P. Thornley, A. MacDonald, N. Evaniew, M. Ghert, Division of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada M. Vicente, R. Velez, Orthopaedic Surgery and Traumatology Department, Hospital Universitario Vall d' Hebron, Barcelona, Spain.
Clin Orthop Relat Res. 2019 Apr;477(4):894-902. doi: 10.1097/CORR.0000000000000630.
Excision of bone tumors and endoprosthetic reconstruction allow patients early weightbearing and a potential functional advantage compared with amputation. These reconstructions do not restore the limb to normal status, however, and patients are subject to complications that may result in revision or loss of the limb. Because better understanding of these complications based on current information might help the patient and surgeon in decision-making, we undertook a systematic review of studies published on this topic.
QUESTIONS/PURPOSES: (1) What are the primary modes and proportion of failure of tumor endoprostheses in patients undergoing reconstruction after excision of primary extremity bone sarcomas?
We systematically searched MEDLINE, Embase, and the Cochrane Library for all studies published from April 15, 1998, to April 15, 2018. Three reviewers independently reviewed studies reporting endoprosthetic reconstruction survival and events requiring revision for primary extremity bone tumors treated with endoprosthetic reconstruction for inclusion and performed independent data extraction. We excluded all studies with fewer than five patients, any systematic review/meta-analyses, and any study not reporting on primary extremity bone tumors. All discrepancies were resolved by the study's senior author. Data extracted from included studies were any reoperation event for wound dehiscence, any operative fixation for a pathologic fracture, and any revision of the primary endoprosthesis for implant wear or breakage, deep infection not amenable to prosthesis retention, or for local recurrence. We assessed the overall quality of the evidence with the Methodological Index for Non-Randomized Studies (MINORS) approach with a higher MINORS score representative of a more methodologically rigorous study with a total possible score of 16 points for noncomparative and 24 points for comparative studies. Forty-nine studies met criteria for inclusion from an initial search return of 904 studies, of which no studies were randomized controlled trials. From a total patient population of 2721, there was a mean followup of 93 months (range, 1-516 months) with loss to followup or death occurring in 447 of 2118 (21%) patients with six studies not providing loss to followup data. The mean MINORS score was 14 for prospective studies and 11 for retrospective studies.
Overall, there were 1283 reoperations among the 2721 (47%) patients. Reoperation for mechanical endoprosthetic events (soft tissue dehiscence or periarticular soft tissue instability, aseptic loosening, or implant wear/fracture) occurred in 907 of 2721 (33%) patients. Aseptic loosening occurred at a mean of 75 months (range, 1-376 months) in 212 of 315 patients (67%). Deep infection requiring removal of the initial prosthesis occurred in 247 of 2721 (9%) patients with deep infection occurring at a mean of 24 months (range, 1-372 months) in the 190 infections (77%) with time to infection data available. Local recurrence rates requiring revision or amputation occurred in 129 (5%) of all patients. There was an overall primary endoprosthesis survival rate without any surgical reintervention of 63% among reporting studies at a mean of 79 months followup.
Failures of endoprosthetic reconstructions after extremity tumor surgery are common, most often resulting from implant wear or fracture, aseptic loosening, and infection. Importantly, the aggregated data are the first to attempt to quantify the time to specific complication types within this patient population. Deep infection not amenable to endoprosthesis retention appears to occur approximately 2 years postoperatively in most patients, with aseptic loosening occurring most commonly at 75 months. Although endoprosthetic reconstruction is one of the most common forms of reconstruction after bone tumor resection, the quality of published evidence regarding this procedure is of low quality with high loss to followup and data quality limiting interstudy analysis. The quality of the evidence is low with high loss to followup and inconsistent reporting of times to reintervention events. Although the most common modes of endoprosthetic failure in this population are well known, creation of quality prospective, collaborative databases would assist in clarifying and informing important elements of the followup process for these patients.
Level IV, therapeutic study.
与截肢相比，切除骨肿瘤和进行内假体重建可使患者早期负重并具有潜在的功能优势。然而，这些重建并不能使肢体恢复正常状态，患者可能会出现并发症，从而需要进行翻修或肢体丧失。由于更好地了解这些并发症可能有助于患者和外科医生做出决策，因此我们对发表在这一主题上的研究进行了系统综述。
问题/目的：（1）切除原发性肢体骨肉瘤后进行重建的患者中，肿瘤内假体的主要失效模式和比例是什么？
我们系统地检索了 MEDLINE、Embase 和 Cochrane 图书馆，以获取从 1998 年 4 月 15 日至 2018 年 4 月 15 日发表的所有研究。三名审查员独立审查了报告内假体重建生存和需要翻修的事件的研究，以纳入原发性肢体骨肿瘤的内假体重建治疗，并进行了独立的数据提取。我们排除了病例数少于 5 例、任何系统评价/荟萃分析以及未报告原发性肢体骨肿瘤的任何研究。所有差异均由研究的资深作者解决。从纳入研究中提取的数据包括伤口裂开的任何再手术事件、任何病理性骨折的手术固定以及任何用于假体磨损或断裂、深部感染不可保留假体或局部复发的主要内假体的任何翻修。我们使用非随机研究方法学指数（MINORS）方法评估整体证据质量，较高的 MINORS 分数代表更严格的方法学研究，非比较性研究的总分为 16 分，比较性研究的总分为 24 分。从最初的搜索结果中，有 49 项研究符合纳入标准，其中没有随机对照试验。在总共 2721 例患者中，平均随访 93 个月（范围 1-516 个月），2118 例中有 447 例（21%）患者失访或死亡，6 项研究未提供失访数据。前瞻性研究的平均 MINORS 得分为 14，回顾性研究的平均 MINORS 得分为 11。
总体而言，2721 例患者中有 1283 例进行了再手术。2721 例患者中有 907 例（33%）发生机械内假体事件（软组织裂开或关节周围软组织不稳定、无菌性松动或假体磨损/断裂）。212 例 315 例患者（67%）中出现无菌性松动，平均时间为 75 个月（范围 1-376 个月）。需要取出初始假体的深部感染发生在 2721 例患者中的 247 例（9%），190 例（77%）深部感染中有 127 例（77%）深部感染时间数据可用，深部感染平均发生在 24 个月（范围 1-372 个月）。需要翻修或截肢的局部复发率在所有患者中为 5%。在报告研究中，平均随访 79 个月，无任何手术再干预的主要内假体总体生存率为 63%。
肢体肿瘤手术后内假体重建的失败很常见，最常见的原因是假体磨损或断裂、无菌性松动和感染。重要的是，汇总数据首次尝试在该患者人群中量化特定并发症类型的时间。在大多数患者中，深部感染不可保留假体的情况大约在术后 2 年内发生，无菌性松动最常见的发生时间是 75 个月。尽管内假体重建是骨肿瘤切除后最常见的重建形式之一，但关于该手术的已发表证据质量较低，失访率和数据质量较高，限制了研究间的分析。由于失访率较高且报告的干预事件时间不一致，证据质量较低。尽管该人群中内假体失效的最常见模式是众所周知的，但创建高质量的前瞻性、协作数据库将有助于阐明和告知这些患者的随访过程中的重要内容。
IV 级，治疗性研究。
