Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6 8036 Graz, Austria; Department of Dentistry and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz, Billrothgasse 4, 8010 Graz, Austria..
Department of Orthopaedics and Traumatology, Medical University of Graz, Auenbruggerplatz 5/6 8036 Graz, Austria.
Injury. 2022 Mar;53(3):1283-1288. doi: 10.1016/j.injury.2021.10.025. Epub 2021 Oct 30.
Ankle is the most common site of hardware removal, mainly performed within 12 months of the primary surgery. The prominence of the metallic hardware is a frequent cause of pain after fracture fixation. Over the last decade, the development of bioresorbable materials based on magnesium (Mg) has increased. Bioresorbable metals aim to avoid a second surgery for hardware removal.
Twenty patients with isolated, bimalleolar, or trimalleolar ankle fractures were treated with bioresorbable screws made of Mg, 0.45wt% calcium (Ca) and 0.45wt% zinc (Zn) (ZX00). Patient-reported outcome measures (PROMs) including visual analogue scale (VAS) for pain, the presence of complications 6 and 12 months after surgery and the AOFAS scale after 12 months were reported. The functional outcomes were analysed through the range of motion (ROM) of the ankle joint with a standard goniometer. Degradation products and the bioresorbability of the screws were evaluated using plane radiographs.
One patient was lost to follow-up. All patients were free of pain, no complications, shoe conflict or misalignement were reported after 12 months of follow-up. No Mg screws were surgically removed. An additional fixation of the distal fibula or the dorsal tibial fragment with conventional titanium implants (Ti) was performed in 17 patients. Within 12 months after primary refixation, 12 of these patients (71%) underwent a second surgery for Ti hardware removal. The mean AOFAS score was 89.8±7.1 and the difference between the treated and the non-treated site in the ROM of the talocrural joint was 2°±11° after 12 months. Radiolucent areas around the screws were attributed to degradation and did not affect clinical or functional outcomes. After one year, the Mg screw heads could not be detected in the plane radiographs of 17 patients which suggests that the majority of the screw head is degraded without introducing adverse reactions.
At 6 and 12 months, the bioresorbable Mg screws show excellent PROMs without complications or need for screw removal. The resorbability of the screw heads in most of the patients after one year could also provide an advantage over conventional bio-inert implants by avoiding related skin irritation due for instance to shoe conflict.
踝关节是最常见的去除内固定物的部位，主要在初次手术后 12 个月内进行。金属内固定物的突出是骨折固定后疼痛的常见原因。在过去十年中，基于镁 (Mg) 的可生物吸收材料的发展有所增加。可生物吸收金属旨在避免第二次进行内固定物去除手术。
20 例孤立性、双踝或三踝踝关节骨折患者接受了由 0.45wt%钙 (Ca) 和 0.45wt%锌 (Zn) 制成的可生物吸收 Mg 螺钉 (ZX00) 治疗。报告了包括疼痛视觉模拟评分 (VAS) 在内的患者报告的结局测量 (PROM)、术后 6 个月和 12 个月的并发症以及 12 个月后的 AOFAS 评分。使用标准量角器分析踝关节活动度 (ROM) 来评估功能结果。通过平面射线照相评估降解产物和螺钉的可生物吸收性。
1 例患者失访。所有患者在随访 12 个月后均无疼痛，无并发症，无鞋冲突或错位。没有 Mg 螺钉需要手术取出。17 例患者中有 17 例在腓骨远端或胫骨背侧碎片处额外使用传统钛植入物 (Ti) 固定。在初次复位后 12 个月内，其中 12 例 (71%) 因 Ti 内固定物去除而行第二次手术。平均 AOFAS 评分为 89.8±7.1，12 个月后距骨-跟骨关节的 ROM 中治疗与未治疗部位之间的差异为 2°±11°。螺钉周围的透光区归因于降解，并不影响临床或功能结果。一年后，17 例患者的平面射线照相中无法检测到 Mg 螺钉头，这表明大多数螺钉头已降解，而没有引起不良反应。
在 6 个月和 12 个月时，可生物吸收的 Mg 螺钉表现出出色的 PROM，无并发症，无需螺钉取出。一年后，大多数患者的螺钉头可吸收，这与传统的生物惰性植入物相比具有优势，因为可避免例如因鞋冲突引起的相关皮肤刺激。
