of head and liner to a larger bearing size for recurrent dislocations, and is no longer being followed up for blood metal ions. Post-operative whole blood metal ion levels were compared to pre-operative levels to determine the increase or decrease in metal ion levels. There were no changes in those patients with ceramic-on-ceramic and ceramic-on-polyethylene articulations. Moderately raised whole blood metal ion levels were noted at 3 months in the ceramic-on-metal group, while the metal-on-metal group show the greatest increase. This study agrees with laboratory bearing surface wear studies demonstrating lower wear rates in the ceramic-on-metal group compared to the metal-on-metal group. With concerns related to high blood metal ion levels in metal-on-metal articulations, ceramic-on-metal bearing surfaces may well become a bearing surface of choice in the future, but progress needs to be monitored in the longer term

Introduction:. Whole blood metal ion level and clinical outcomes of ceramic-on-metal bearing were comparable to ceramic-on-ceramic THA in this prospective randomized controlled trial. Methods:. We randomized 150 consecutive THA cases at one institution into two groups: Group I and Group II. Group I, 75 cases, received a THA using ceramic-on-metal couplings and Group II, 75 cases, received ceramic-on-ceramic bearing THA. The implant differed only in the bearing surfaces used. We compared the serum levels of cobalt (Co) and chromium (Cr) and functional outcome scores preoperatively, and at 2, 6, and 12 months postoperatively. Results:. The demographics and preoperative Co and Cr levels were similar between the groups. Femoral head size measured 32 and 36 mm and the proportion of each size was similar in both groups. The mean serum cobalt and chromium levels increased significantly at 2 months in Group I (Co p = 0.02, Cr p = 0.04), but no differences noted between groups at 6 and 12 months (Co p > 0.05, Cr p > 0.05). The mean WOMAC hip scores showed comparable improvements at 12 months with no difference between groups. No ceramic fracture has occurred during follow-up period. Discussion & Conclusion:. CoM bearing THA has showed the metal ion levels and the clinical results comparable to CoC couples except for the relatively high metal ion in running-in period

Background. Hard-on-hard bearings showed advantages of reduction of wear rates, osteolysis and aseptic loosening in total hip arthroplasty (THA). A new combination of ceramic-on-metal (COM) was developed to compensate the disadvantages of MOM and COC. COM showed good short-term results in vitro and in vivo studies. There was no report of stripe wear and metal ion level elevation. Our study was designed to evaluate the wear pattern of this bearing in early loosening THA. Methods. During January 2009 to December 2010, 121 primary THAs were performed at our institution by single-surgeon, using the same acetabular component and same uncemented femoral stem with a 32-mm modular head. All patients received the information of the bearing couples and made their own decision to choose one of the following bearings: COM, MOP and MOM. The functional outcomes (Harris Hip Score), Serum Co and Cr levels and survival rates were compared between groups at 5 years. The retrievals were tested by optical microscopy and Raman spectroscopy to evaluate the wear pattern in the cases those need revision. Results. At the follow-up 5 years ago, 2 in 10 patients of the COM group received revision due to bearing related complications and loosening although MOP and MOM groups have good clinical follow-up without revision. Metal ion levels were higher in the revision cases. The retrieval analyses revealed metal transfer at weight-bearing area of ceramic femoral head and large wear located on the center of acetabular liner. Spectral shift and broadening of Raman bands demonstrated incorporation of metal ions into the ceramic lattices. Conclusion. Wear pattern in COM was the same as MOM. Severe metal contamination at the ceramic surface might be affected from frictional heating. While the actual causes and contributing factors of high failure rate in COM were not clearly identified, it is important to take precautions in using COM THA

Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings. This has been attributed to reduced corrosive and adhesive wear, and differential hardness. The study assessed the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and CoCrMo alloy. Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. Testing was conducted in calf-serum for 2-million cycles. A standard simulator cycle was adapted, the head sub-luxed in the swing-phase forcing the head onto the cup rim at heel strike. The overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The COM concept allows thin metal shells to be used with larger ceramic heads and protects against ceramic liner chipping. COM bearings are undergoing clinical trials, early data suggests reduced metal ion release in patients compared to metal-on-metal

INTRODUCTION. Ceramic-on-metal hip replacements (COM, where the head is a Biolox Delta ceramic and liner is Co Cr alloy), have demonstrated reduced wear under standard conditions in vitro compared to metal-on-metal (MOM) [1]. Early clinical results are also encouraging [2]. Recently concerns have been raised regarding the poor clinical performance of MOM hip resurfacings [3], particularly when cups are steeply inclined. Laboratory hip simulator testing has been used to replicate edge loading, also demonstrating elevated wear [4]. Therefore, a range of conditions to replicate sub-optimal use clinically to better predict in vivo performance should be used. The aim of this study was to compare the wear rates of MOM and COM under adverse edge loading conditions in an in vitro hip simulator test. METHODS. Ceramic-on-metal (n=3) and metal-on-metal (n=3) 36mm hip prostheses (supplied by DePuy International Ltd, UK) were tested in the Leeds Physiological Anatomical Hip Joint Simulator. Liners were mounted to provide a clinical angle of 45o, and stems positioned anatomically. A simplified gait cycle and microseparation was applied as previously described [5] for two million cycles in 25% new born calf serum. Gravimetric analysis was completed every million cycles and wear volumes calculated. RESULTS. The overall mean volumetric wear rate of COM bearings was 0.36 ± 0.55mm3 per million cycles, this was significantly less than the MOM bearing wear (1.32 ± 0.91mm3 per million cycles). For both COM and MOM bearings wear under these edge loading conditions was significantly greater if compared to previously reported wear under standard conditions [1]. DISCUSSION. The reduced wear of COM has been attributed to the differential hardness decreasing adhesive wear and reduced corrosive wear [6]. Wear under the harsh edge-loading conditions in this study is also reported to be significantly less in COM bearings compared to MOM. In MOM bearings in edge contact conditions, the wear zone becomes starved of lubrication, this elevates wear and increases damage at the edge of the cup. In COM bearings the harder head does not become damaged when there is lubricant starvation and hence wear does not accelerate in the same way. In conclusion, COM bearings show reduced wear compared to MOM bearings under standard and adverse conditions and there is some early evidence to support this finding clinically. ACKNOWLEDGEMENTS. Supported by DePuy International Ltd. SW is supported by a Royal Academy of Engineering/EPSRC (UK) fellowship

Ceramic-on-metal (ceramic head and metal liner, COM) hip replacements have shown reduced wear in comparison to metal-on-metal (MOM) bearings (Firkins et al., 1999). This has been attributed to a reduction in corrosive wear, differential hardness and a reduction in adhesive wear. In a clinical report on the use of a metal-on-ceramic hip replacement (Valenti et al., 2007) which consisted of a stainless steel head and alumina ceramic insert at revision 6-months post-op massive metallosis and macroscopic wear was observed. The aim of this study was to assess the performance of ceramic and metal bearings in different configurations under adverse conditions, ceramic heads on metal liners (COM) were compared to metal heads on ceramic inserts (MOC), with head on cup rim loading under micro-separation hip joint simulation. Components used were made of zirconia-platelet toughened alumina (Biolox Delta) and high carbon (0.2wt%) CoCrMo alloy (DePuy International Ltd, UK). Hip simulator testing applied a twin-peak loading cycle and walking motions with the prosthesis in the anatomical position. The lubricant (25% calf-serum) was changed every 0.33Mc, wear was measured gravimetrically. Testing was conducted for 2-million cycles, a standard simulator cycle was adapted so the head subluxed in the swing phase forcing the head onto the cup rim at heel strike (Williams et al., 2006). The total overall mean wear rate for the MOC bearings (0.71±0.30mm3/Mc) was significantly higher than the wear rate for the COM bearings (0.09±0.025mm3/Mc). The contact of the head against the rim of the cup at heel strike caused deep stripe wear on the metallic heads of the MOC bearings. This region on the head is exposed to high stress conditions and susceptible to damage in edge contact, the effect of this is increased when the cup is a harder material than the head. The wear of a metal-on-metal (MOM) couple under similar conditions was almost two-fold greater than the MOC couple (1.58mm3/Mc, Williams et al., 2006) providing further evidence of the reduced wear with COM in comparison to MOM. The explant described Valenti et al. included a stainless steel head, this is a softer material compared to CoCr, and wears at a higher level. It can be postulated that the wear under adverse conditions would be further increased. The COM concept can provide increased design flexibility; thin metal shells can be used with larger ceramic heads. Additionally the design protects against ceramic liner chipping. COM bearings are currently undergoing clinical trials, early data suggests reduced metal ion release in patients with COM bearings compared to metal-on-metal (Williams et al., 2007)

Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent introduction. As such, survivorship rates from independent centres alongside explant analysis are rare. The early experience with this novel ceramic-on-metal (CoM) bearing couple is reported. Methods and Materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine. The roughness of the articulating surfaces was measured with a non-contact profilometer. Results. In 54 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34-87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm3 respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The very high early failure rate using COM is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons need to be aware of this new mechanism of failure which is associated with low metal ions

Introduction. Total hip prostheses which use a ceramic head within a metal liner are a relatively recent innovation. As such, survivorship rates from independent centres alongside explant analysis are rare. The early clinical experience with this novel ceramic-on-metal (CoM) bearing couple is reported alongside explant analysis of failed devices. Methods and materials. All CoM hips implanted between 2008 and 2009 at a single hospital by a single surgeon were reviewed. Radiographs were analysed using EBRA software to determine acetabular cup inclination and anteversion angles. Blood metal ion concentrations were measured using inductively coupled plasma mass spectroscopy (ICPMS). Explants were measured for bearing surface and taper wear using a high precision co-ordinate measuring machine (Mitutoyo Legex 322, manufacturer's claimed accuracy 0.8µm). The roughness of the articulating surfaces of heads and liners was measured with a non-contact profilometer (ZYGO NewView 5000, 1nm resolution). Results. In 56 patients 56 CoM hips were implanted. Mean (range) age was 64 years (34–87). There were 41 females and 15 males. Patients were followed-up for a mean of 1.5 years. Three hips were revised at mean of 1.2 years (2 female, 1 male) with a further 3 listed for revision under 1.5 years giving an overall failure rate of 10.7%. All these patients reported with pain. X-rays of failed devices showed a characteristic pattern of femoral stem loosening. Serum cobalt and chromium were less than 2 micrograms/L. Explant analysis of the three revised hips showed wear at the liner rim in each case. In two of these cases the wear extended completely around the circumference. The wear volumes were 4.1, 2.0 and 2.3mm. 3. respectively. The ceramic heads were unworn but some transfer of metal could be seen visually. There was no significant wear or deformation at the taper junctions. Typical ceramic head roughness values were 3nm Ra and so most of the surface area of the heads remained in a pristine condition. Discussion. The high early failure rate using a COM articulation is concerning. Explant analysis suggests equatorial contacts with propagation of high frictional forces distally. These forces may have caused early loosening of the femoral stems. Orthopaedic surgeons and bioengineers need to be aware of this new mechanism of failure in this novel biomaterial coupling which is associated with low metal ions

Background. Recent clinical studies have suggested that systemic metal ion levels are significantly elevated at midterm follow-up after ceramic-on-metal (COM) bearing. However, it is not clear whether there is a correlation between patient- and surgical-related factors including the lifestyle and elevated levels of serum metal ions following COM total hip arthroplsty (THA). Material and Methods. Two hundred and one patients (234 hips) including 121 COM patients (140 hips) and 80 non-COM patients (94 hips) were enrolled in accordance with the inclusion criteria. The patients were divided into three groups based on the type of surgical bearings used. The Harris Hip Score (HHS), University of California, Los Angeles (UCLA) activity scale score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score were measured, and radiographs were obtained for the analysis. Serum metal ion levels of cobalt and chromium were measured using a high-resolution inductively coupled plasma mass spectrometry. Patient- and surgical-related factors were analyzed to determine which group of patients is at a high risk of metal ion-related problems. Results. Significantly higher serum levels of Co and Cr were detected in the serum of the COM THA group (Co: 1.86±4.0 µg/L, range: 0.30 to 34.20 µg/L; Cr: 1.81±2.87 µg/L, range: 0.10 to 27.80 µg/L) than in the serum of the non-COM THA group (Co: 0.27±0.14 µg/L, range: 0.15 to 0.90 µg/L; Cr: 0.19±0.25 µg/L, range; 0.10 to 2.30 µg/L) (p<0.001). The HHS in the COM group was significantly better than that in the non-COM group (p=0.013). The total ROM of the THAs was significantly greater in the 36-mm COM THA group (272.7°, range: 200°–345°) than in the non-COM group (248.5°, range: 135°–300°) (p<0.001). No radiolucency, osteolysis, or loosening was found during the follow-up radiographic examination. The serum Co levels of patients who achieved the squatting position were significantly higher than those of patients who could not squat (Co: p=0.033; Cr: p=0.074). The serum Co and Cr levels of patients who achieved the kneeling position were significantly higher than those of patients who could not kneel (Co: p=0.049; Cr: p=0.031). There was no significant difference between the two groups in the cross-legged sitting position. The metal ion levels of the COM THA group correlated with the total ROM (Co: p=0.0293; Cr: p=0.0399), and those of the patients who were capable of squatting and kneeling were significantly higher than those of the patients who were unable (p<0.05). However, age, BMI, acetabular cup position and patient activity did not show significant correlations with the serum metal ion levels. Conclusions. Patients who underwent a 36-mm COM THA had good clinical outcomes with an excellent hip function at the short and midterm follow-up intervals. However, high levels of metal ions were detected in the serum of COM THA patients. We found that COM THA patients who were capable of greater ROMs, squatting, and kneeling are at risk of metal ion-related problems

Introduction. Osteolysis and aseptic loosening in total hip replacement (THR) is often associated with polyethylene (PE) wear. This caused interest in alternative bearing surfaces. Since the mid nineties, research focused on hard-hard bearings like metal-on-metal (MOM) or ceramic-on-ceramic (COC). However, concerns remain about biological reactions to metallic wear debris or failure of the ceramic components. A new approach to reduce wear with a minimized risk of failure may be the use of a metallic cup in combination with a ceramic head, the so called ceramic-on-metal bearing (COM). The aim of this study was to estimate the wear behaviour at an early stage of this COM bearing type in comparison to COC bearings using a hip simulator. Material and Methods. Simulator studies were carried out on a single station hip simulator (MTS 858 Mini Bionix II, Eden Prairie, USA) in accordance to ISO 14242-1. Bovine serum was used as the test medium. Four COM and four COC bearings were used, both 36mm in diameter. The heads were made of a mixed-oxid ceramic (Biolox Delta(r)) paired with a high carbon wrought CoCrMo cup in the COM group whereas both components were made of Biolox Delta(r) in the COC group. Simulation was run to a total of 2.4×10. 6. cycles. Wear measurements were performed in intervals of 0.2x10. 6. cycles using a gravimetric method (Sartorius Genius ME235S, measuring solution: 15 μg, Sartorius, Göttingen, Germany). Results. Wear of the COM and COC pairings is shown in Figure 1. During the first 200,000 cycles a mean wear rate of 0.16mm. 3. /10. 6. cycles was found followed by a decreased wear rate of 0.04mm. 3. /10. 6. cycles for the COC bearings. The overall wear ranged from 0.08mm. 3. to 0.17mm. 3. , with a mean of 0.12 mm. 3. There was found a high variability in the wear progression between the four COM implants (Figure 1). A mean wear rate of 0.13mm. 3. /10. 6. cycles was determined during the first 200,000 cycles followed by a decreased wear rate of 0.05mm. 3. /10. 6. cycles. The overall wear of the COM implants ranged from 0.02mm. 3. to 0.21mm. 3. , with a mean of 0.13 mm. 3. All ceramic heads from the COM bearings showed metallic material transfer in form of stripes whereas no visible wear traces were found on the COC heads. Discussion and Conclusion. The COM implants showed very low wear levels that were similar to the COC bearings and far below wear levels of conventional MOM bearings. However, there was a spreading up to the thirteen fold between lowest and highest wear volume of the COM at the end of the study. Concerning COM implants such high variability was also seen by other investigators. The simulator conditions are highly reproducible (as seen for the COC bearings). Considering the high variations in patients demand, the influence of patient related activity parameters should be further investigated in terms of wear. Moreover, this study was performed without implementing subluxation, impingement or malalignment which might also increase wear. These effects together with the influence of third body wear needs to be further considered

Ceramic-on-metal (COM) bearings have shown reduced wear and friction compared with metal-on-metal (MOM) bearings in-vitro. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces, improved lubrication and differential hardness reducing adhesive wear. Clinical studies have also shown reduced metal ion levels in-vivo compared with MOM bearings. The aim of this study was to examine two explanted COM bearings (one head and cup, one head only), and to assess the effect of in-vivo changes on the wear performance of the COM bearings by comparing the wear of the explanted bearings with three new COM implants in a hip wear simulator. Two 28mm diameter COM bearings were provided for analysis. These were visually examined and surface profilometry was performed using a 2-D contacting profilometer (Form Talysurf, Taylor Hobson, UK). Scanning electron microscopy was used to image the regions of transfer on the ceramic heads, and EDX to assess the transfer composition (Philips XL30 ESEM). Hip simulator testing was conducted for 2 million cycles (Mc) comparing the explanted bearings with three new 28mm COM bearings. Tests were performed in a Prosim simulator (SimSol, UK), which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of − 15 to 30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted in the anatomical position. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide and was changed approximately every 0.33Mc. Wear was measured gravimetrically at 0.5, 1 and 2 Mc. Regions of material transfer, identified on both ceramic explant heads, were shown to be CoCr material by EDX analysis, suggesting metallic transfer from the metal cup. Profilometry traces across metallic transfer showed comparable surface roughness measurements compared to unworn material. The overall mean wear rate for the new COM bearings at 2Mc was 0.047 ± 0.06mm3/Mc. The mean wear rate for the explanted head articulated with a new cup was slightly lower at 0.034mm3/Mc. The mean wear rate for the explanted head and cup was highest at 0.15mm3/Mc. It was noted that the explanted head/cup had higher bedding in wear compared with the other bearings, but still significantly less than a new MOM bearing (mean bedding-in wear rate 2.03 ± 2.59 mm3/Mc). The steady-state wear was comparable with the new bearings. As the orientation of these implants in-vivo was unknown, it is proposed that the elevated wear during bedding-in of the explanted head/cup bearing may be due to the alignment of the components. The wear rates of the explanted ceramic head against a new cup were comparable with the new bearings, suggesting that the presence of metallic transfer on the ceramic head does not adversely affect the wear behaviour of COM bearings

Hip simulator studies with ceramic-on-metal (COM) predicted less wear than metal-on-metal (MOM: Isaac. 2009). While clinical evidence is scant, two COM case reports described pseudotumors with adverse cup positioning (Deshmukh 2012, Koper 2014). It would appear that our Korean case report is the first to describe pseudotumor formation in well-positioned COM arthroplasty and including detailed failure analysis. A 50-year old female (active salesperson) had bilateral avascular necrosis of her femoral heads. A left metal-on-polyethylene (MPE) hip was performed at outside institution in 2003. At our 3-yrs evaluation, radiographs showed well-functioning MPE hip. Five years later she complained of gradual left-hip pain (2011). Radiographs and CT scan demonstrated wear, osteolysis and loosening of both components. The revision in 2011 was by COM (Fig. 1), using S-ROM stem/sleeve, 36mm ceramic head (Biolox-delta), a CoCr liner and 54mm shell (Pinnacle: Depuy Inc). Cup inclination and anteversion were considered appropriate at 45° and 20° respectively; femoral anteversion of 15° was also appropriate. At 1-yr follow-up patient complained of mild discomfort in left COM hip (2012). Range of motion was painless and normal. Examination revealed a soft, non-tender swelling (2×3cm) in left inguinal region with no inflammation and radiographs were normal (Fig. 1a). One month later the patient complained of left hip pain, the previously noted swelling had increased in size, and she started to limp. Radiographs showed cup migration with increased inclination. CT scans showed a circumscribed lesion extending into iliopsoas region (Fig 2). Serum cobalt and chromium levels were high at 2.4 and 22.5µg/ L, respectively. At revision the pseudotumor and surrounding inflamed synovium was excised. The cystic soft-tissue swelling (stained black) extended into the joint (Fig. 2a). The ceramic head showed a large “black stripe” across the dome (Fig 2b). The cup was loose while the femoral stem was well fixed. Operative cultures of soft tissues and joint fluid were negative for infection while histopathology was consistent for metallosis (Fig. 3). Aggressive debridement was carried out, acetabular defects were filled with bone graft. Revision incorporated 32mm ceramic head (Biolox-delta), highly cross-linked liner and 52mm trabecular-metal shell (Depuy). Functionally the patient has continued to improve. By 6 months, serum ion concentrations decreased to Co:1.3 and Cr:2.54µg/ L with most recent ion levels lower still (Co:0.66 and Cr:0.42µg/ L). Ceramic head surfaces showed normal wear appearance. The large gray stripe identified on the highly polished dome contained Co and Cr metal-transfer from the CoCr liner (Fig. 2b). Thin gray stripes on equatorial head regions (x4 rougher than dome) represented contamination by Ti, Al and V, typical of adverse impingement against Ti6Al4V neck (Clarke 2013). There was a 100–150um defect on rim of CoCr liner as a result of impingement. Cup out-of-roundness was 476um compared to only 7um for ceramic head, thus cup wear dominated at 25–30mm. 3. volume. This case report was illustrative of the unpredictable and seldom diagnosed risk of habitual cup-to-neck impingement and the risk of relying on pristine simulator studies to predict outcomes in novel THA bearings. For any figures or tables, please contact authors directly (see Info & Metrics tab above).

Aseptic loosening caused by UHMWPE wear debris induced osteolysis is a major cause of revision in total hip arthroplasty (THA). 1. While second generation hard-on-hard bearings, metal-on-metal (MOM) and ceramic-on-ceramic (COC), have been shown clinically to address the wear issues associated with conventional UHMWPE bearings, there remain some concerns over the potential effects of metal ions produced by MOM and the risk of liner fracture in COC. Recently, hybrid ceramic-on-metal (COM) articulation has received a great deal of attention as a promising alternative bearing. Advantages include reduced wear and metal ion release compared with MOM. In addition, it is thought that there may be a reduced tendency for fracture of the ceramic component due to the softer metallic cup. In this study a 5 million cycle wear test was carried out on the Mark II Durham Hip Wear Simulator. A set of six, 38mm diameter HIPed alumina heads and as-cast CoCr alloy cups were tested in bovine serum. Surface topography analysis was carried out at 0, 2, 3 and 5 million cycles. Additionally imaging of the bearing surfaces using ESEM and AFM was undertaken on the final bearing surface. Friction testing, using the Durham Hip Friction Simulator was carried out on one of the joints worn to 5 million cycles and the results were compared with theoretical calculations. Wear of the ceramic heads was virtually undetectable using the conventional gravimetric methods. However, minor surface damage in the form of grain pull out and abrasive scratches was observed in the wear patch when the bearing surfaces were analysed using ESEM and AFM. The grains were not visible in the unworn sections of the head. The average surface roughness remained constant throughout the test. The CoCr cups showed a decrease in roughness between 0 and 2 million cycles, after which it remained relatively constant. This was consistent with the wear results in which a biphasic wear rate was found. The more frequently obtained wear results showed running in wear rate of 1.02±0.078 mm3/million cycles between 0–0.5 million cycles, followed by a steady state wear rate of 0.030±0.011 mm3/million cycles. These results are consistent with those of a recent study undertaken elsewhere. 2. . Friction testing produced a Stribeck curve which was indicative of full fluid film lubrication with a friction factor of 0.027±0.002 for 25% bovine serum (η=0.0014 Pa s-1). Other tests were also carried out using carboxy methyl cellulose fluid as the lubricant to investigate the effect of proteins. This showed that there was a small decrease in friction factor when proteins were absent from the lubricant. It is thought that the difference in friction factors is due to adsorption of the proteins onto the bearing surfaces, when lubricated in bovine serum. This introduces large proteins between the bearing surfaces, which penetrate the lubricant film, causing protein on protein interactions, in addition to the friction caused by shearing of the lubricant film