French H G, Cook S D, Haddad R J
J Biomed Mater Res. 1984 Sep;18(7):817-28. doi: 10.1002/jbm.820180712.
This study evaluated the interaction of osteosynthetic plates to adjacent tissue. Eleven patients had 13 plates removed with simultaneous biopsies of the adjacent soft tissue. Four patients had pain localized to the area of the plate and 11 patients had routine removal or removal for fracture nonunion. Each plate was graded on a 0-5 point scale for the amount and severity of corrosion present at the screw-plate interface. The adjacent tissue was fixed in formalin and stained with hematoxylin and eosin. The tissue reaction was graded on a 0-5 point scale based on the inflammatory response. A positive correlation of corrosion and tissue reaction was found that was significant at p less than 0.005 in the asymptomatic group. The other good correlation showed that tissue reaction tends to decrease with time at p less than 0.005. There was no correlation of corrosion with tissue reaction in the symptomatic removal group. All patients with pain adjacent to the plates were relieved by implant removal. The findings suggest that stainless steel is minimally toxic to human tissue in most circumstances and that the toxic products are well tolerated. There was a significant group (4/11) that showed a different pattern of tissue response which did not appear to be toxic response. We do not recommend routine implant removal to prevent metal toxicity; however, there is a group of patients who have pain in the area of the implant that may be caused by an allergic reaction and is relieved by implant removal.
本研究评估了接骨板与相邻组织的相互作用。11名患者移除了13块接骨板，同时对相邻软组织进行活检。4名患者的疼痛局限于接骨板区域，11名患者因常规原因或骨折不愈合而移除接骨板。根据螺钉-接骨板界面处腐蚀的程度和严重性，对每块接骨板进行0至5分的评分。将相邻组织用福尔马林固定，并用苏木精和伊红染色。根据炎症反应，对组织反应进行0至5分的评分。在无症状组中，发现腐蚀与组织反应呈正相关，p值小于0.005时具有显著性。另一个良好的相关性表明，组织反应倾向于随时间降低，p值小于0.005。在有症状的移除组中，腐蚀与组织反应无相关性。所有接骨板附近疼痛的患者通过移除植入物后疼痛缓解。研究结果表明，在大多数情况下，不锈钢对人体组织的毒性极小，且其毒性产物耐受性良好。有一个显著的组（4/11）表现出不同的组织反应模式，这似乎不是毒性反应。我们不建议常规移除植入物以预防金属毒性；然而，有一组患者在植入物区域疼痛，可能由过敏反应引起，移除植入物后疼痛缓解。
