Department of Orthopeadics, Mashhad University of Medical Sciences, Iran.
Arch Iran Med. 2013 Aug;16(8):478-82.
A damaged orthopedic implant in the body can cause problems for the patient and disrupt the therapeutic process. This study investigates various factors for orthopedic implant failures in patients with traumatic lower limb fractures who referred to a trauma center in Mashhad, Iran.
This was a prospective study of 23 patients referred to Kamyab University Hospital with failed orthopedic implants in 2009. We included any patient with an orthopedic device previously implanted secondary to a traumatic lower limb fracture who later presented to Kamyab University Hospital because of a failed implant. For all patients, a thorough history was taken and the necessary investigations that included radiographic studies were performed. We investigated the quality of the failed devices by chemical analysis, metal hardness testing and metallography. The results were statistically analyzed.
The mean age of the patients was 33 ± 19 years. There were 19 (82.5%) male and 4 (17.4%) female patients. In 14 (60.9%) cases, there were failed femoral implants and 9 (39.1%) cases had failed implants for tibial fractures. We compared the implants against ASTM standards. According to chemical analysis, all internally produced devices and one of the leading international brands were within the expected standard. However, in 3 cases chemical analysis showed a deviation from the standards. These were manufactured by "miscellaneous" companies. In one (4.3%) case the device failure was iatrogenic, in 14 (60.9%) it was due to faulty implants and in 8 (34.8%) cases, the patients were non-compliant with instructions. Hardness testing was satisfactory in all cases and metallographic studies showed good quality for the leading international brands, satisfactory quality for the internally produced devices and poor quality for the miscellaneous devices.
The implants classified as miscellaneous were of poor quality. Thus, we cannot recommend their use in orthopedic surgeries. We recommend using credible, known brands.
体内受损的骨科植入物会给患者带来问题，并扰乱治疗过程。本研究调查了伊朗马什哈德创伤中心因创伤性下肢骨折而就诊的患者中骨科植入物失败的各种因素。
这是对 2009 年因骨科植入物失败而转诊至卡米亚布大学医院的 23 名患者的前瞻性研究。我们纳入了任何因创伤性下肢骨折而先前植入骨科器械、后因植入物失败而转诊至卡米亚布大学医院的患者。对所有患者进行了详细的病史采集，并进行了包括影像学研究在内的必要检查。我们通过化学分析、金属硬度测试和金相学研究来检查失败器械的质量。结果进行了统计学分析。
患者的平均年龄为 33 ± 19 岁。19 例（82.5%）为男性，4 例（17.4%）为女性。14 例（60.9%）为股骨植入物失败，9 例（39.1%）为胫骨骨折植入物失败。我们将植入物与 ASTM 标准进行了比较。根据化学分析，所有国产器械和一家领先的国际品牌都符合预期标准。然而，在 3 例中，化学分析显示出偏离标准的情况。这些是由“杂项”公司生产的。在 1 例（4.3%）中，器械失效是医源性的，在 14 例（60.9%）中，是由于植入物故障，在 8 例（34.8%）中，患者不遵守医嘱。所有病例的硬度测试均令人满意，金相研究显示，领先的国际品牌的质量良好，国产器械的质量满意，杂项器械的质量较差。
被归类为杂项的植入物质量较差。因此，我们不能推荐在骨科手术中使用它们。我们建议使用可靠的、知名的品牌。
