Efficacy and Safety of Intraosseous Regional Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Randomized Controlled Trial.

IF 4.9 Q2 ORTHOPEDICS

JBJS Open Access Pub Date : 2026-10-15 eCollection Date: 2026-10-01 DOI:10.2106/JBJS.OA.26.00282

Shuaifei Tian, Baochao Ji, Yicheng Li, Xiaogang Zhang, Guoqing Li, Boyong Xu, Li Cao

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Abstract

Background: Tranexamic acid (TXA) reduces perioperative blood loss in total knee arthroplasty (TKA); however, evidence for intraosseous regional administration (IORA) remains limited. We evaluated the efficacy and safety of IORA-TXA versus intravenous TXA (IV-TXA) in TKA.

Methods: In this prospective, randomized, single-center trial, 98 patients undergoing primary TKA were randomized 1:1 to IORA-TXA or IV-TXA (49 per group) at a uniform dose of 20 mg/kg. The primary outcome was calculated perioperative blood loss. Secondary efficacy outcomes included calculated hidden blood loss, postoperative hemoglobin (Hb) levels, and transfusion rate. Safety outcomes included deep vein thrombosis (DVT), muscular calf vein thrombosis, pulmonary embolism (PE), and wound-related complications.

Results: Compared with IV-TXA, IORA-TXA reduced calculated perioperative blood loss (674.8 ± 335.0 vs. 817.5 ± 357.2 mL; mean difference, 142.6 mL; 95% CI, 7.4-277.8; p = 0.038) and calculated hidden blood loss (644.8 ± 335.5 vs. 790.9 ± 339.0 mL; mean difference, 146.1 mL; 95% CI, 10.9-281.3; p = 0.035). Postoperative Hb was similar on POD1 (134.0 ± 9.8 vs. 130.1 ± 11.1 g/L; p = 0.067) but was higher with IORA-TXA on POD2 (119.8 ± 8.3 vs. 113.8 ± 11.5 g/L; mean difference 6.0 g/L; 95% CI 2.0-10.0; p = 0.005) and POD3 (114.8 ± 7.9 vs. 109.8 ± 12.6 g/L; mean difference 5.0 g/L; 95% CI 0.8-9.2; p = 0.020). No patient required blood transfusion. DVT detected by routine postoperative Doppler occurred numerically more often with IORA-TXA than with IV-TXA: 10.2% (95% CI, 3.4%-22.2%) versus 0.0% (95% CI, 0.0%-7.3%); p = 0.056.

Conclusions: IORA-TXA reduced calculated perioperative and hidden blood loss and improved early postoperative Hb preservation compared with IV-TXA. However, DVT incidence was numerically higher with IORA-TXA, indicating a potential thromboembolic safety signal that warrants confirmation in larger, adequately powered trials.

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

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全膝关节置换术中骨内局部与静脉注射氨甲环酸的疗效和安全性：一项随机对照试验。

背景：氨甲环酸（TXA）减少全膝关节置换术（TKA）围手术期出血量；然而，骨内区域管理（IORA）的证据仍然有限。我们评估了IORA-TXA与静脉注射TXA （IV-TXA）在TKA中的疗效和安全性。方法：在这项前瞻性、随机、单中心试验中，98例接受原发性TKA的患者按1:1的比例随机分为IORA-TXA或IV-TXA（每组49例），均匀剂量为20mg /kg。主要观察指标为围手术期出血量。次要疗效指标包括计算的隐性失血量、术后血红蛋白（Hb）水平和输血率。安全性指标包括深静脉血栓形成（DVT）、小腿肌肉静脉血栓形成、肺栓塞（PE）和伤口相关并发症。结果：与IV-TXA相比，IORA-TXA可减少围手术期计算出血量（674.8±335.0 mL比817.5±357.2 mL，平均差值为142.6 mL， 95% CI为7.4 ~ 277.8,p = 0.038）和计算隐性出血量（644.8±335.5 mL比790.9±339.0 mL，平均差值为146.1 mL， 95% CI为10.9 ~ 281.3,p = 0.035）。术后Hb在POD1上相似（134.0±9.8比130.1±11.1 g/L, p = 0.067），但IORA-TXA在POD2上较高（119.8±8.3比113.8±11.5 g/L，平均差6.0 g/L; 95% CI 2.0-10.0, p = 0.005）和POD3（114.8±7.9比109.8±12.6 g/L，平均差5.0 g/L; 95% CI 0.8-9.2, p = 0.020）。没有病人需要输血。术后常规多普勒多普勒检测DVT的发生率IORA-TXA组高于IV-TXA组：10.2% (95% CI, 3.4%-22.2%) vs 0.0% (95% CI, 0.0%-7.3%)；P = 0.056。结论：与IV-TXA相比，IORA-TXA可减少围手术期计算失血量和隐性失血量，改善术后早期Hb保存。然而，IORA-TXA组的DVT发生率在数值上更高，这表明潜在的血栓栓塞安全性信号值得在更大、更有力的试验中得到证实。证据水平：治疗性i级。参见《作者说明》获得证据水平的完整描述。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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