Abstract. Background. Oxidized zirconium (OxZr) has been introduced as an alternative bearing for femoral components in Total Knee Arthroplasty (TKA). It has a ceramic-like zirconium oxide outer layer with a low coefficient of friction. Early studies have found OxZr TKA to have a low incidence of early failure in young high demand patients. Currently no study has reported on the outcome of these implants beyond ten years. Objectives. The purpose of our study was to present an in-depth 15-year survival analysis of cemented Profix II OxZr TKA. Study Design & Methods. Data was collected prospectively and survival analysis undertaken with multiple strict end points. Complication rates were recorded and patient reported outcomes were measured. Results. 617 Profix II OxZr TKAs were performed over four years. Forty-nine patients underwent reoperation. Aseptic tibial loosening was the most common cause of failure (32.7%) on average occurring 2.8 years post primary procedure. There was one recorded failure due to loosening of the zirconium femoral component. Revision rate at 15-years was 6.38%. Cumulative survivorship was 91.52% with failure considered to be reoperation for any reason. WOMAC score improved in 86% of patients by year 1. The average score improved by 21.2 points and met the standard for minimum clinically important difference. Conclusions. This study presents the first 15-year survival analysis of cemented Profix II OxZr TKA. Our data supports current literature on the long-term survivorship of oxidised zirconium total knee replacements

Introduction: Long term performance of total knee replacements is governed by wear of ultra-high molecular weight polyethylene (UHMWPE) which leads to aseptic loosening of the implant. Little has been done to reduce wear due to the femoral component properties in knee joint replacement. Scratching of the femoral component has been identified in retrieved knee replacements. Using a material that has a higher scratch resistance than current metals may reduce the rate of UHMWPE wear in knee replacements. In this study we investigated the effects of using an oxidized Zirconium femoral component has on wear in knee replacements. Methods: Total knee replacements made of CoCr and oxidised zirconium were tested in a four station, six degrees of motion knee simulator for 4 million cycles. The surface roughness values (Ra, Rz and Sm) for the metal counterfaces was measured through the test. In addition gravimetric wear of the UHMWPE inserts was recorded. Scanning electron microscopy of the two counterface surfaces was performed to provide information on possible mechanisms involved in the wear process. Results: The starting surface roughness for both CoCr and oxidised zirconium were similar (Ra=0.03m). Oxidised zirconium was significantly more scratch resistant than CoCr; Ra (mean average roughness) of 0.7m compared to 0.43m (p< < 0.01) at end of test, with similar differences in the other surface roughness parameters. This was accompanied by a 4 fold reduction in wear of UHMWPE 49.60mg to 12.48mg (p=0.02). SEM analysis of the surfaces of the metals revealed large deep scratches of the CoCr implants which were aligned in the A-P sliding direction. Barium sulphate particles were seen embedded in the surface of the femoral component. Voids were seen in the surface of the cobalt chrome and particles of silicate polishing powder were seen in these voids. There was also evidence of scratches originating at these voids. By contrast oxidised zirconium, showed small amounts of superficial scratching with an intact surface and no evidence of third body particles. Summary and conclusions: Oxidised zirconium leads to a reduction in wear of UHMWPE due to its increased resistance to third body wear. It has the potential to increase the longevity of total knee replacements by reducing wear of UHMWPE. Additionally, polishing powder used in the manufacture of cobalt chrome femoral components of knee joint replacements is a potential source of third body particles

Introduction. Wear-related osteolysis continues to be a concern in the long-term outcome and survivorship of total hip arthroplasty (THA) and there continues to be an emphasis on bearing materials that exhibit improved wear profiles. Oxidized zirconium metal (Oxinium®, Smith & Nephew) was developed to reduce the amount of polyethylene wear as compared to cobalt chromium femoral heads, without the risk of brittle fracture seen with older generation ceramics. There are a limited number of retrieval studies evaluating the performance of Oxinium in THA. The aims of this study were 1) to visually assess damage on the surface of a large number of retrieved Oxinium femoral heads, 2) to measure surface roughness of scratches on the surfaces of Oxinium femoral heads, and 3) to use scanning electron microscopy (SEM) to assess the integrity of the oxidized zirconium surface in damaged areas. BIOLOX delta (CeramTec), a ceramic alternative to Oxinium, was included in this study for comparison. Methods. From 2006 to 2013, 59 retrieved Oxinium femoral heads in THAs were collected after an average time to revision surgery of 1.64 years. The mean patient age was 61.9 years, with 32 males and 27 females. Reasons for revision surgery were recurrent dislocation (24), femoral component loosening or subsidence (13), infection (9), acetabular loosening (4), periprosthethic fracture (4), acetabular malposition (2), heterotopic ossification (2), and 1 case of leg length discrepancy. The diameters of the femoral heads were 28 mm (9), 32 mm (22), 36mm (26) and 40mm (2). Three observers visually graded surface damage on all femoral heads according to the following criteria: 1) no scratches, 2) minimal damage with one to two scratches, 3) significant damage with multiple scratches. We measured the surface roughness of retrieved Oxinium and BIOLOX delta femoral heads with an interferomic profiler, and SEM to evaluate the extent of surface effacement. Results. Oxinium femoral heads explanted for recurrent dislocation showed substantially more severe damage as compared to heads retrieved during revision surgery for other reasons (p<0.001). Eighteen of 24 heads explanted for recurrent dislocation (75%) showed gross visual evidence of substantial surface damage (grade 3), compared to only 5 of the 35 explants for non-dislocation causes (Figure 1). The surface roughness of damaged Oxinium femoral heads was significantly higher (28.6× more rough) than undamaged Oxnium and 17.7× more rough than damaged Biolox delta heads (p<0.001; Figure 2). High magnification imaging showed severe damage and effacement of the oxidized zirconium layer, exposing the metal alloy underneath (Figure 3). This was confirmed by Energy Dispersive Xray Analysis (EDXA). Discussion. This study represents the first large-scale retrieval analysis of oxidized zirconium femoral heads in THA. The results show that high impact between an acetabular shell and an Oxinium femoral head during dislocation increases the surface roughness and causes substantial effacement to the oxidized zirconium layer compared with matched modern ceramic bearings. The surface damage seen to these femoral heads is of clinical concern because it has the potential to increase the wear of polyethylene liners in THA

Zirconium total knee replacements theoretically have a low incidence of failure as they are low friction, hard wearing and hypo allergenic; we present the five year survival data. Data was collected prospectively from 212 patients who underwent Profix zirconium total knee replacements with an all-polyethylene tibial component. Revision surgery or a Knee Society Roentgenographic Evaluation System (KSRES) score of 10 or more was considered failure. SF 12 and WOMAC scores were recorded preoperatively, at three months, at one year, at three years and at five years. KSRES scores were recorded at all postoperative intervals. There were 92 male and 120 female patients with a median age of 63 years, range 25 to 87. 188 implants were for osteoarthritis and 24 were for rheumatoid arthritis. Eight patients died and six were lost to follow up, the remaining 198 patients reached a minimum of five year follow-up. At five years, the mean WOMAC score improved from 56 to 35 and the mean SF12 physical component score improved from 28 to 34. The mean SF12 mental component score remained unchanged at 51. The five year survival with failure due to implant related reasons was 99.5% (95% CI 97.3 - 100). This was due to one tibial component becoming aseptically loose in the first year. Reoperations excluded from this analysis were downsizing of the tibial component for stiffness and patella resurfacing. When these were included the five year survival was 98.1% (95% CI 95.1 - 99.3). Our results demonstrate that the Profix zirconium total knee replacement has a low medium term failure rate comparable to the best implants. Further research is needed to establish if the beneficial properties of zirconium improve long term implant survival

Introduction. Detailed analysis of retrieved total hip replacements (THRs) is valuable for assessing implant and material successes and failures. Reduction of bearing wear and corrosion and fretting of the head-neck trunnion is essential to implant durability and patient health. This research quantifies and characterizes taper and bearing surface damage on retrieved oxidized zirconium THRs. Methods. Initially, 11 retrieved oxidized zirconium femoral heads were examined along with their associated femoral stems. Relevant patient and retrieval data was collected from clinical charts and radiographs. Taper corrosion (Figure 1) and fretting damage (Figure 2) scoring was performed following the Dyrkacz [1] method. A coordinate measuring machine was used to obtain a detailed surface map of the male and female taper surfaces. Taper surface maps were best-fit with an idealized cone followed by volume subtraction to quantify the amount of material removed as a result of fretting and corrosion processes. Scanning electron microscopy was performed on select samples to identify specific damage modes. Unique surface bumps were noted on the articular surface of select femoral heads (Figure 3). Seventeen femoral heads were added to the analysis specifically for identification of these bumps. Articular surfaces were searched under SEM magnification and bumps were identified and counted. Parametric statistical correlations were performed with SAS v9.3. Results. Mean patient age was 61 years (Range: 35–95) with mean implantation period being 2.0 years (Range: 0.1–11.4) and mean body mass index of 29 kg/m. 2. (Range: 22–46). Revision for infection (n=11), peri-prosthetic fracture (n=5) and dislocation (n=5) were the main reasons for revision. Mean corrosion damage scores were 2.0 and 3.6 (head, neck) while mean fretting damage scores were 8.5 and 5.8 (head, neck). Fretting damage score was weakly correlated with implantation period (p=0.07) while corrosion damage score was not. Mean corrosion and fretting volume measured 0.40 mm. 3. and 0.87 mm. 3. (head, neck). Volume of corrosion and fretting damage did not correlate with implantation period; however neck volume correlated with inclination angle of the acetabular cup (p<0.01). Bearing diameter was not found to correlate with corrosion and fretting damage score or volume. The unique surface bumps were identified in 12 of 28 samples, with 3 samples having <10 bumps. Presence of these bumps did not appear to be related to bearing diameter, implantation period, or any damage metrics. Conclusion. Fretting damage was found to correlate with implantation period, suggesting that is a continuous in vivo process; however, this was not found for corrosion damage. Fretting damage volume correlated with acetabular cup angle; however, this may be coincidence as only 8 samples were included in the analysis. Overall, our corrosion damage scores (2.0–3.6) were lower than previously published values for 28mm & 36mm cobalt-chrome heads (4.5–13.1) [1]. However, our fretting damage scores (5.8–8.5) were higher than previously published (2.8–4.4) [1]. Greater fretting damage on the oxidized zirconium heads may be explained by the softer zirconium alloy compared to that of cobalt-chromium. Further subsurface investigation of the surface bumps is underway using a focused ion beam mill

Oxidized zirconium (Oxinium) and highly cross-linked polyethylene (HXLPE) were developed with the purpose of minimizing wear, and subsequent osteolysis, in Total Hip Arthroplasty (THA). However, few articles have been published on long-term results of Oxinium on highly cross-linked polyethylene. The purpose of this investigation is to report minimum 10-year HXLPE wear rates and the clinical outcome of patients in this group and compare this population to a control group of cobalt chrome and ceramic. One hundred forty THAs were performed for 123 patients using an Oxinium head with an HXLPE liner. Ninety-seven had 10 years of clinical follow-up (avg. 14.5). Harris Hip Scores (HHS) were collected preoperatively and at the most recent follow-up. Radiographs of 85 hips were available for a minimum 10-year follow-up (avg. 14.5) and used to calculate wear using PolyWare software. Control groups of cobalt chrome and ceramic articulation on HXLPE with a minimum 10-year follow-up were studied. Clinical follow-up of the Oxinium group showed a statistical improvement compared to preoperative and was similar to the control group of patients. Radiographic evaluation found the linear and volumetric wear rates for the Oxinium group of 0.03 mm/year (range 0.00–0.08) and 3.46 mm. 3. /year (range 1.0 to 15.0) respectively. There was no statistically significant difference in linear or volumetric wear rate between the groups (P-value 0.92 and 0.55 respectively). None of these patients underwent revision of their hip for any reason. Oxinium on highly cross-linked polyethylene has performed exceptionally with wear rates comparable to those of cobalt chrome or ceramic on HXLPE

Background And Aims: Total knee replacements provide a cost effective treatment for painful joint conditions such as osteoarthritis. Their long term performance is governed by ultra-high molecular weight polyethylene (UHMWPE) wear which produces wear debris and leads to osteolysis and aseptic loosening of the implant. Using a new material which is more scratch resistant than cobalt chrome it is hoped to reduce wear of UHMWPE and its subsequent complications. Methods: Two total knee replacements made from cobalt chrome and two of oxidised zirconium were wear tested in a knee simulator. Surface roughness data from the femoral components was collected. Gravimetric and volumetric wear of the polyethylene inserts was measured. SEM analysis of the surfaces was also performed. Results: Oxidised zirconium is significantly more scratch resistant than CoCr; Ra (mean average roughness) of 0.7μm compared to 0.43μm (p< < 0.01) at end of test, and confirmed by SEM analysis. This was accompanied by a 4 fold reduction in wear of UHMWPE 49.60mg to 12.48mg (p=0.02). Barium sulphate particles were found to be embedded in the surface of the CoCr implants. Summary And Conclusions: Oxidised zirconium leads to a reduction in wear of UHMWPE due to its increased resistance to third body wear. It has the potential to increase the longevity of total knee replacements by reducing UHMWPE related complications

Introduction. The development of new bearing surfaces for total joint replacement is constantly evolving. Oxidized zirconium (Oxinium) has been introduced for use in total hip arthroplasty (THA) and total knee arthroplasty (TKA). One of the most common causes of failure of THA is aseptic loosening secondary to polyethylene wear debris. The aetiology of wear is multifactorial and includes adhesive, abrasive, third-body and fatigue wear mechanisms. Oxidized zirconium is a relatively new material that features an oxidized ceramic surface chemically bonded to a hard metallic substrate. This material possesses the reduced polyethylene wear characteristics of a ceramic, without the increased risk of implant fracture While short-term results of oxidized zirconium in THA have been reported, there have been no reports on retrieved highly cross linked PE articulating with Oxinium headsObjectives:. Objectives. The purpose of this study was to compare matched pairs of retrieved highly cross-linked polyethylene (XLPE) acetabular liners with OxZr and CoCr articulation. The liners were examined for evidence of wear damage, including articular surface damage, impingement, screw-hole creep, and rim cracks. Materials and Methods. Four retrieved highly cross-linked polyethylene (XLPE) acetabular liners with 32mm OxZr femoral heads were identified and matched to four retrieved highly cross-linked polyethylene (XLPE) acetabular liners with 32mm CoCr femoral heads by duration of implantation, patient age, and body mass index. Visual damage grading of the articular surface was performed by two independent graders by direct visualization and by light stereomicroscopy. The articular surfaces were subjectively graded for abrasion, burnishing, cracking, delamination, pitting, plastic deformation, third body debris, and scratching using a 0 to 3 scale as described by Hood et al. Liners were divided into quadrants with the elevated rim, when present, to the left and the quadrants labeled in a clockwise fashion beginning in the upper left hand corner. When an elevated rim was not present, liners were divided into quadrants based on the ocation of the etchings. Each quadrant was scored separately. Results. The retrieved components showed predominantly abrasion and burnishing primarily in zones 1 and 2 representing the supero-anterior and supero- posterior regions in the liner. The mean damage score for the Oxinium group was 17.3 vs 23.3 in the CoCr group. The mean time in vivo for the oxinium group was 7.1 yrs vs 4.5 yrs for the CoCr group. Interestingly, the damage scores in zones 3 and 4 were very similar in both groups representing the infero post and anterior portions on the liner. Conclusion. The development of new bearing surfaces for total joint replacement is constantly evolving and will continue to do so as polyethylene wear and osteolysis continue to be a major problem in the long-term survival of total hip arthoplasties. CoCr roughens significantly more in situ compared with OxZr components. Despite the small number of retrieved implants in our study, OxZr demonstrated lower damage on XLPE liners when compared to the CoCr group. Longer-term studies will be necessary to establish the overall clinical fatigue performance of highly crosslinked liners with newer bearing surfaces such as OxZr

While Oxidized Zirconium (OxZr) femoral heads matched with highly cross-linked polyethylene (XLPE) have demonstrated the lowest rate of revision compared to other bearing couples in the Australian National Joint Registry, it has been postulated that these results may, in part, be due to the fact that a single company offers this bearing option with a limited combination of femoral and acetabular prostheses. The purpose of this study was to assess clinical and radiographic outcomes in a matched cohort of total hip replacements (THR) utilizing an identical cementless femoral stem and acetabular component with either an Oxidized Zirconium (OxZr) or Cobalt-Chrome (CoCr) femoral heads at a minimum of 10 years follow-up. We reviewed our institutional database to identify all patients whom underwent a THR with a single cementless femoral stem, acetabular component, XLPE liner and OxZr femoral head with a minimum of 10 years of follow-up. These were then matched to patients who underwent a THR with identical prosthesis combinations with CoCr femoral head by gender, age and BMI. All patients were prospectively evaluated with WOMAC, SF-12 and Harris Hip Score (HHS) preoperatively and postoperatively at 6 weeks, 3 months, 1 and 2 years and every 2 years thereafter. Charts and radiographs were reviewed to determine the revision rates and survivorship (both all cause and aseptic) at 10 years for both cohorts. Paired analysis was performed to determine if differences exist in patient reported outcomes. There were 208 OxZr THRs identified which were matched with 208 CoCr THRs. There was no difference in average age (OxZr, 54.58 years, CoCr, 54.75 years), gender (OxZr 47.6% female, CoCr 47.6% female), and average body max index (OxZr, 31.36 kg/m2, CoCr, 31.12 kg/m2) between the two cohorts. There were no significant differences preoperatively in any of the outcome scores between the two groups (WOMAC (p=0.449), SF-12 (p=0.379), HHS(p=0.3718)). Both the SF12 (p=0.446) and the WOMAC (p=0.278) were similar between the two groups, however the OxZr THR cohort had slightly better HHS compared to the CoCr THR cohort (92.6 vs. 89.7, p=0.039). With revision for any reason as the end point, there was no significant difference in 10 years survivorship between groups (OxZr 98.5%, CoCr 96.6%, p=0.08). Similarly, aseptic revisions demonstrated comparable survivorship rates at 10 year between the OxZr (99.5%) and CoCr groups (97.6%)(p=0.15). Both THR cohorts demonstrated outstanding survivorship and improvement in patient reported outcomes. The only difference was a slightly better HHS score for the OxZr cohort which may represent selection bias, where OxZr implants were perhaps implanted in more active patients. Implant survivorship was excellent and not dissimilar for both the OxZr and CoCr groups at 10 years. Therefore, with respect to implant longevity at the end of the first decade, there appears to be no clear advantage of OxZr heads compared to CoCr heads when paired with XLPE for patients with similar demographics. Further follow-up into the second and third decade may be required to demonstrate if a difference does exist

The purpose of this study was to precisely measure the 10-year polyethylene wear rate of primary total hips using Radiostereometric analysis (RSA) comparing Oxidized Zirconium (OxZi) to cobalt chrome (CoCr) femoral heads articulating with highly cross-linked polyethylene (XLPE). RSA was performed on 46 patients who underwent total hip arthroplasty − 23 who received OxZi femoral heads and 23 who received CoCr heads in combination with XLPE at a minimum of 10 years follow-up. All patients had identical THR systems implanted except for the femoral head utilized. The Centre Index method was utilised to assess total wear rates (from index surgery until final evaluation) using a dedicated RSA Software program (UmRSA Digital Measure v.2.2.1). In addition, the Martell technique was used to subtract head penetration occurring in the first 1–2 years (i.e. bedding-in phase) to allow calculation of the ‘steady state’ wear rates. There were no significant differences in demographics (i.e age, BMI, gender) between the groups. The average time from surgery of the RSA examinations was 11.7 and 12.6 years for the CoCr and OxZi groups respectively. Using the Centre Index Method to calculate total head penetration, wear rates were slightly higher in the OxZi group (0.048 +/− 0.021mm/year) compared to the CoCr group (0.035 +/− 0.017mm/year) with no statistical difference between the groups (p= 0.02). After correction for the bedding-in period, there was no statistically significant difference in mean ‘steady-state’ wear rate between OxZi (0.031 +/− 0.021mm/year) and CoCr (0.024 +/− 0.019mm/year) at 10 year follow up (p= 0.24). A comparison of preoperative and postoperative SF12, HHS, and WOMAC scores showed no statistical difference between the groups. RSA demonstrated the 10 year in-vivo wear rates of both bearing combinations to be well below the threshold for osteolysis. There was no significant difference between either the total or ‘steady-state’ wear rates of the OxZi and CoCr groups at 10 years

Total knee arthroplasty is a well-established treatment for degenerative joint disease, on the other hand metal ion release of cobalt or chromium and particle formation can trigger intolerance reactions. Biotribological examinations can help to assess the metal ion release in different settings. The purpose of this study was the evaluation of inter-laboratory differences in the metal ion concentration analysis. Samples were generated in a 3+1 station knee wear simulator (EndoLab GmbH, Thansau, Germany) with a medium size Columbus Knee System with or without AS multilayer coating. The wear simulation was performed under highly demanding activity (HDA) profile and samples were taken after 0.5, 5.0, 5.5. and 8.0 million cycles. The samples were blinded and sent to three different laboratories and the content of chromium, cobalt, molybdenum, nickel, and zirconium was assessed by inductively coupled plasma mass spectrometry (ICP-MS). The AS multilayer coating clearly reduced the release of chromium, cobalt and molybdenum. Mean levels were: Chromium 9329.78µg/l ± 985.44 vs 503.75µg/l ± 54.19, cobalt 10419.00µg/l ± 15.517.53 vs 2.60µg/l ± 1.35, molybdenum 2496.33µg/l ± 102.62 vs 2.46µg/l ± 2.31. Interestingly we found especially for nickel and zirconium big inter-laboratory differences in the metal assessment. There were up to 10-fold higher values in comparison of one laboratory to another. The data demonstrate that results of metal ion assessment should be evaluated by interlaboratory comparison and should be critically interpreted

This study reports the ten-year polyethylene liner wear rates, incidence of osteolysis, clinical outcomes and complications of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. Blinded observers recorded predefined outcomes in 262 study patients at regular intervals for ten years following THA. At ten years follow-up, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C were associated with increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non-significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up when measuring normalised Western Ontario and McMaster Universities Osteoarthritis Index(p=0.410), short-form-36 (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p=0.451). The use of UHMWPE was associated with progressively increased annual liner wear rates after THA. At ten years follow-up, this translated to UHMWPE leading to an increased incidence of osteolysis and aseptic loosening requiring revision THA, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups

This study reports the ten-year outcomes of a three-arm, multicentre randomised controlled trial comparing Cobalt-Chrome (CoCr) and Oxidised Zirconium (OxZr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and XLPE liner; Group B received an OxZr femoral head and XLPE liner; and Group C received an OxZr femoral head and UHMWPE liner. The outcomes of 262 study patients were analysed at ten years follow-up. At ten years, increased linear wear rates were recorded in group C compared to group A (0.133 ± 0.21 mm/yr vs 0.031 ± 0.07 mm/yr respectively, p<0.001) and group B (0.133 ± 0.21 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p<0.001). Patients in group C had increased risk of osteolysis and aseptic loosening requiring revision surgery compared with group A (7/133 vs 0/133 respectively, p=0.007) and group B (7/133 vs 0/135 respectively, p=0.007). There was a non- significant trend towards increased liner wear rates in group A compared to group B (0.031 ± 0.07 mm/yr vs 0.022 ± 0.05 mm/yr respectively, p=0.128). All three groups were statistically comparable preoperatively and at ten years follow-up from a clinical score perspective. The use of UHMWPE was associated with progressively increased annual liner wear rates. At ten years follow-up, this translated to an increased incidence of osteolysis and aseptic loosening requiring revision, compared with XLPE. Femoral heads composed of OxZr were associated with a non-significant trend towards reduced wear rates compared to CoCr, but this did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two treatments groups

Introduction. Metal ion and particle release, particularly cobalt, has become an important subject in total hip arthroplasty, as it has shown to induce metal hypersensitivity, adverse local tissue reactions and systemic ion related diseases. The purpose of the following study was compare the ion release barrier function of a zirconium nitride (ZrN) multilayer coated hip stem for cemented use, designed for patients with metal ion hypersensitivity, against its uncoated version in a test configuration simulating the worst case scenario of a severely debonded hip stem. The ZrN multilayer coating is applied on a CoCrMo hip stem and consists of a thin adhesive chromium layer, five alternating intermediate layers out of chromium nitride (CrN) and chromium carbonitride (CrCN) and a final zirconium nitride (ZrN) shielding layer [1]. Methods. Hip stems with a ZrN multilayer coating (CoreHip AS, Aesculap AG, Germany) were tested in comparison with a cobalt-chrome uncoated version (CoreHip, Aesculap AG, Germany). In order to create a worst case scenario, the smallest stem size with the biggest offset in combination with an XL ceramic head (offset +7 mm) was used. The stems were embedded according to the ISO 7206-6 test in a bone cement sheet. Once the bone cement was bonded, the stem was pulled out and a PMMA grain was placed inside the femoral cavity in order to uprise the hip stem above its embedding line and simulate a debonded cemented hip stem with a severe toggling condition. The dynamic test was performed under bovine serum environment with an axial force of 3.875 kN [2] at 11.6 Hz for 15 million cycles. The test was interrupted after 1, 3, 5, 10 and 15 million cycles and the surfaces of the stems were analyzed through scanning electron microscopy (SEM) with energy dispersive X-Ray (EDX). Moreover, the test medium was analyzed for metal ion concentration (cobalt, chromium and molybdenum) using ICP-MS. Results. The SEM/EDX analysis demonstrated that the ZrN multilayer coating kept its integrity, as no trace of the substrate material (CoCrMo) could be detected. Furthermore, the taper of the ZrN group showed less fretting and corrosion than the taper of the CoCrMo stem (Fig.1). Moreover, the ion concentration analysis showed a reduction of up to two orders of magnitude in the release of cobalt, chromium and molybdenum in the ZrN coated stems in comparison with the uncoated version. Discussion. The results showed that, even in a worst case scenario of high micro-motion due to a severe stem debonding within the cement mantle, the hip stems with a ZrN multilayer coating substantially reduce the release of ions from the substrate material. For any figures or tables, please contact the authors directly

Oxidized Zirconium (OxZr), metallic zirconium alloy oxidized to form a ceramic surface, was developed as an alternative bearing material to cobalt-chrome (CoCr) alloy for improvements in roughening resistance, frictional behavior, and biocompatibility without a risk of brittle fracture. Knee simulator testing without intentional addition of abrasives demonstrated that the ultra-high molecular weight polyethylene (UHMWPE) wear rate was 85% less with OxZr than with CoCr femorals. The relative performance of articulating materials can change when tested under abrasive conditions, so test protocols were investigated with abrasives added directly to the simulator test lubricant. Testing was conducted on a six-station, four-axis, physiological knee simulator. OxZr and CoCr medium-sized, cruciate-retaining, femoral components were tested against UHMWPE tibial inserts sterilized by ethylene oxide. Alumina powder was mixed into 50% bovine serum lubricant at a concentration of 0.2 mg/cm3. Tests were conducted with different powder sizes in the range of 0.3 to 150 μm. Measurements included tibial insert weight and femoral surface roughness. The lubricant in CoCr tests became opaque with gray debris while the femoral condyles became scratched. In contrast, the lubricant in OxZr tests remained normal (as in tests without abrasives), and femoral condyle scratching was much less severe. Despite these obvious effects, the UHMWPE wear produced by each material did not increase appreciably over that of tests without abrasives, with OxZr maintaining a wear rate about 85% less than for CoCr. It was noted that the scratches were aligned, or became realigned, with the translation motion and had little evidence of the swirls or cross-hatching often observed on retrieved components. Previous testing indicates that UHMWPE wear increases significantly only if scratches are oblique to the sliding direction. Thus, a test technique that produces scratches with more clinically relevant orientations is needed for a performance comparison between femoral materials under abrasive conditions

INTRODUCTION. The development of new bearing surfaces for total joint replacement is constantly evolving. Oxidized zirconium (Oxinium) has been introduced for use in both total hip arthroplasty (THA) and total knee arthroplasty (TKA). The aetiology of wear is multifactorial and includes adhesive, abrasive, third-body and fatigue wear mechanisms. Oxinium femoral components have demonstrated clear improvements in wear characteristics in-vitro. The purpose of this prospective study was to evaluate the mid-term (minimum 5 year) clinical and radiographic results and survivorship of the Genesis II™ knee implant system using an Oxinium femoral component. METHODS. Between January 2001 and December 2008, 382 Genesis II Oxinium (Smith & Nephew) primary total knee arthroplasties (TKA) (313 patients) were implanted at our institution. A comparison with a cohort of 317 patients (382 knees) who received a Genesis II knee implant using a ‘conventional’ cobalt-chrome (Co-Cr) femoral component was performed during the same time period. Prospective data was collected on all patients including demographics (age, BMI, diagnosis) as well as pre and postoperative clinical outcome scores (SF-12, WOMAC, and knee society clinical rating scores (KSCRS). Radiological analysis for evidence of osteolysis and loosening was performed in all patients. Comparisons were performed to determine differences between the Oxinium and Cobalt Chrome cohorts. Kaplan-Meier survival analysis was performed to show cumulative survival over time. Failure was defined as femoral component revision due to any cause. RESULTS. The mean age at time of surgery was 54.0 and 60.6 years respectively for the Oxinium and Co-Cr groups. The mean time from surgery was 8.13 +/− 2.03 years and 8.59 +/− 2.01 years for the Oxinium and Co-Cr groups respectively. Both groups demonstrated a statistically significant improvement in clinical outcome measures between pre, and post operative SF-12, WOMAC, and KSCRS scoring systems with no difference between two groups. There were a total of 15 revisions (infection: 8, stiffness: 2, aseptic loosening of patella component: 2, Aseptic loosening of the tibial component: 1, instability: 1, and one malaligned Femoral Component) in the Oxinium group. In the CoCr group there were a total of 9 revisions (Infection:5, aseptic loosening:1, instability: 1, stiffness: 1 and one patient revised for unexplained pain). Radiographically, no loosening was noted in the Oxinium group and all implants appeared well fixed. There was one case of loosening seen in the cobalt chrome group. The overall survival was 99.7 for both Oxinium and CoCr femoral components. Our study demonstrated no significant differences in validated clinical outcome scores and radiographic outcomes when comparing the Oxinium and Co-Cr femoral components. CONCLUSION. Despite the large numbers in our study, there were no statistically significant differences between Oxinium and CoCr femoral components at a minimum of five years follow up. While no clear benefits have been demonstrated, the use of an Oxinium femoral component demonstrated no adverse events at mid-term follow-up. Conventional Co-Cr femoral components remain the gold standard while long-term follow-up data is required to demonstrate the potential benefits of Oxinium

The aim of this study is to compare the release of titanium (Ti) and zirconium (Zr) into the tissue surrounding Ti- and ZrO. 2. -implants. Methyl methacrylate embedded mini pig maxillae with 6 Ti-implants and 4 ZrO2-implants were analysed after 12-weeks of implantation. The spatial distribution of elemental Ti and Zr in maxillae near implants was assessed with laser ablation (LA)-inductively coupled plasma (ICP)-mass spectrometry (MS). From each maxilla two bone slices adjacent to the implants were measured. The contents of Ti and Zr in these bone slices were determined by ICP-MS and ICP-optical emission spectrometry. Increased intensity of Ti and Zr could be detected in bone tissues at a distance of 891±398 µm (mean ± SD) from Ti-implants and 927±404 µm from ZrO2-implants. The increased intensity was mainly detected near implant screw threads. The average Ti content detected in 11 bone slices from samples with Ti-implants was 1.67 mg/kg, which is significantly higher than the Ti content detected in 8 slices from samples with ZrO. 2. -implants. The highest Ti content detected was 2.17 mg/kg. The average Zr content in 4 bone slices from samples with ZrO. 2. -implants is 0.59 mg/Kg, the other 4 bone slices showed Zr contents below the detection limit (. After 12-weeks of implantation, increased intensity of Ti and Zr can be detected in bone tissues near Ti- and ZrO. 2. -implants. The results show that Ti content released from Ti-implants is higher than the Zr content released from ZrO. 2. -implants

Purpose. The success of total knee replacement (TKR) surgery can be attributed to improvements in TKR design, instrumentation, and surgical technique. Over a decade ago oxidized zirconium (OxZr) femoral components were introduced as an alternative bearing surface to cobalt-chromium (CoCr), based on strong in-vitro evidence, to improve the longevity of TKR implants. Early reports have demonstrated the clinical success of this material however no long-term comparative studies have demonstrated the superiority of OxZr implants compared to a more traditional CoCr implant. This study aims to compare long-term survivorship and outcomes in OxZr and CoCr femoral components in a single total knee design. Methods. We reviewed our institutional database to identify all patients whom underwent a TKA with a posterior stabilized OxZr femoral component with a minimum of 10 years of follow-up. These were then matched to patients whom underwent a TKA with the identical design posterior stabilized CoCr femoral component during the same time period by gender, age and BMI. All patients had their patella resurfaced. All patients were prospectively evaluated preoperatively and postoperatively at 6 weeks, 3 months, 12 months, 2 years and every 1 to 2 years thereafter. Prospectively collected clinical outcome measures included, Western Ontario and McMaster Universities osteoarthritis index (WOMAC), Short-Form 12 (SF-12) and Knee Society clinical rating scores (KSCRS). Charts and radiographs were reviewed to determine the revision rates and survivorship (both all cause and aseptic) at 10 years allowing comparison between the two cohorts. Paired analysis was performed to determine if differences existed in patient reported outcomes. Results. There were 194 OxZr TKAs identified and matched to 194 CoCr TKAs. There was no difference in average age (OxZr, 54.2 years; CoCr, 54.4 years), Gender (OxZr, 61.9% female; CoCr, 61.9% female) and average body mass index (OxZr, 35.9 kg/m2; CoCr, 36.4 kg/m2) between the two cohorts. There were no significant differences preoperatively in any of the outcome scores between the two groups (WOMAC (p=0.361), SF-12 (p=0.771) and KSCRS (p=0.161)). Both the SF12 (p=0.787) and WOMAC (p=0.454) were similar between the two groups, however the OxZr TKA cohort had superior KSCRS compared to the CoCr TKA cohort at a minimum of 10 years (173.5 vs. 159.1, p=0.002). With revision for any reason as the end point, there was no significant difference in 10-year survivorship between the two groups (OxZr and CoCr, 96.4%, p=0.898). Similarly, aseptic revisions demonstrated comparable survivorship rates at 10-year between the OxZr (98.9%) and CoCr groups (97.9%) (p=0.404). Conclusion. In this matched cohort study, both groups demonstrated similar improvements in patient reported outcomes, although the OxZr cohort had greater KSCRS scores compared to the CoCr cohort. The reason for this difference is not clear but may represent selection bias, where OxZr implants were perhaps used in more active patients. Implant survivorship, based on revision rates for all causes and/or aseptic reasons, was excellent and similar for both the OxZr and CoCr femoral components at 10 years. Therefore, with respect to implant longevity at the end of the first decade, there appears to be no clear advantage of OxZr compared to CoCr for patients with similar demographics with this specific posterior stabilized TKA design. Further follow-up into the second and third decade may be required to demonstrate if a difference does exist

Introduction. Oxidized zirconium (OxZr) is used as a ceramic surface for femoral components in total knee arthroplasty (TKA). The aim of this study was to investigate its performance by examining retrieved femoral components and their corresponding PE inserts in matched comparison with conventional chrome/cobalt/molybdenum alloy (CrCoMo). Methods. 11 retrieved posterior stabilized (PS) TKA with an OxZr femoral component were included. From a cohort of 56 retrieved TKA with CrCoMo femoral components, pairs were matched according to duration of implantation, patient age, reason for revision, and BMI. The retrieved tibial polyethylene (PE) inserts were analyzed for wear using the Hood classification. Femoral components were optically viewed at 8–32x magnification and screened for scratching, pitting, delamination, and striation. Profilometry was performed to measure surface roughness of the OxZr components using a non-contact white light profiler. Results. The prostheses were in situ for a mean of 18.5±10.6 (OxZr) and 19.5±14.3 (CrCoMo) months (p=0.41). None of these cases were revised for problems directly related to the use of OxZr. There was one reaction to the implant in the CrCoMo group. The average wear of the tibial PE inserts was significantly lower with OxZr components (41.5±16.8 vs. 60.1±22.0, p=0.01). The average wear score in the visual analysis of the femoral components was significantly lower for the OxZr (1.6±1.3 vs. 9.5±0.6, p=0.005). Discussion and Conclusion. Femoral components made of OxZr are less sensitive to in vivo wear damage than those of CrCoMo. PE inlays show significantly less in vivo wear damage in combination with an OxZr femoral component

INTRODUCTION. One of the recent advances in the hard-on-hard hip arthroplasty is the development of a new material of diffusion hardened oxidised zirconium (DHOxZr). The DHOxZr material consists of a ceramic layer on the top surface which is supported by a thick oxygen diffusion hardened (DH) zone underneath. With the desired properties of metal substrate, ceramic surface and a gradient structure of the oxygen diffusion zone, the DHOxZr-on-DHOxZr bearing combination is expected to produce low wear and minimal metal ions. This can possibly address the concerns associated with metal hypersensitivity associated with metal on metal bearings and fracture risk associated with ceramics. The aim of this study was to evaluate the wear of DHOxZr-on-DHOxZr as a possible hard on hard bearing combination in hips. METHODS. Three pairs of 50 mm DHOxZr prototype hip joint devices, each consisting of a DHOxZr modular head and a DHOxZr liner were wear tested in a ProSim hip joint simulator under standard testing conditions used by the Implant Development Centre (IDC), Smith & Nephew, Leamington Spa for 5 million cycles (Mc). The flexion/extension was 30° and 15°. The internal/external rotation was ± 10°. The force was Paul-type stance phase loading, with a maximum load of 3 kN and a standard ISO swing phase load of 0.3 kN. The test frequency was 1 Hz. Gravimetric analysis was carried out at 0, 0.5, 1, 2, 3, 4 & 5 million cycles. The lubricant was new born calf serum with 2 g/l sodium azide concentration diluted with de-ionised water to achieve average protein concentration of 20 g/l. Lubricant was changed every 0.25Mc during the first million cycles of the test and at every 0.33 Mc from 1 to 5Mc. RESULTS. A biphasic wear pattern was observed for the DHOxZr on DHOxZr devices during the test, with a running in phase from 0–1 Mc and a steady state phase from 1–5 Mc. At a confidence level of 95%, the mean wear rate was 0.21 ±0.06 mm3/Mc during the running-in stage, and the wear rate was reduced to 0.01 ±0.03 mm3/Mc during the steady state for the device tested. The wear volume loss of the DHOxZr on DHOxZr devices was significantly lower than that generated by CoCrMo metal on metal (MoM) devices (p < 0.05) under identical simulator test conditions