Orthopaedic Reconstruction and Children's Orthopaedics, Aarhus University Hospital, Aarhus.
Department of Clinical Medicine, Aarhus University, Aarhus.
Acta Orthop. 2021 Aug;92(4):479-484. doi: 10.1080/17453674.2021.1903278. Epub 2021 Mar 24.
Background and purpose - Observing serious adverse events during treatment with the Precice Stryde bone lengthening nail (NuVasive, San Diego, CA, USA), we conducted a nationwide cross-sectional study to report the prevalence of adverse events from all 30 bone segments in 27 patients treated in Denmark.Patients and methods - Radiographs of all bone segments were evaluated regarding radiographic changes in February 2021. We determined the number of bone segments with late onset of pain and/or radiographically confirmed osteolysis, periosteal reaction, or cortical hypertrophy in the junctional area of the nail.Results - In 30 bone segments of 27 patients we observed radiographic changes in 21/30 segments of 20/27 patients, i.e., 19/30 osteolysis, 12/30 periosteal reaction (most often multi-layered), and 12/30 cortical hypertrophy in the area of the junction between the telescoping nail parts. Late onset of pain was a prominent feature in 8 patients. This is likely to be a prodrome to the bony changes. Discoloration (potential corrosion) at the nail interface was observed in multiple removed nails. 15/30 nails were still at risk of developing complications, i.e., were not yet removed.Interpretation - All Stryde nails should be monitored at regular intervals until removal. Onset of pain at late stages of limb lengthening, i.e., consolidation of the regenerate, should warrant immediate radiographic examination regarding osteolysis, periosteal reaction, and cortical hypertrophy, which may be associated with discoloration (potential corrosion) of the nail. We recommend removal of Stryde implants as early as possible after consolidation of the regenerate.
背景与目的——在使用 Precice Stryde 骨延长钉(美国圣地亚哥 NuVasive 公司)治疗过程中观察到严重不良事件后,我们开展了一项全国性的横断面研究,报告了在丹麦接受治疗的 27 例患者的 30 个骨骼部位的不良事件发生率。
患者和方法——2021 年 2 月,对所有骨骼部位的影像学结果进行评估,观察是否出现影像学变化。我们确定了多少骨骼部位出现钉尾区域的迟发性疼痛和/或影像学证实的骨溶解、骨膜反应或皮质肥厚。
结果——在 27 例患者的 30 个骨骼部位中,我们观察到 20 例患者中的 21 个骨骼部位(即 30 个骨骼部位中的 19 个发生骨溶解,30 个骨骼部位中的 12 个发生骨膜反应[最常见为多层],30 个骨骼部位中的 12 个发生钉尾区域皮质肥厚。8 例患者出现迟发性疼痛,这可能是骨骼变化的前驱症状。在多个取出的钉中观察到钉界面变色(潜在腐蚀)。15 个骨骼部位仍有发生并发症的风险,即尚未取出。
结论——所有 Stryde 钉都应定期监测,直到取出。肢体延长的后期阶段(即再生骨的愈合)出现疼痛,应立即进行影像学检查,以观察骨溶解、骨膜反应和皮质肥厚的情况,这可能与钉的变色(潜在腐蚀)有关。我们建议在再生骨愈合后尽早取出 Stryde 植入物。