Hothi Harry, Bergiers Sean, Henckel Johann, Iliadis Alexis D, Goodier William David, Wright Jonathan, Skinner John, Calder Peter, Hart Alister J
The Royal National Orthopaedic Hospital, London, UK.
The Royal London Hospital, Barts Health NHS Trust, London, UK.
Bone Jt Open. 2021 Aug;2(8):599-610. doi: 10.1302/2633-1462.28.BJO-2021-0126.
The aim of this study was to present the first retrieval analysis findings of PRECICE STRYDE intermedullary nails removed from patients, providing useful information in the post-market surveillance of these recently introduced devices.
We collected ten nails removed from six patients, together with patient clinical data and plain radiograph imaging. We performed macro- and microscopic analysis of all surfaces and graded the presence of corrosion using validated semiquantitative scoring methods. We determined the elemental composition of surface debris using energy dispersive x-ray spectroscopy (EDS) and used metrology analysis to characterize the surface adjacent to the extendable junctions.
All nails were removed at the end of treatment, having achieved their intended lengthening (20 mm to 65 mm) and after regenerate consolidation. All nails had evidence of corrosion localized to the screw holes and the extendable junctions; corrosion was graded as moderate at the junction of one nail and severe at the junctions of five nails. EDS analysis showed surface deposits to be chromium rich. Plain radiographs showed cortical thickening and osteolysis around the junction of six nails, corresponding to the same nails with moderate - severe junction corrosion.
We found, in fully united bones, evidence of cortical thickening and osteolysis that appeared to be associated with corrosion at the extendable junction; when corrosion was present, cortical thickening was adjacent to this junction. Further work, with greater numbers of retrievals, is required to fully understand this association between corrosion and bony changes, and the influencing surgeon, implant, and patient factors involved. Cite this article: 2021;2(8):599-610.
本研究旨在展示从患者体内取出的PRECICE STRYDE髓内钉的首次检索分析结果，为这些新推出器械的上市后监测提供有用信息。
我们收集了从6例患者体内取出的10根髓内钉，以及患者的临床数据和X线平片影像。我们对所有表面进行了宏观和微观分析，并使用经过验证的半定量评分方法对腐蚀情况进行分级。我们使用能量色散X射线光谱法（EDS）确定了表面碎屑的元素组成，并使用计量分析来表征可延长连接部位附近的表面。
所有髓内钉均在治疗结束时取出，已达到预期的延长长度（20毫米至65毫米）且再生骨已巩固。所有髓内钉均有腐蚀迹象，局限于螺钉孔和可延长连接部位；1根髓内钉连接部位的腐蚀程度为中度，5根髓内钉连接部位的腐蚀程度为重度。EDS分析显示表面沉积物富含铬。X线平片显示6根髓内钉连接部位周围有皮质增厚和骨质溶解，与这些连接部位腐蚀程度为中度至重度的髓内钉相对应。
我们发现，在骨完全愈合的情况下，存在皮质增厚和骨质溶解的迹象，这似乎与可延长连接部位的腐蚀有关；当存在腐蚀时，皮质增厚与该连接部位相邻。需要进行更多数量的取出物研究，以充分了解腐蚀与骨质变化之间的这种关联，以及涉及的外科医生、植入物和患者因素。引用本文：2021；2（8）：599-610。
