Abstract
Introduction
The release of metallic debris can promote many adverse tissue reactions, as metallosis, necrosis, pseudotumors and osteolysis 1–3. This debris is mainly generated by the fretting-corrosion mechanism due to the geometric difference in the head-stem interface 4. Retrieval and in silico analysis showed the roughness of the stem-head interface appears to play an important role in the volume of material lost and THA failure 5–7. The technical standard ISO 7206-2 recommends the measurement of average roughness (Ra) and max height of the profile (Rz) to control the quality of the surface finish of articulating surfaces on THA implants. However, despite the importance of the trunnion roughness, there is no specific requirement for this variable on the referred technical standard. The present study carried out a surface finish analysis of the trunnion of hip stems from five distinct manufacturers.
Methods
Four stems (n = 4) from five (5) distinct manufacturers (A, B, C, D, and E) were used to evaluate the roughness of the trunnion. All the stems are similar to the classical Exeter stem design, with a 12/14 taper and a polished body surface.
The roughness of trunnions was evaluated according to ISO 4287 and ISO 13565-2. The total assessment length was 4.8 mm with 0.8 mm cut-off. The first and last 8.33% of assessment length were not considered. The measurements of all samples were made in a rugosimeter with 2 µm feeler ITP (Völklingen, Germany), the velocity of 0.5 mm.s-1, and a force of 1.5 mN. The calibration was made at 20 ºC and relative humidity at 50%.
The Kruskal Wallis with post hoc Nemenyi test was used to evaluate the difference of Ra among the manufacturers. The confidence level was set at 5%.
Results and Discussion
The analysis of surface finish revealed different roughness among the manufactures (p < 0.005), with Ra between 0.061 µm to 3.184 µm and Rz varying of 0.41 µm to 12.69 µm. The manufacturers A and E had a Ra (2.587±0.050 µm and 3.146±0.031µm) of the trunnion similar to founded by Panagiotidou et al (2013). Within such range, the trunnion has shown a high presence of pit 8. The manufacturer C, on the other hand, had the best surface finish of the trunnion (Ra = 0.069±0.010 µm and Rz = 0.505 ± 0.076 µm). This more smooth surface might increase the taper strength, reduce the shear stress and the susceptibility to the fretting-corrosion damage 4,8.
Conclusion
The results were worrying because there is great variability of roughness among the manufacturers with the occurrence of trunnions with roughness too high. Nevertheless, the ISO technical standard does not recommend any procedure or minimum parameters acceptable for the surface finish of the trunnion. The revision of ISO 7206-2 would guarantee better control of trunnion roughness to reduce the amount of metallic debris and increase the safety of THA implants. Additional research is needed to determine a target value for this variable.
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