Abstract
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.
Correspondence should be addressed to Diane Przepiorski at ISTA, PO Box 6564, Auburn, CA 95604, USA. Phone: +1 916-454-9884; Fax: +1 916-454-9882; E-mail: ista@pacbell.net