Aims.
Abstract. Background.
This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA). Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years’ follow-up.Aims
Methods
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.
The purpose of this study was to precisely measure the 10-year polyethylene wear rate of primary total hips using Radiostereometric analysis (RSA) comparing
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.
While
The aim of this study was to evaluate fretting and corrosion in retrieved oxidized zirconium (OxZr; OXINIUM, Smith & Nephew, Memphis, Tennessee) femoral heads and compare the results with those from a matched cohort of cobalt-chromium (CoCr) femoral heads. A total of 28 OxZr femoral heads were retrieved during revision total hip arthroplasty (THA) and matched to 28 retrieved CoCr heads according to patient demographics. The mean age at index was 56 years (46 to 83) in the OxZr group and 70 years (46 to 92) in the CoCr group. Fretting and corrosion scores of the female taper of the heads were measured according to the modified Goldberg scoring method.Aims
Patients and Methods
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. 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.Purpose
Methods
INTRODUCTION. The development of new bearing surfaces for total joint replacement is constantly evolving.
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.
Introduction. The development of new bearing surfaces for total joint replacement is constantly evolving.
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.
Introduction. In Total Hip Arthroplasty (THA), polyethylene wear reduction is key to implant longevity.
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. 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.INTRODUCTION
METHODS
Despite many claims of good wear properties following
total knee replacement (TKR) with an oxidised zirconium (OxZr) femoral
component, there are conflicting clinical results. We hypothesised
that there would be no difference in either the mid-term clinical
and radiological outcomes or the characteristics of the polyethylene
wear particles (weight, size and shape) in patients using an OxZr
or cobalt-chrome (CoCr) femoral component. In all 331 patients underwent
bilateral TKR, receiving an OxZr femoral component in one knee and
a CoCr femoral component in the other. The mean follow-up was 7.5
years (6 to 8). Following aspiration, polyethylene wear particles
were analysed using thermogravimetric methods and scanning electron
microscopy. At the most recent follow-up, the mean Knee Society
score, Western Ontario and McMaster Universities Osteoarthritis
Index score, range of movement and satisfaction score were not significantly
different in the two groups. The mean weight, size, aspect ratio
and roundness of the aspirated wear particles were similar for each
femoral component. Survivorship of the femoral, tibial and patellar
components was 100% in both groups. In the absence of evidence of an advantage in the medium term
we cannot justify the additional expense of an OxZr femoral component.
Introduction.
Large diameter femoral heads offer increased range of motion and reduced risk of dislocation. However, their use in total hip arthroplasty has historically been limited by their correlation with increased polyethylene wear. The improved wear resistance of highly crosslinked UHWMPE has led a number of clinicians to transition from implanting traditionally popular sizes (28mm and 32 mm) to implanting 36 mm heads. Desire to further increase stability and range of motion has spurred interest in even larger sizes (> 36 mm). While the long-term clinical ramifications are unknown, in-vivo measurements of highly crosslinked UHMWPE liners indicate increases in head diameter are associated with increased volumetric wear [1]. The goal of this study was to determine if this increase in wear could be negated by using femoral heads with a ceramic surface, such as oxidized Zr-2.5Nb (OxZr), rather than CoCrMo (CoCr). Specifically, wear of 10 Mrad crosslinked UHMWPE (XLPE) against 36 mm CoCr and 44 mm OxZr heads was compared. Ram-extruded GUR 1050 UHMWPE was crosslinked by gamma irradiation to 10 Mrad, remelted, and machined into acetabular liners. Liners were sterilized using vaporized hydrogen peroxide and tested against either 36 mm CoCr or 44 mm OxZr (OXINIUM(tm)) heads (n=3). All implants were manufactured by Smith & Nephew (Memphis, TN). Testing was conducted on a hip simulator (AMTI, Watertown, MA) as previously described [2]. The 4000N peak load (4 time body weight for a 102 kg/225 lb patient) and 1.15 Hz frequency used are based upon data obtained from an instrumented implant during fast walking/jogging and have previously been shown to generate measurable XLPE wear [2,3]. Lubricant was a serum (Alpha Calf Fraction, HyClone Laboratories, Logan, UT) solution that was replaced once per week [2]. Liners were weighed at least once every million cycles (Mcycle) over the duration of testing (∼ 5 Mcycle). Loaded soak controls were used to correct for fluid absorption. Single factor ANOVA was used to compare groups (a = 0.05).Introduction
Materials and Methods
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.