Abstract
Introduction
The complex process of inflammation and osteolysis due to wear particles still is not understood in detail. So far, Ultra-high-molecular-weight-polyethylene (UHMWPE) is the bearing material of choice in knee arthroplasty and revision knee arthroplasty, but there is a growing demand for alternative bearing materials with improved wear properties. Lately, increasing interest developed in the use of natural and carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK).
While there is a lack of data concerning the effects of CFR-PEEK particles on human tissue, the effects of such wear debris in vitro and in animal studies is controversially discussed.
The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris.
The authors hypothesized no difference between the used biomaterials because of similar size parameters of the wear particles in a prior knee simulator study of this implant.
Methods and Materials
Synovial tissue samples of 10 patients while knee revision surgery of a rotating hinge knee implant design (Enduro®, Aesculap, Germany) were achieved. The tibial inserts of this design were made from UHMWPE (GUR 1020), whereas the bushings and flanges are made of CFR-PEEK containing 30% polyacrylonitrile (PAN) based carbon fibers (PEEK-Optima LT1, Invibio Ltd. Thornton-Cleveleys, UK). In a prior in vitro test most of the released CFR-PEEK particles were in a size range between 0.1 and 2μm. The implant survival until revision surgery was 22 (2.5–48 min.-max.) months. As a control synovial tissue out of a patient also got knee revision surgery without any PEEK components.
The tissue was fixed with 4% paraformaldehyde, embedded in paraffin, sliced into 2 µm thick sections
stained with hematoxylin and eosin in a standard process. A modified panoptical staining (preincubation in propylenglycol; >3h; 35°C) was also done which stained the UHMWPE particles turquoise.
The study was approved by the ethics committee of the local university.
Results
Overall, histologically a “wear-type” reaction was seen in the testing and the control group similar as described for other materials in the common literature. In all samples of the testing group the UHMWPE particles were scattered in the tissue similar to the control. Larger UHWMPE particles were incorporated in giant cells. In contrast to these findings, CFR-PEEK particles were not scattered in tissue but located only as conglomerates. In addition, these conglomerates have been found exclusively near to or in vessels. Furthermore, CFR-PEEK particles were collected in macrophages, no CFR-PEEK particles were seen in giant cells.
In conclusion, the hypothesis has to be rejected. Interestingely, different behaviour of UHMWPE and PEEK particles has been found in human synovial tissue. This aspect needs further investigation concerning the cytokine expression and also the surface texture of particles.
Acknowledgement
This study was supported by Aesculap, Germany
