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Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_1 | Pages 3 - 3
1 Feb 2015
Haddad F
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A multitude of different bearing combinations exist to recreate the artificial hip joint. To date, there is no particular ‘gold-standard’ total hip arthroplasty (THA) couple since none is faultless. Strategies to improve performance are aimed either at modifying the shape and design of components or their material properties. Wear particle generation is now well recognised as a cause of aseptic loosening which consistently features amongst the most common indication for revision THA and thus minimising wear lies at the cornerstone of developing bearing couples. However, history has shown the use of supposed newer and improved materials have not been without occasional catastrophic failure. Hard-on-hard bearings are theoretically more resistant to wear but component fracture and squeaking has been witnessed with ceramic-on-ceramic articulations whilst metal-on-metal articulations have been plagued by reports of pseudotumor and ALVAL formation. This has all led to resurgence in the hard-on-soft couple. More recently, corrosion at taper junctions has been identified as a significant factor in hip arthroplasty failure. Femoral head materials, surface changes or coatings may therefore have an increasing role to play. In 2005, a multi-center, prospective, assessor and patient-blinded, randomised control trial was initiated. This was designed as a three armed study with either cobalt-chrome or oxidized zirconium femoral heads articulating against highly cross-linked polyethylene (XLPE) liners and oxidized zirconium articulating against ultra-high molecular weight polyethylene (UHMWPE). Early reports that XLPE was significantly superior to UHMWPE when coupled with cobalt-chrome meant no patient involved in the study was approved to receive a couple of cobalt-chrome and UHMWPE since it was deemed to be a high wear group. We hypothesised that oxidized zirconium femoral heads would produce less linear wear than cobalt- chrome femoral heads at mid-term evaluation, whilst maintain similar outcomes when recording WOMAC, SF-36 and pain scores, and complication rates. All three groups were statistically comparable preoperatively and at five years when measuring normalised WOMAC, SF-36 and pain scale scores; all groups showed a statistically significant improvement in scores from baseline compared to at five years (p<0.001). There was no significant difference in mean femoral head penetration when either oxidized zirconium or cobalt-chrome where articulated with XLPE (p=0.1533) but a significant difference in mean femoral head penetration was observed between the group that had used UHMWPE and both the other groups which had used XLPE (p<0.001). There were no hips in which either acetabular or femoral osteolysis was observed. We have demonstrated that oxidized zirconium femoral heads are safe with low rates of wear when coupled with XLPE. However at five year follow-up, it appears that the choice of material of the acetabular bearing is more important than the choice of femoral head bearing. Further follow-up is needed in order to see if femoral head choice leads to a difference in outcome beyond 5 years as laboratory data suggests. Moreover the potential reduction of corrosion with ceramic or oxidized zirconium heads may yet also prove to be significant. It is likely that current and future data will lead us away from the use cobalt chrome heads towards alternatives that are less likely to be associated with corrosion or wear and osteolysis


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 125 - 125
1 Jan 2016
Moussa M Esposito C Elpers M Wright T Padgett DE
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 133 - 133
1 Feb 2017
Gascoyne T Turgeon T
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_8 | Pages 19 - 19
1 Apr 2017
Corrado P Alan P Michael S
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Background. As the number of ceramic THR bearings used worldwide is increasing, the number of implants that experience off-normal working conditions, e.g. edge loading, third bodies in the joint, soft tissues laxity, dislocation/subluxation of the joint, increases too. Under all such conditions the bearing surfaces can be damaged, leading eventually to a limitation of the expected performances of the implant. Methods. We characterised the damage resistance of different bearing surfaces (alumina matrix composite BIOLOXdelta, alpha-alumina BIOLOXforte, zirconia 3Y-TZP, oxidized zirconium alloy Zr-2.5Nb, CoCr-alloy) by scratch tests performed following the European standard EN 1071–3:2005. Also the scratch hardness of same materials has been assessed. Results. The Lc1 value (i.e., the load for the onset of a scratch) measured for BIOLOXdelta is about fivefold the one measured for the oxidized zirconium alloy (OXZr) surface and about tenfold the Lc1 measured for the CoCr alloy. The height of ridges along the scratch edges due to plastic flow in the composite ceramic BIOLOXdelta are only 21% in height than in CoCr, and only a small fraction (0.04%) of the height of ridges measured on OXZr surfaces. The scratch hardness of the metal samples tested (CoCr, OXZr) results one order of magnitude lower than the ones of ceramics. This behavior is not influenced by of the presence of the coating on OXZr surface. Conclusions. The transformation toughened ceramics tested (BIOLOXdelta, 3Y-TZP) are the materials that exhibit the higher resistance to scratching. Ridges at scratch edges are lower in ceramics than in coated or uncoated metals. The result show the superior scratch resistance behavior of toughened ceramics for THR wear couples with respect to coated or bare alloys. Level of Evidence. Level 1


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 17 - 17
1 Jun 2012
Burnell C Brandt J Petrak M Bourne R
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Wear of the polyethylene (PE) insert in total knee replacements can lead to wear-particle and fluid-pressure induced osteolysis. One major factor affecting the wear behaviour of the PE insert in-vivo is the surface characteristics of the articulating femoral components. Contemporary femoral components available in Canada are either made of cast Cobalt Chromium (CoCr) alloy or have an oxidized zirconium surface (Oxinium). The latter type of femoral components have shown to have increased abrasive wear resistance and increased surface wettability, thus leading to reduced PE wear in-vitro compared with conventional cast CoCr components. Although surface damage has been reported on femoral components in general, there have been no reports in the literature as to what extent the recommended operating techniques affect the surface tribology of either type of femoral component. Twenty-two retrieved total knee replacements were identified with profound surface damage on the posterior aspect of the femoral condyles. The femoral components were of three different knee systems: five retrievals from the NexGen(r) total knee system (Zimmer Inc., Warsaw, IN), twelve retrievals from the Genesis II(r) total knee system (CoCr alloy or Oxinium; Smith & Nephew Inc., Memphis, TN), and five retrievals from the Duracon(r) total knee system (Stryker Inc., Mahwah, NJ). Reasons for revision were all non-wear-related and included aseptic loosening in two cases, painful flexion instability, and chronic infection. All retrieved femoral components showed evidence of surface damage on the condyles, at an average of 99° flexion (range, 43° – 135° flexion). Titanium (Ti) alloy transfer and abrasive surface damage were evident on all retrieved CoCr alloy femoral components that came in contact with Ti alloy tibial trays. Surface damage on the retrieved Oxinium femoral components was gouging, associated with the removal and cracking of the oxide and exposure of the zirconium alloy substrate material. CoCr alloy femoral components that had unintended contact with CoCr alloy tibial trays also showed evidence of gouging and abrasive wear. All femoral components showed severe surface damage in the posterior aspect of the condyles. The femoral surface was heavily scratched and the oxidized zirconium coating surface appeared removed. The surface analysis suggested that the surface damage most likely occurred during the time of initial implantation. In particular, it appeared that the femoral condyles were resting on the posterior aspect of the tibial tray in flexion, thus scratching the femoral components. Such scratches could potentially lead to accelerated PE insert wear and reduced implant longevity, thus making expensive revisions surgery necessary. The authors strongly suggest a revision of the current operating techniques recommended by the implant manufacturer to prevent this type of surface damage from occurring


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 141 - 141
1 Jul 2020
Delisle J Benderdour M Benoit B Giroux M Laflamme GY Nguyen H Ranger P Shi Q Vallières F Fernandes J
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Total Knee Arthroplasty (TKA) patients may present with effusion, pain, stiffness and functional impairment. A positive metal hypersensitivity (positive LTT) may be an indication for a revision surgery with a custom-made implant devoid of any hypersensitivity-related metal or an implant with the least possible ion content of the metal hypersensitivity, if no custom-made is available. The purpose of the current study is to assess the prevalence of metal hypersensitivity in subjects requiring a primary TKA and assess their early functional outcomes. We are recruiting 660 subjects admitted for TKA. Subjects are randomly assigned to 2 groups: oxidized zirconium implant group or cobalt-chrome implant group. Functional outcomes and quality of life (QoL) are measured pre operatively, 3, 6 and 12 months post operatively with WHOQOL-BREF (domain1-Physical Health, domain 2- Psychological, domain 3- Social relationships, domain 4-Environment), KSS, KOOS and pain Visual Analog Scale (VAS). LTT and metal ions are evaluated pre operatively and 12 months post-surgery. One hundred-sixty patients, 98 women, were enrolled in the study. Mean age was 65.6±8.9. Mean follow up (FU) was 7.1±3.8 months. Eighty-one (50.6%) were randomised in the cobalt-chrome group. Infection rate was 1.9%, one patient required debridement. Three patients (1.9%) presented with contracture at three months FU. At 12 months, WHOQOL-BREF domain 1, 2 and 4 improved significantly (p0,05). Overall, all 160 patients improved their functional outcomes and QoL. At 12 months, VAS scores decreased from 7±2.06 at baseline to 1.95±2.79. Furthermore, the high prevalence of positive LTT (27/65) do not seem to affect early functional outcomes and QoL on patients that may have received a potential implant with hypersensitivity (18/27)


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 13 - 13
1 Aug 2020
Atrey A Wu J Waddell JP Schemitsch EH Khoshbin A Ward S Bogoch ER
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The purpose of this investigation is to assess the rate of wear the effect once the “bedding in period”/ poly creep had been eliminated. Creep is the visco-elastic deformation that polyethylene exhibits in the first 6–12 weeks. We also assessed the wear pattern of four different bearing couples in total hip arthroplasty (THA): cobalt-chrome (CoCr) versus oxidized zirconium (OxZir) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) versus highly-crosslinked polyethylene (XLPE) acetabular liners. This was a randomized control study involving 92 patients undergoing THA. They were randomized to one of four bearing couples: (1) CoCr/UHMWPE (n= 23), (2) OxZir/UHMWPE (n=21), (3) CoCr/XLPE (n=24), (4) OxZir/XLPE (n=24). Patients underwent a posterior approach from one of three surgeons involved in the study. All patients received a porous-coated cementless acetabular shell and a cylindrical proximally coated stem with 28 mm femoral heads. Each patient was reviewed clinically and radiographically at six weeks, three and 12 months, two, five and 10 years after surgery. Standardized anteroposterior and lateral radiographs were taken. All polyethylene wear was measured by an independent blinded reviewer. Linear and volumetric wear rates were measured on radiographs using a validated computer software (Polyware Rev. 5). Creep was defined as the wear at 6 or 12 weeks, depending on if there was a more than 10% difference between both measurements. If a greater than 10% difference occurred than the later period's wear would be defined as creep. 72 hips were included in analysis after exclusion of seven revisions, three deaths and 10 losses to follow-up. The annual linear wear rates (in mm/y) at 10 years were (1) 0.249, (2) 0.250, (3) 0.074 and (4) 0.050. After adjusting for creep these rates become were (1) 0.181, (2) 0.142, (3) 0.040 and (4) 0.023. There is statistical differences between raw and adjusted linear wear rates for all bearing couples. The percentage of the radiographically measured wear at 10 years due to creep is (1) 30% (2) 44%, (3) 58.5% and (4) 51.5% with significant differences in couples with XLPE versus those with UHMWPE. There was no significant correlation between age, gender, cup size, tilt, planar anteversion and the linear or volumetric wear rates. The linear wear rate of both UHMWPE and XLPE are even lower thxdsxzan previously described when creep is factored out. XLPE has again demonstrated far superior linear wear rates at 10 years than UHMWPE. There were no significant differences in wear rate at 10 years between CoCr and OxZir, this may be due to an underpowered study. XLPE exhibits proportionally more creep than UHMWPE within the first 6–12 weeks and accounts for more of the total wear at 10 years as measured radiographically at the end period


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 42 - 42
1 Oct 2018
McCalden RW Clout A Naudie DD MacDonald SJ Somerville LE
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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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 66 - 66
1 Mar 2017
MacLean C Lanting B Vasarhelyi E Naudie D McAuley J Howard J McCalden R MacDonald S
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Background. The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations. Methods. A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidized zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the center index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts. Results. A total of 75 patients underwent RSA analysis. 20 patients with a ceramic femoral head component and 16 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.32 vs. 0.28 mm/year, p=0.427) and ceramic vs cobalt chrome cohorts (0.28 vs. 0.22 mm/year, p=0.202) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p =023). Conclusion. This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort. Level of Evidence – Level II. Disclosures - Institutional support provided by Depuy, Stryker, and Smith and Nephew


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 14 - 14
1 Jan 2016
Al-Khateeb H Teeter M Naudie D McCalden RW
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 137 - 137
1 Mar 2013
Brandt J Guenther L O'Brien S Vecherya A Turgeon T Bohm E
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Femoral components with an oxidized zirconium-niobium (OxZr) gradient ceramic surface (Oxinium, Smith & Nephew, Memphis, TN) were introduced as an alternative to cobalt-chromium (CoCr) alloy femoral components for the purpose of PE wear reduction in total knee replacements [1]. In the present study, the surface damage and clinical performance of both CoCr alloy and OxZr femoral components were investigated. By matching CoCr alloy and OxZr femoral components for clinical factors, as done by Heyse et al. [2], the surface damage on retrieved CoCr alloy and OxZr femoral component was assessed. Twenty-six retrieved cobalt-chromium (CoCr) alloy femoral components were matched with twenty-six retrieved oxidized zirconium (OxZr) femoral components for implantation period, body-mass index, patient gender, implant type (cruciate ligament retaining/substituting), and polyethylene insert thickness. Detailed surface profilometry was performed on retrieved femoral condyles in areas that had not been damaged by gouging [3] with the specific purpose of investigating the in vivo wear behaviour of undamaged OxZr surface. In addition, the cumulative survivorships were calculated for patients who had received CoCr alloy or OxZr femoral components from our orthopaedic database. In order to identify factors that affect the clinical performance of CoCr alloy and OxZr femoral components, the findings from the retrieval analysis and the survivorship analysis were combined. The Rp, Rpm, and Rpk-values for the retrieved CoCr alloy femoral components were found significantly higher than the Rp, Rpm, and Rpk-values for the retrieved OxZr femoral components (p ≤ 0.031). The roughness parameters values (Ra, Rq, Rz, Rp, Rpm, Rpk, Rv, and Rsk) for the retrieved CoCr alloy femoral components were found significantly higher than the values of the new, never implanted CoCr alloy femoral components (p ≥ 0.001). The surface roughness was higher on the medial condyles than the lateral condyles of the retrieved CoCr alloy femoral components; such a difference was not observed on the retrieved OxZr femoral components. The OxZr bearing surface appeared to protect the femoral components from abrasive wear in vivo. At 8.5-years follow up, the cumulative survivorship for the CoCr alloy femoral components (98%) was not found to be statistically significantly different (p = 0.343, Breslow test) from the OxZr femoral components (97.5%). Therefore, OxZr femoral components appeared to possess low wear characteristics and could be particularly suitable for younger, heavier patients to ensure long-term durability


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 105 - 105
1 May 2012
Pinczewski L Miller C Salmon L Williams H Walsh W
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The aim of this study was to compare the outcome of cemented TKR using either oxidized zirconium (oxinium) or cobalt chrome (CoCr) femoral components in patients undergoing simultaneous bilateral TKR. Patients involved in the study received one of each prosthesis, thereby acting as their own control. The hypothesis was that there would be no difference in the clinical and radiographic outcome between the two prosthetic materials. Forty consecutive patients who were undergoing bilateral Genesis ll TKR consented to participate in the study. Patients were assessed preoperatively, at five days, six weeks and one, two and five years, postoperatively. The outcome measures included the KOOS, Knee Society Score, BOA Patient Satisfaction Scale, and radiographs at six weeks and one, two and five years. In two patients polyethlylene exchange was performed at 56 months from surgery during patellofemoral resurfacing. The four retrieved polyethylene liners were studied for wear with the aid of a stereo zoom microscope and an environmental scanning electron microscope (ESEM). Both the patients and the all examiners were blinded as to the prosthesis type throughout the study. Forty patients (80 knees) were included in the study. At five years, three patients were deceased and two had developed senile dementia. No patients were lost to follow up. At five years from surgery the CoCr knee was preferred by 41% of patients compared to 13% who preferred the Oxinium knee (p=0.009). There was no significant difference in range of motion between the two prosthesis at five days, six weeks or one, two and five years. There were also no significant differences between the two prostheses in any of the other variables assessed. The four retrieved polyethylene inserts showed similar patterns of wear in terms of both wear types and patterns under examination with both the stereo zoom and scanning electron microscope with no clear differences between CoCr and Oxinium bearing against the polyethlylene. There was no difference in the grade or incidence of radiographic lucencies between the two prosthesis at five years. At five years after surgery the only significant difference between the Genesis II Oxinium prosthesis and the CoCr prosthesis was a subjective preference for the CoCr prosthesis by a higher proportion of patients. There were no unexpected complications associated with the use the Oxinium femoral implants. In the four retrieved polyethylene liners, no significant differences were identified between the two prosthesis materials in terms of detectable wear type and patterns. Continued follow up of this cohort is planned to establish whether Oxinium femoral implants have an improved survivorship compared to CoCr femoral component in total knee replacement to warrant the additional cost


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 567 - 568
1 Nov 2011
McCalden RW Naudie DD Bourne RB MacDonald SJ Holdsworth DW Yuan X Charron KD
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Purpose: Efforts to decrease polyethylene wear have lead to advances in polyethylene and counter-face technology for total hip replacement. In particular, the use of highly cross-linked polyethylene (XLPE) and more recently, oxidized zirconium (Oxinium) heads, have demonstrated significant in-vitro improvements in THR wear. This study reports on the early clinical performance and wear (measured with RSA) of an randomized controlled trial (RCT) comparing Oxinium and CoCr heads on XLPE and conventional polyethylene (CPE). Method: Forty patients were enrolled in a RCT and stratified to receive either an Oxinium (Ox) or CoCr head against either XLPE or CPE (ie 10 patients in each group). All patients had otherwise identical THRs and had tantalum beads inserted in the pelvis and polyethylene for wear analysis. There were no significant differences between groups with respect to patient demographics and the average age was 68 years (range 57–76) at index procedure. RSA wear analysis was performed immediately post-op, at six weeks, three and six months and then at one and two years. All patients are a minimum of four years post-op (average 4.6, range 4 – 5.8). Patients were followed prospectively using validated clinical outcome scores (WOMAC, SF-12, Harris Hip scores) and radiographs. Results: All health-related outcomes were significantly improved from pre-operative with a mean Harris Hip score and WOMAC at last follow-up of 90.9 and 80.2, respectively. Total 3D femoral head penetration at two years for each group were the following: CoCrXLPE (0.068±0.029mm); OxXLPE (0.115±0.038mm); CoCrCPE (0.187±0.079mm); and OxCPE (0.242±0.088mm). Thus, OxCPE was significantly higher than OxXLPE and CoCrXLPE but not CoCrCPE (p=0.001, p> 0.0001 and p=0.094, respectively). In other words, head penetration was higher with CPE compared to XLPE but there was no significant difference between Ox and CoCr heads. Similarily, regardless of head type (ie combining similar poly types), there was a significant difference in 3D head penetration at two years between CPE and XLPE ( CPE 0.213±0.086; XLPE 0.093±0.041, p> 0.0001). Conclusion: The early results of this RCT, using RSA as the wear analysis tool, indicate a significant improvement in wear with XLPE compared to CPE. However, it failed to show a clear advantage to the use of Oxinium over CoCr against either polyethylene. Longer follow-up is required to determine steady-state wear rates (after bedding-in) and allow comparison between bearing groups


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 97 - 97
1 Mar 2006
Lee J Maruthainar K Wardle N Haddad F Blunn G
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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


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 260 - 260
1 Dec 2013
Cartner J Aldinger P Fessenden M Li C
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INTRODUCTION:. The use of tapered junctions in primary hip arthroplasty has excellent results. Large heads are being used to mitigate dislocation and optimize range of motion. The prevalence of larger heads, coupled with recent findings regarding corrosion artifacts at tapered surfaces, has spurred growing interest when considering revision rates. The purpose of this study was to determine if correlations exist between severity of corrosion artifacts and head size, head offset, time in vivo, orhead material in a 15 year retrieval database. METHODS:. Retrieved hip arthroplasty devices with CoCrMo or oxidized zirconium (OxZr) heads were investigated for corrosion artifacts in this study. Female tapered surfaces were scored independently by a panel according to the Goldberg system for assessment of corrosion. Exclusion criteria included less than 1 week in vivo, ceramic taper, and modular proximal stem sleeves. Evaluation was performed on only stem/head taper junctions. SEM analyses and a newly developed method of vertical straightness deviation (VSD) were used on a subset of devices as an additional measure to quantify corrosion within the taper contact region by measuring depth of material loss. RESULTS:. A total of 227 retrievals containing taper surfaces spanning 15 years were evaluated. Of these, 183 met the inclusion criteria (CoCrMo, n = 159; OxZr, n = 24). Time in vivo ranged from 1 week to 10 years. The majority of the head tapers were 12/14 in size. There was no correlation between head size and average Goldberg score (n = 183, R. 2. = 0.23). There was a parabolic correlation between head offset (9 offset sizes evaluated) and average Goldberg score (n = 156, R. 2. = 0.89), with the more negative offsets and the more positive offsets exhibiting higher scores. There was no correlation between time in vivo and Goldberg score (n = 104, R. 2. = 0.11). There was a correlation between head material and Goldberg score, with OxZr having a lower score as compared to CoCrMo heads (1.9 ± 0.6 vs. 2.5 ± 0.9, p = 0.002). VSD measurements made on CoCrMo heads with a Goldberg score of 4 showed that 5 of 6 CoCrMo heads had a measureable depth of material loss at the taper, with a maximum depth ranging from 8 to 103 microns. There were no OxZr heads with a Goldberg score of 4. SEM and VSD measurements corroborated scoring (Figures 1–3). CONCLUSIONS:. CoCrMo heads have 20+ years of clinical success, but as shown in this study may still generate a quantifiable amount of taper corrosion. Though impaction force, taper cleanliness, patient factors and other myriad multi-factorial issues may contribute to taper corrosion, in this study no correlation was observed for head size or time in vivo and Goldberg score. A correlation was found between head offset and Goldberg score. The use of an OxZr head material exhibited decreased corrosion by-products as compared to the traditional CoCrMo head material used in hip arthroplasty


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 412 - 412
1 Nov 2011
Kim Y Kim J Huh W Lee K
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Although total knee arthroplasty (TKA) has been a reliable procedure providing durable pain relief, polyethylene (PE) wear remains a major limitation of the long-term success of TKA. One potential method of lowering PE wear in TKA is to use oxidized zirconium (OxZr)-bearing surface. Although wear simulating testing of an OxZr counter surface of femoral component produced less PE wear and fewer particles than did cobalt-chrome (Co-Cr) counter surface of femoral component [1–4], this finding has not been demonstrated in vivo to our knowledge. We measured in vivo PE wear by isolating and analyzing PE wear particles in synovial fluid from wellfunctioning TKA [5]. The purpose of the current study was to determine the size, shape, and amount of PE wear particles isolated from synovial fluid of patients who underwent a bilateral simultaneous TKA prosthesis, but different materials of femoral components. We performed a bilateral simultaneous TKA in 100 patients (200 knees) who received an OxZr femoral component in one knee and a Co-Cr femoral component in the other. Mean age was 55.6 (44–60) years. Synovial fluid was obtained from 28 patients (56 knees) who had undergone a simultaneous bilateral TKA under completely sterile conditions at one or two years after the operation. Randomization to an OxZr or Co-Cr femoral component was accomplished with use of a sealed study number envelope, which was opened in the operating room before the skin incision had been made. After the opening the randomization envelope, the first knee received prosthesis indicated by the envelope (OxZr or Co-Cr component) and the contralateral (second TKA) knee received the other prosthesis (OxZr or Co-Cr component). All operations were performed by one surgeon using the same design of total knee prosthesis: Genesis II (Smith and Nephew, Memphis, Tennessee). Only the material of the femoral component differed between two groups. The preoperative diagnosis was osteoarthritis in all patients. Preoperative and post operative KS and HSS knee scores, KS functional scores and UCLA activity scores were evaluated. The amount of polyethylene wear particles in the aspirated synovial fluid sample was analyzed by thermogravimetic analysis (TGA) using a TGA instrument (TGA/SDTA 84le model, Mettler Toledo CO., Greifensee, Switzerland). The weight of the sample solution was measured before and after removing the organic content by heating the sample solution. The sample solution was casted onto petri dishes. The petri dish was covered and kept in a dry oven at 60°C for 2 days. While the sample solution was kept in a dry oven for 2 days, a small hole was made on the cover of the petri dish to allow water to evaporate slowly for 2 days. After this procedure, the cover of petri dish was removed and TGA sample was dried at 60°C for another 2 days. After the sample was completely dried out, the dried sample was measured using analytical balance. TGA was used to determine the weight change profiles of polyethylene subject to heating under a nitrogen atmosphere. The nitrogen flow rate was kept constant at 50mL per minute. TGA data were taken at heating rate as 5°C per minute in the temperature range of 20° to 1000°C. The weight loss data were recorded as a function of time and temperature using special software in computer. When the temperature reached to the point of decomposition of the sample, the sample started to lose weight. By calculating the weight of the sample around the temperature which led to start to decomposition, real amount of polyethylene in the sample was measured. The size and shape of PE particles were examined using scanning electron microscopy (JSH-6360A model, Jeol Co., Tokyo, Japan). The samples were coated using a platinum sputtering machine for 20 sec. ANOVA, nonparametric chi square test, nonpaired t-test and Mann-Whitney U-test were used for statistical analyses. Differences of P< 0.05 were considered statistically significant. Mean preoperative KS (27.5 vs 27.2 points) scores, HSS (51.1 vs 51.2 points) knee scores, KS functional scores (55.4 vs 55.4 points) and UCLA activity scores (2.8 vs 2.8 point) were not significantly different between two groups. Mean postoperative KS (93 vs 92 points), HSS knee scores (90 vs 89 points), KS functional scores (78 vs 78 points), and UCLA activity scores (7.8 vs 7.8) were not significantly different. Mean weight of the polyethylene particles was 0.0219 g (SD, 0.0058) in the Co-Cr femoral component groups and it was 0.0214 g (SD, 0.005) in the OxZr group. This difference was not significant (P=0.711139, paired t-test). The size of particles was not different between the two groups. Also, shape of particles was not different between the two groups. Under the condition and the duration of this study in this specific group of patients, TKA with OxZr or Co-CR femoral knee component had excellent clinical and radiographic outcomes with no osteolysis. While the wear simulator test in vitro demonstrated significant decrease in PE particles in the knees with an OxZr femoral component, our study in vivo revealed that total particle weight, size, and shape of PE wear particles were similar in the knees with an OxZr femoral component and in those with a Co-Cr femoral component


Bone & Joint Open
Vol. 2, Issue 10 | Pages 785 - 795
1 Oct 2021
Matar HE Porter PJ Porter ML

Aims

Metal allergy in knee arthroplasty patients is a controversial topic. We aimed to conduct a scoping review to clarify the management of metal allergy in primary and revision total knee arthroplasty (TKA).

Methods

Studies were identified by searching electronic databases: Cochrane Central Register of Controlled Trials, Ovid MEDLINE, and Embase, from their inception to November 2020, for studies evaluating TKA patients with metal hypersensitivity/allergy. All studies reporting on diagnosing or managing metal hypersensitivity in TKA were included. Data were extracted and summarized based on study design, study population, interventions and outcomes. A practical guide is then formulated based on the available evidence.