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经股骨转子间骨折内固定治疗转移性股骨转子周围疾病的效果是否持久?

Is a Cephalomedullary Nail Durable Treatment for Patients With Metastatic Peritrochanteric Disease?

机构信息

D. H. Chafey, Department of Orthopaedics and Rehabilitation, University of New Mexico School of Medicine, Albuquerque, NM, USA V. O. Lewis, R. L. Satcher, B. S. Moon, P. P. Lin, Department of Orthopaedic Oncology, MD Anderson Cancer Center, Houston, TX, USA.

出版信息

Clin Orthop Relat Res. 2018 Dec;476(12):2392-2401. doi: 10.1097/CORR.0000000000000523.

Abstract

BACKGROUND

Although cephalomedullary nail fixation is often used for metastatic peritrochanteric lesions of the femur, there is concern regarding the durability of the implant in comparison to endoprosthetic reconstruction. Previous studies have reported the proportion of patients who undergo reoperation for loss of stability, but the adequacy of the construct has not been critically evaluated in a competing risk analysis that incorporates death of the patient in the calculation.

QUESTIONS/PURPOSES: (1) What is the cumulative incidence of reoperation of cephalomedullary nails with death as a competing risk for metastatic lesions of the proximal femur? (2) What is the survival of patients with metastases to the proximal femur after cephalomedullary nailing? (3) What clinical factors are associated with implant stability in these patients?

METHODS

Between 1990 and 2009, 11 surgeons at one center treated 217 patients with cephalomedullary nails for metastatic proximal femoral lesions. This represented 40% (217 of 544) of the patients undergoing surgery for metastases in this location during the study period. In general, we used cephalomedullary nails when there was normal bone in the femoral head, no fracture in the neck, and a moderate-sized lesion; we favored bipolar hemiarthroplasty for femoral neck fractures and disease affecting the femoral head; finally, we used proximal femoral endoprosthetic replacement for large lesions with severe bone destruction. A retrospective study was conducted of 199 patients with cephalomedullary nails for peritrochanteric metastases from 1990 to 2009. Pathologic fracture, defined as a breach in cortex with a clear fracture line either with or without displacement, was present in 61 patients. The most common primary cancers were breast (42 of 199 patients [21%]), lung (37 of 199 patients [18%]), and renal cell (34 of 199 patients [17%]). A competing risk analysis was performed to describe the cumulative incidence of implant revision. Patient overall survival was assessed by Kaplan-Meier survivorship. A univariate analysis was performed to determine whether there was an association between revision surgery and various patient factors, including tumor histology, pathologic fracture, cementation, and radiation.

RESULTS

Loss of implant stability necessitating revision surgery occurred in 19 of 199 patients (10%). In a competing risk analysis with death of the patient as the competing event, the cumulative incidence of revision surgery was 5% (95% confidence interval [CI], 3%-9%) at 12 months and 9% (95% CI, 5%-13%) at 5 years. Using Kaplan-Meier analysis, the overall patient survival was 31% (95% CI, 25%-37%) at 12 months and 5% (95% CI, 3%-9%) at 60 months. Patients with lung cancer had the shortest overall survival of 11% (95% CI, 1%-21%) at 12 months, and patients with multiple myeloma had the longest overall survival of 71% (95% CI, 49%-94%) at 12 months (p < 0.001). Duration of patient survival beyond the median 7 months was the only factor associated with a greater likelihood of revision surgery. Factors not associated with revision included tumor histology, pathologic fracture, closed versus open nailing, cementation, gender, age, and postoperative radiation.

CONCLUSIONS

The competing risk analysis demonstrates a relatively low cumulative incidence of reoperation and suggests that cephalomedullary nailing is reasonable for patients with moderate-sized proximal femoral metastasis not affecting the femoral head. For the large majority of patients, the construct achieves the goal of stabilizing the femur for the duration of the patient's life. Longer patient survival was associated with greater risk of revision surgery, but no particular tumor histology was found to have a greater cumulative incidence of reoperation. Future work with a larger number of patients and stricter surgical indications may be needed to corroborate these findings.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

尽管髓内钉固定常用于股骨转移部位的粗隆间病变,但与假体重建相比,人们对植入物的耐久性存在担忧。既往研究报道了因稳定性丧失而再次手术的患者比例,但在包含患者死亡的竞争风险分析中,并未对构建体的充分性进行严格评估。

问题/目的:(1)对于股骨近端转移瘤患者,将髓内钉的再手术率与死亡作为竞争风险,其累积发生率是多少?(2)股骨近端采用髓内钉治疗转移瘤的患者的存活率是多少?(3)哪些临床因素与这些患者的植入物稳定性相关?

方法

1990 年至 2009 年,1 家中心的 11 位外科医生对 217 例股骨近端转移瘤患者采用髓内钉治疗。这代表了研究期间该部位转移瘤手术患者的 40%(217/544)。一般来说,当股骨头有正常骨、股骨颈无骨折且病变中等大小时,我们会使用髓内钉;当股骨颈骨折且病变累及股骨头时,我们更倾向于使用双极半髋关节置换术;最后,当病变较大且伴有严重骨破坏时,我们会使用近端股骨假体置换术。对 1990 年至 2009 年采用髓内钉治疗股骨粗隆间转移瘤的 199 例患者进行了回顾性研究。病理性骨折定义为皮质破裂,伴有或不伴有移位的明确骨折线。61 例患者存在病理性骨折。最常见的原发性癌症为乳腺癌(42/199 例患者[21%])、肺癌(37/199 例患者[18%])和肾细胞癌(34/199 例患者[17%])。采用竞争风险分析描述了植入物翻修的累积发生率。通过 Kaplan-Meier 生存分析评估患者的总体生存率。采用单变量分析确定翻修手术与患者的各种因素(包括肿瘤组织学、病理性骨折、骨水泥固定和放疗)之间是否存在关联。

结果

199 例患者中有 19 例(10%)发生植入物失稳,需要进行翻修手术。在以患者死亡为竞争事件的竞争风险分析中,12 个月时的翻修手术累积发生率为 5%(95%置信区间,3%-9%),5 年时为 9%(95%置信区间,5%-13%)。采用 Kaplan-Meier 分析,患者的总体生存率为 12 个月时 31%(95%置信区间,25%-37%),60 个月时 5%(95%置信区间,3%-9%)。肺癌患者的总体生存率最短,为 12 个月时 11%(95%置信区间,1%-21%),多发性骨髓瘤患者的总体生存率最长,为 12 个月时 71%(95%置信区间,49%-94%)(p < 0.001)。患者的生存时间超过中位数 7 个月是与翻修手术可能性更大相关的唯一因素。与翻修无关的因素包括肿瘤组织学、病理性骨折、闭合与开放髓内钉、骨水泥固定、性别、年龄和术后放疗。

结论

竞争风险分析显示,再次手术的累积发生率相对较低,表明髓内钉对于不影响股骨头的中等大小股骨近端转移瘤患者是合理的。对于绝大多数患者来说,该构建体能够实现稳定股骨的目标,直至患者死亡。患者生存时间越长,翻修手术的风险越大,但没有发现特定的肿瘤组织学与更高的累积再手术率相关。可能需要进一步开展具有更大患者数量和更严格手术适应证的研究,以验证这些发现。

证据等级

III 级,治疗性研究。

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