J. V. Palanisamy, K. H. Moon, D. H. Kim, Department of Orthopedic Surgery, Seoul National University Bundang Hospital, Seoul, Republic of Korea S. Das, T. K. Kim, Department of Orthopedic Surgery, TK Orthopedic Surgery, Seongnam, Republic of Korea.
Clin Orthop Relat Res. 2018 Nov;476(11):2148-2154. doi: 10.1097/CORR.0000000000000378.
Medial opening wedge high tibial osteotomy (HTO) entails extensive soft tissue release that may lead to substantial perioperative bleeding. Although tranexamic acid (TXA) is a well-established blood-conserving agent in total joint arthroplasty, its potential to reduce blood loss in patients undergoing HTO has not been studied extensively.
QUESTIONS/PURPOSES: (1) Does TXA reduce total estimated blood loss in HTO? (2) Does TXA use in HTO affect in-hospital endpoints as measured by visual analog scale (VAS) pain scores at rest the day after surgery, wound complications in the immediate postoperative period, blood transfusions, or symptomatic deep vein thrombosis?
Between January 2015 and May 2017, a single surgeon performed 156 HTOs, all of which were done using the medial opening wedge technique. We began using intravenous TXA for all HTOs in June 2016. This left us with 89 patients who were treated during a time when no TXA was used and 67 patients who were treated when all patients received TXA. Two patients in the control group had simultaneous TKA in the contralateral leg and one patient in each group had missing data so these patients were excluded, leaving 86 (97%) patients in the control group and 66 (98.5%) in the TXA group available for analysis in this retrospective study. There were no demographic differences between the groups in terms of age, sex, body mass index, and baseline hemoglobin values. Total estimated blood loss was the primary outcome variable, which was calculated using total blood volume and decrease in hemoglobin values. Secondary outcome variables included pain VAS at rest the day after surgery, wound complications in the immediate postoperative period, allogeneic blood transfusions, and occurrence of symptomatic thromboembolic manifestations. The decision on when to transfuse was based on predetermined criteria. An orthopaedic surgeon not involved in patient care collected the patient data from electronic medical records and did chart review.
The TXA group had less total blood loss (372 ± 36 mL versus 635 ± 53 mL, mean difference 263 mL [95% confidence interval, 248-278]; p < 0.001). Between groups, differences in VAS pain scores at rest the day after surgery favored the TXA group but were small and unlikely to be clinically important. There were two wound complications in the control group (one hematoma and one superficial wound infection) and none in the TXA group. No patients in either group received a blood transfusion, and no symptomatic thromboembolic events were detected in either group.
This study demonstrates that the systemic administration of TXA reduces postoperative blood loss in medial opening wedge HTO; however, insofar as no transfusions were administered to patients even before the routine use of TXA in this series, and no clinically important differences in pain scores were identified, the clinical benefit of routine use of TXA in patients undergoing HTO is uncertain. Our study was too small to make safety-related claims on rare endpoints such as wound complications or thromboembolic events. Larger, and preferably randomized, trials are needed to help define whether it is important to use TXA in this setting. Our data can help inform sample size calculations for such studies.
Level III, therapeutic study.
内侧开放楔形胫骨高位截骨术（HTO）需要广泛的软组织松解，这可能导致大量围手术期出血。尽管氨甲环酸（TXA）在全关节置换术中是一种公认的血液保存剂，但它在 HTO 患者中减少失血的潜力尚未得到广泛研究。
问题/目的：（1）TXA 是否减少 HTO 中的总估计失血量？（2）TXA 在 HTO 中的使用是否会影响术后疼痛视觉模拟评分（VAS）在术后第 1 天静息时、术后即刻伤口并发症、输血或有症状的深静脉血栓形成等院内终点？
2015 年 1 月至 2017 年 5 月，一位外科医生进行了 156 例 HTO，均采用内侧开放楔形技术。我们于 2016 年 6 月开始对所有 HTO 使用静脉内 TXA。这使得我们有 89 名患者在未使用 TXA 时接受治疗，67 名患者在所有患者接受 TXA 时接受治疗。对照组中有 2 例患者在对侧腿同时进行了全膝关节置换术，每组中有 1 例患者数据缺失，因此这些患者被排除在外，因此在这项回顾性研究中，对照组有 86 名（97%）患者和 TXA 组有 66 名（98.5%）患者可用于分析。两组在年龄、性别、体重指数和基线血红蛋白值方面无人口统计学差异。总估计失血量是主要观察变量，通过总血容量和血红蛋白值下降来计算。次要观察变量包括术后第 1 天静息时的疼痛 VAS、术后即刻伤口并发症、异体输血和有症状的血栓栓塞表现。输血的决定基于预定的标准。一位不参与患者护理的矫形外科医生从电子病历中收集患者数据并进行病历回顾。
TXA 组总失血量较少（372 ± 36 mL 比 635 ± 53 mL，平均差异 263 mL[95%置信区间，248-278]；p < 0.001）。两组术后第 1 天静息时 VAS 疼痛评分的差异有利于 TXA 组，但差异较小，不太可能具有临床重要性。对照组有 2 例伤口并发症（1 例血肿和 1 例浅表伤口感染），TXA 组无伤口并发症。两组均未输血，也未发现有症状的血栓栓塞事件。
本研究表明，系统给予 TXA 可减少内侧开放楔形 HTO 术后的失血；然而，鉴于在本系列研究中常规使用 TXA 之前，甚至没有给患者输血，而且疼痛评分也没有明显的临床差异，因此在 HTO 患者中常规使用 TXA 的临床获益尚不确定。我们的研究规模太小，无法对伤口并发症或血栓栓塞等罕见终点进行安全性相关的声明。需要更大的、最好是随机的试验来帮助确定在这种情况下使用 TXA 是否重要。我们的数据可以帮助确定此类研究的样本量计算。
III 级，治疗性研究。
