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使用 Depuy Synthes 转子间固定钉或转子间固定钉加强型治疗髋部骨折固定后的翻修风险:7979 例患者的队列研究。

Risk of Revision After Hip Fracture Fixation Using DePuy Synthes Trochanteric Fixation Nail or Trochanteric Fixation Nail Advanced: A Cohort Study of 7,979 Patients.

机构信息

Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, California.

Surgical Outcomes and Analysis, Kaiser Permanente, San Diego, California.

出版信息

J Bone Joint Surg Am. 2022 Jun 15;104(12):1090-1097. doi: 10.2106/JBJS.21.01029. Epub 2022 Mar 25.

Abstract

BACKGROUND

Prior reports of the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) revealed a potential mode of fatigue failure at the proximal screw aperture following fixation of extracapsular hip fractures. We sought to compare the revision risk between the TFNA and its prior-generation forebear, the Trochanteric Fixation Nail (TFN).

METHODS

A retrospective cohort study was performed using data from a U.S. integrated health-care system's hip fracture registry. The study sample comprised patients who underwent cephalomedullary nail fixation for hip fracture with a TFN (n = 4,007) or TFNA (n = 3,972) from 2014 to 2019. We evaluated the charts and radiographs for patients who underwent any revision. Multivariable Cox regression was used to evaluate the risk of revision related to the index fracture.

RESULTS

At the 3-year follow-up, the cumulative probability of revision related to the index fracture was 1.8% for the TFN and 1.9% for the TFNA. After adjustment for covariates, no difference was observed in revision risk (hazard ratio [HR], 1.18 [95% confidence interval (CI), 0.80 to 1.75]; p = 0.40) for the TFNA compared with the TFN. The TFNA was associated with a higher risk of revision for nonunion than the TFN (HR, 1.86 [95% CI, 1.11 to 3.12]; p = 0.018). At the 3-year follow-up, implant breakage was 0.06% for the TFN and 0.2% for the TFNA; with regard to aperture failures related to the index fracture, there were 1 failure for the TFN group and 3 failures for the TFNA group.

CONCLUSIONS

In a large cohort from a U.S. hip fracture registry, the TFNA had an overall revision rate that was similar to that of the earlier TFN, with implant breakage being a rare revision reason for both groups. Chart and radiographic review found that the TFNA was associated with a higher risk of revision for nonunion.

LEVEL OF EVIDENCE

Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

摘要

背景

先前关于 DePuy Synthes 转子下固定钉高级版(TFNA)的报告显示,在固定髋关节囊外骨折后,近端螺钉孔处存在潜在的疲劳失效模式。我们旨在比较 TFNA 与其前代产品转子下固定钉(TFN)的翻修风险。

方法

使用来自美国综合医疗保健系统髋关节骨折登记处的数据,进行回顾性队列研究。研究样本包括 2014 年至 2019 年间接受髓内钉固定治疗髋关节骨折的患者,其中 TFN(n=4007)或 TFNA(n=3972)。我们评估了接受任何翻修的患者的图表和 X 光片。多变量 Cox 回归用于评估与指数骨折相关的翻修风险。

结果

在 3 年的随访中,TFN 组和 TFNA 组与指数骨折相关的翻修累积概率分别为 1.8%和 1.9%。调整协变量后,TFNA 组与 TFN 组相比,翻修风险无差异(风险比 [HR],1.18 [95%置信区间 (CI),0.80 至 1.75];p=0.40)。与 TFN 相比,TFNA 与非愈合相关的翻修风险更高(HR,1.86 [95%CI,1.11 至 3.12];p=0.018)。在 3 年的随访中,TFN 组的植入物断裂率为 0.06%,TFNA 组为 0.2%;与指数骨折相关的孔径失效方面,TFN 组有 1 例失效,TFNA 组有 3 例失效。

结论

在美国髋关节骨折登记处的一个大队列中,TFNA 的总体翻修率与早期 TFN 相似,两组中植入物断裂都是罕见的翻修原因。图表和 X 光片复查发现,TFNA 与非愈合相关的翻修风险更高。

证据水平

治疗级别 III。请参阅作者说明,以获取完整的证据级别描述。

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