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在原发性恶性骨肿瘤患者中,肿瘤假体在初次翻修后再次发生并发症的可能性有多大,哪些是潜在的风险因素?

What is the Likelihood That Tumor Endoprostheses Will Experience a Second Complication After First Revision in Patients With Primary Malignant Bone Tumors And What Are Potential Risk Factors?

机构信息

C. Theil, J. Röder, G. Gosheger, N. Deventer, R. Dieckmann, D. Schorn, J. Hardes, D. Andreou Department of Orthopedics and Tumor Orthopedics, Muenster University Hospital, Albert-Schweitzer-Campus 1, Muenster, Germany.

出版信息

Clin Orthop Relat Res. 2019 Dec;477(12):2705-2714. doi: 10.1097/CORR.0000000000000955.

Abstract

BACKGROUND

Endoprosthetic reconstruction of massive bone defects has become the reconstruction method of choice after limb-sparing resection of primary malignant tumors of the long bones. Given the improved survival rates of patients with extremity bone sarcomas, an increasing number of patients survive but have prosthetic complications over time. Several studies have reported on the outcome of first endoprosthetic complications. However, no comprehensive data, to our knowledge, are available on the likelihood of an additional complication and the associated risk factors, despite the impact of this issue on the affected patients.

QUESTIONS/PURPOSES: (1) What are the types and timing of complications and the implant survivorship free from revision after the first complication? (2) Does survivorship free from repeat revision for a second complication differ by anatomic sites? (3) Is the type of first complication associated with the risk or the type of a second complication? (4) Are patient-, tumor-, and treatment-related factors associated with a higher likelihood of repeat revision?

METHODS

Between 1993 and 2015, 817 patients underwent megaprosthetic reconstruction after resection of a tumor in the long bones with a single design of a megaprosthetic system. No other prosthetic system was used during the study period. Of those, 75% (616 of 817) had a bone sarcoma. Seventeen patients (3%) had a follow-up of less than 6 months, 4.5% (27 of 599) died with the implant intact before 6 months and 43% (260 of 599 patients) underwent revision. Forty-three percent of patients (260 of 599) experienced a first prosthetic complication during the follow-up period. Ten percent of patients (26 of 260) underwent amputation after the first complication and were excluded from further analysis. Second complications were classified using the classification of Henderson et al. to categorize surgical results. Briefly, this system categorizes complications as wound dehiscence (Type 1); aseptic loosening (Type 2); implant fractures or breakage and periprosthetic fracture (Type 3); infection (Type 4); and tumor progression (Type 5). Implant survival curves were calculated with the Kaplan-Meier method and compared using the log-rank test. Hazard ratios (HR) were estimated with their respective 95% CIs in multivariate Cox regression models.

RESULTS

A second complication occurred in 49% of patients (115 of 234) after a median of 17 months (interquartile range [IQR] 5 to 48) after the surgery for the first complication. The time to complication did not differ between the first (median 16 months; IQR 5 to 57) and second complication (median 17 months; IQR 5 to 48; p = 0.976). The implant survivorship free from revision surgery for a second complication was 69% (95% CI 63 to 76) at 2 years and 46% (95% CI 38 to 53) at 5 years. The most common mode of second complication was infection 39% (45 of 115), followed by structural complications with 35% (40 of 115). Total bone and total knee reconstructions had a reduced survivorship free from revision surgery for a second complication at 5 years (HR 2.072 [95% CI 1.066 to 3.856]; p = 0.031) compared with single joint replacements. With the numbers we had, we could not show a difference between the survivorship free of revision for a second complication based on the type of the first complication (HR 0.74 [95% CI 0.215 to 2.546]; p = 0.535). We did not detect an association between total reconstruction length, patient BMI, and patient age and survivorship free from revision for a second complication. Patients had a higher risk of second complications after postoperative radiotherapy (HR 1.849 [95% CI 1.092 to 3.132]; p = 0.022) but not after preoperative radiotherapy (HR 1.174 [95% CI 0.505 to 2.728]; p = 0.709). Patients with diabetes at the time of initial surgery had a reduced survivorship free from revision for a second complication (HR 4.868 [95% CI 1.497 to 15.823]; p = 0.009).

CONCLUSIONS

Patients who undergo revision to treat a first megaprosthetic complication must be counseled regarding the high risk of future complications. With second complications occurring relatively soon after the first revision, regular orthopaedic follow-up visits are advised. Preoperative rather than postoperative radiotherapy should be performed when possible. Future studies should evaluate the effectiveness of different approaches in treating complications considering implant survivorship free of revision for a second complication.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

在长骨原发性恶性肿瘤保肢切除术后,人工假体重建大块骨缺损已成为首选的重建方法。由于肢体骨肉瘤患者的生存率提高,越来越多的患者能够存活下来,但随着时间的推移,假体并发症也随之增加。已有几项研究报告了初次人工假体并发症的结果。然而,尽管这一问题对受影响的患者有影响,但我们尚不清楚是否存在再次并发症的可能性以及相关的风险因素的综合数据。

问题/目的:(1) 并发症的类型和时间,以及初次并发症后的第一次翻修的假体存活率是多少?(2) 不同解剖部位的再次翻修的无重复并发症存活率是否不同?(3) 初次并发症的类型是否与第二次并发症的风险或类型相关?(4) 患者、肿瘤和治疗相关因素是否与更高的再次翻修可能性相关?

方法

1993 年至 2015 年期间,817 名患者接受了长骨肿瘤切除后采用单一设计的大型假体系统的重建。在研究期间,没有使用其他假体系统。其中 75%(616/817)患有骨肉瘤。17 名患者(3%)随访时间不足 6 个月,4.5%(27/599)在 6 个月前死于植入物完整且未发生并发症,43%(260/599 名患者)接受了翻修。43%的患者(260/599)在随访期间出现了第一次假体并发症。10%的患者(26/260)在第一次并发症后进行了截肢,因此被排除在进一步分析之外。第二次并发症使用 Henderson 等人的分类进行分类,以对手术结果进行分类。简单地说,该系统将并发症分为伤口裂开(类型 1);无菌性松动(类型 2);假体骨折或断裂和假体周围骨折(类型 3);感染(类型 4);和肿瘤进展(类型 5)。使用 Kaplan-Meier 方法计算假体存活率曲线,并使用对数秩检验进行比较。使用多变量 Cox 回归模型估计风险比(HR)及其相应的 95%置信区间(CI)。

结果

在第一次并发症手术后 17 个月(中位数,5-48 个月;IQR)后,有 49%的患者(234 名中的 115 名)发生了第二次并发症。第一次(中位数 16 个月;IQR 5-57)和第二次并发症(中位数 17 个月;IQR 5-48;p=0.976)之间的并发症时间没有差异。第二次并发症后无翻修手术的假体存活率为 2 年时 69%(95%CI 63-76),5 年时 46%(95%CI 38-53)。第二次并发症最常见的模式是感染 39%(45/115),其次是结构并发症 35%(40/115)。与单关节置换相比,全骨和全膝关节置换的 5 年无再次并发症翻修手术的存活率较低(HR 2.072 [95%CI 1.066-3.856];p=0.031)。根据第一次并发症的类型,我们无法显示第二次并发症无翻修手术的存活率之间存在差异(HR 0.74 [95%CI 0.215-2.546];p=0.535)。我们没有发现总重建长度、患者 BMI 和患者年龄与第二次并发症无翻修手术之间存在相关性。术后放疗的患者发生第二次并发症的风险更高(HR 1.849 [95%CI 1.092-3.132];p=0.022),但术前放疗的患者则没有(HR 1.174 [95%CI 0.505-2.728];p=0.709)。初次手术时患有糖尿病的患者第二次并发症无翻修手术的存活率降低(HR 4.868 [95%CI 1.497-15.823];p=0.009)。

结论

接受翻修治疗初次大型假体并发症的患者必须对未来并发症的高风险进行咨询。由于第一次翻修后很快就会发生第二次并发症,因此建议进行定期的矫形随访。如果可能,应进行术前放疗而不是术后放疗。未来的研究应评估考虑第二次并发症无翻修手术的假体存活率的不同方法在治疗并发症方面的有效性。

证据水平

III 级,治疗性研究。

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