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2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene.

ABSTRACT: Background and purpose - The long-term survival of arthroplasty components may be limited by polyethylene wear-related problems such as periprosthetic osteolysis and aseptic loosening. Highly cross-linked polyethylene (HXLPE) blended with vitamin E was introduced to improve oxidative stability and to avoid long-term embrittlement. This study clinically compares the tribological behavior and clinical outcome of vitamin E blended HXLPE with ultra-high molecular weight polyethylene (UHMWPE) in an isoelastic monoblock cup for uncemented total hip arthroplasty.Patients and methods - In this randomized controlled trial (RCT), 199 patients were included: 102 patients received the vitamin E blended HXLPE cup, 97 patients the UHMWPE cup. Clinical and radiographic parameters were obtained preoperatively, directly postoperative and at 3, 12, and 24 months. Wear rates were compared using the mean linear femoral head penetration (FHP) rate.Results - 188 patients (94%) completed the 2-year follow-up. Mean patient satisfaction was higher in the vitamin E blended HXLPE group (8.9 [1]) than in in the control group (8.5 [2], p = 0.03). The Harris Hip Score (HHS) was higher in the vitamin E blended HXLPE group (95 [8]) than in the control group (92 [11], p = 0.3). The FHP rate was lower in the vitamin E blended HXLPE group: 0.046 mm/year compared with 0.056 mm/year in the control group (p = 0.05). No adverse reactions associated with the clinical application of vitamin E blended HXLPE were observed during follow-up, with an excellent 2-year survival to revision rate of 98% for both cups.Interpretation - This study shows the superior performance of the HXLPE blended with vitamin E acetabular cup with lower linear femoral head penetration rates and better clinical results compared with the UHMWPE acetabular cup after 2 years.

SUBMITTER: van Erp JHJ

PROVIDER: S-EPMC8023900 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and purpose - Backside wear of the polyethylene insert in total knee arthroplasty (TKA) can produce clinically significant levels of polyethylene debris, which can lead to loosening of the tibial component. Loosening due to polyethylene debris could theoretically be reduced in tibial components of monoblock polyethylene design, as there is no backside wear. We investigated the effect of 2 different tibial component designs, monoblock and modular polyethylene, on migration of the tibial component in uncemented TKA. Patients and methods - In this randomized study, 53 patients (mean age 61 years), 32 in the monoblock group and 33 in the modular group, were followed for 2 years. Radiostereometric analysis (RSA) was done postoperatively after weight bearing and after 3, 6, 12, and 24 months. The primary endpoint of the study was comparison of the tibial component migration (expressed as maximum total point motion (MTPM)) of the 2 different implant designs. Results - We did not find any statistically significant difference in MTPM between the groups at 3 months (p = 0.2) or at 6 months (p = 0.1), but at 12 and 24 months of follow-up there was a significant difference in MTPM of 0.36 mm (p = 0.02) and 0.42 mm (p = 0.02) between groups, with the highest amount of migration (1.0 mm) in the modular group. The difference in continuous migration (MTPM from 12 and 24 months) between the groups was 0.096 mm (p = 0.5), and when comparing MTPM from 3-24 months, the difference between the groups was 0.23 mm (p = 0.07). Interpretation - In both study groups, we found the early migration pattern expected, with a relatively high initial amount of migration from operation to 3 months of follow-up, followed by stabilization of the implant with little migration thereafter. However, the modular implants had a statistically significantly higher degree of migration compared to the monoblock. We believe that the greater stiffness of the modular implants was the main reason for the difference in migration, but an initial creep in the polyethylene metal-back locking mechanism of the modular group could also be a possible explanation for the observed difference in migration between the 2 study groups.

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2-year results of an RCT of 2 uncemented isoelastic monoblock acetabular components: lower wear rate with vitamin E blended highly cross-linked polyethylene compared to ultra-high molecular weight polyethylene.

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