Stockheim M, Most-Ehrlein S, Rothschenk H-J, Wirbel R
Facharzt für Orthopädie Medizinprodukte, Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e. V., Essen.
Z Orthop Unfall. 2010 Jan;148(1):44-8. doi: 10.1055/s-0029-1240700. Epub 2010 Jan 7.
The case of a 44-year-old male patient is reported, who was operated 4 years after a cruciate ligament replacement. A nearly completely intact biodegradable screw was removed arthroscopically. The screw dislocated from the tibial canal into the joint and caused damage to the retropatellar cartilage which was treated by debridement and lateral release. A material analysis was done on the explanted screw which showed no material fault. A review of the literature reporting adverse events connected to biodegradable implants was carried out. Nine papers reporting about adverse event are cited. There seem to be three main problems: delayed degradation, foreign body reaction and the filling of graft tunnels with non-ossified tissue. Instructions for the use of biodegradable interference screws were requested from seven manufacturers to compare the given information about the degradation behaviour. The information given on the period of time until the screws would be completely resorbed were heterogeneous, ranging from no specific information about the time span at all up to 24 months. More research is needed to identify the degradation behaviour more precisely and clarify the potential risks connected to biodegradable implants. Their use should be reconsidered critically.
报道了一名44岁男性患者的病例，该患者在交叉韧带置换术后4年接受手术。通过关节镜取出了一枚几乎完全完整的可生物降解螺钉。该螺钉从胫骨管脱位进入关节，导致髌后软骨损伤，通过清创和外侧松解进行治疗。对取出的螺钉进行了材料分析，结果显示没有材料缺陷。对报道与可生物降解植入物相关不良事件的文献进行了综述。引用了9篇报道不良事件的论文。似乎存在三个主要问题：降解延迟、异物反应以及移植隧道被未骨化组织填充。向七家制造商索要了可生物降解干涉螺钉的使用说明，以比较所提供的关于降解行为的信息。关于螺钉完全吸收所需时间给出的信息各不相同，从根本没有关于时间跨度的具体信息到24个月不等。需要进行更多研究以更精确地确定降解行为，并阐明与可生物降解植入物相关的潜在风险。应审慎重新考虑其使用。
