Complications of bone-anchored prostheses for individuals with an extremity amputation: A systematic review

BackgroundThis study aimed to provide an overview of device-related complications occurring in individuals with an upper or lower extremity amputation treated with a screw, press-fit or other type of bone-anchored implant as well as interventions related to these complications.MethodA systematic literature search was conducted in the MEDLINE, Cochrane, EMBASE, CINAHL and Web of Science databases. The included studies reported on device-related complications and interventions occurring in individuals with bone-anchored prostheses. The outcomes evaluated were death, infection, bone/device breakage, implant loosening, soft tissue complications, systemic events, antibiotic and surgical treatment. Subgroup analyses were performed for the following groups: a) implant type (screw, press-fit and other types of implants) and b) level of amputation (transfemoral, transtibial and upper extremity amputation).ResultsOf 309 studies, 12 cohort studies were eligible for inclusion, all of which had methodological shortcomings and 12 studies were excluded due to complete overlap of patient data. Implant infection were rare in certain transfemoral implants (screw: 2–11%, press-fit: 0–3%, Compress: 0%) but common in transtibial implants (29%). The same was observed for implant loosening, in transfemoral (screw: 6%, press-fit: 0–3%, Compress: 0%), transtibial implants (29%) as well as for upper extremity implants (13–23%). Intramedullary device breakage were rare in transfemoral implants (screw: 0%, press-fit: 1%, Compress: unknown) but frequent in individuals with transradial implants (27%) and absent in transtibial implants. Soft tissue infections and complications were common and underreported in most articles.ConclusionsMajor complications (e.g. implant infection, implant loosening and intramedullary device breakage) are rare in transfemoral bone-anchored prosthesis and seem to occur less frequently in individuals with press-fit implants. Minor complications, such as soft tissue infections and complications, are common but are substantially influenced by the learning curve, implant design and surgical technique. Data for patients treated with a transtibial, upper extremity or Compress implant are underreported, precluding definitive conclusions. There is a need for either an international database to report on or a standard core set of complications as well as the need to follow classification systems that result in unequivocal data.研究背景 本研究旨在概述接受螺钉式、压配式或其他类型骨锚式植入物（bone-anchored implant）治疗的上下肢截肢患者所发生的器械相关并发症，以及针对此类并发症的干预措施。 研究方法 本研究在MEDLINE、Cochrane、EMBASE、CINAHL及Web of Science数据库中开展系统性文献检索。纳入的研究需报告骨锚式假体（bone-anchored prosthesis）患者的器械相关并发症及干预措施。本次评估的结局指标包括死亡、感染、骨/器械断裂、植入物松动、软组织并发症、全身不良事件、抗生素治疗及外科手术治疗。随后针对以下组别进行亚组分析：a）植入物类型（螺钉式、压配式及其他类型植入物）；b）截肢平面（经股骨截肢、经胫骨截肢及上肢截肢）。 研究结果 本次共检索到309项研究，其中12项队列研究（cohort study）符合纳入标准，但所有研究均存在方法学缺陷；另有12项研究因患者数据完全重叠被排除。在部分经股骨截肢患者的植入物中，植入物感染发生率较低（螺钉式：2%~11%，压配式：0%~3%，Compress型：0%），但经胫骨截肢患者的感染发生率高达29%。植入物松动的情况与此类似：经股骨截肢患者中（螺钉式：6%，压配式：0%~3%，Compress型：0%）、经胫骨截肢患者中（29%）及上肢截肢患者中（13%~23%）均观察到该并发症。髓内器械断裂在经股骨截肢患者中较为少见（螺钉式：0%，压配式：1%，Compress型：不详），但经桡骨截肢患者的发生率达27%，经胫骨截肢患者则未出现该并发症。软组织感染及并发症在多数文献中较为常见，但报告严重不足。 研究结论 经股骨骨锚式假体的严重并发症（如植入物感染、植入物松动及髓内器械断裂）较为罕见，且压配式植入物患者的并发症发生率似乎更低。轻微并发症（如软组织感染及并发症）较为常见，但受学习曲线、植入物设计及外科手术技术的显著影响。经胫骨截肢、上肢截肢或Compress型植入物治疗患者的相关数据报告不足，无法得出确定性结论。亟需建立用于报告并发症的国际数据库，或制定标准化的并发症核心数据集，同时需遵循可产生明确数据的分类体系。