基于影像学技术股骨头坏死病灶范围、血液供应与病理变化关系:诊断性动物实验方案

Assessing the degree of necrotic femoral head, and association of blood supply with pathlogical changes: study protocol for a diagnostic animal trial

背景:目前评价股骨头坏死病灶体积大小的影像学方法有基于X射线的Kerboul角、坏死指数,基于CT、MRI图像三维重建计算股骨头坏死体积等,但各方法的准确度报道不一,尚无一种被广泛接受;同时,并没有研究明确揭示骨坏死病变范围、程度与股骨头血供损害的直接联系。目的:评估各种常用影像技术在不同时期骨坏死病灶评价中的准确性,尝试确立一种更加简便易用的骨坏死病灶临床计算方法。方法:实验为诊断性动物体内实验,在中国大连,大连大学附属中山医院完成。制备激素性股骨头坏死犬模型,通过MRI、CT检查,结合Micro-CT离体标本检测对坏死股骨头病变进行精确评估,结合血管灌注造影及病理检测评价骨坏死发生范围、骨破坏程度与血供变化的关联;同时将结果与临床常用仅基于影像学的骨坏死分期分级标准相比较,以期验证此精确测量方法与传统方法的一致性。实验过程遵循了国际兽医学编辑协会《关于动物伦理与福利的作者指南共识》和本地及国家法规,并遵守《动物实验体内实验研究报告规范指南》(ARRIVE指南)。结果与结论:课题拟建立针对骨坏死不同分期采用不同影像学技术测定以获得准确结果的新理念,将使不同技术能力的医疗机构能够应用获得的影像资料给出相对更准确的骨坏死评估结果,使骨坏死病变分期评价更准确,进而患者有望得到针对评估结果的标准化治疗方案。

BACKGROUND： The imaging methods of evaluating the volume of necrotic femoral head are based on Kerboul angle and necrosis index revealed on X-ray, as well as CT and MRI three-dimensional reconstruction, but the accuracy of each method is different, and none is widely accepted. Additionally, the association of the volum and degree of necrotic femoral head with the status of blood supply to the femoral head remain unclear. OBJECTIVE： To evaluate the accuracy of each imaing method for assessing different stages of femoral head necrosis, and to confirm a convenient method used for measuring the volum of necrotic femoral head. METHODS： This diagnostic in vivo animal trial was finished in the Affiliated Zhongshan Hospital of Dalian University, Liaoning Province, China. The canine models of steroid-induced necrosis of femoral head were prepared, and received CT and MRI examinations, followed by three-dimensional reconstruction combined with Micro-CT to make accurate diagnosis; the degree of necrotic femoral head and its association with the status of blood supply were evaluated through angiography and histopathological examination. All above outcome measures were compared with the Association Research Circulation Osseous to testify the consistency of this precise method with traditional methods. The experiment follows the national guidelines for the Care and Use of Laboratory Animals, and ＂Consensus author guidelines on animal ethics and welfare＂ by the international Association for Veterinary Editors（IAVE）. The article was prepared in accordance with the ＂Animal Research： Reporting of In Vivo Experiments Guidelines＂（ARRIVE Guidelines）. RESULTS AND CONCLUSION： The aim of the study is to obtain a accurate measurement method by detecting different stages of osteonecrosis using different imaging techniques, which enables surgeons make exact diagnosis and clinical stage of osteonecrosis, thus desiging standardized treatment program.