Department of Orthopaedic Surgery, Shiraniwa Hospital Joint Arthroplasty Center, 6-10-1 Shiraniwadai Ikoma, Nara, 630-0136, Japan.
Department of Orthopaedic Surgery, Osaka Metropolitan University Graduate School of Medicine, 1-4-3 Asahi-machi Abeno-ku, Osaka, 545-8585, Japan.
Arch Orthop Trauma Surg. 2024 Aug;144(8):3797-3805. doi: 10.1007/s00402-024-05475-3. Epub 2024 Aug 6.
Perioperative bleeding in total hip arthroplasty (THA) can lead to various problems, so effective management of blood loss is needed. This prospective, single-blind, randomized controlled trial aimed to compare the efficacy of topical administration of SURGICEL (a hemostatic agent of oxidized regenerated cellulose) powder (SP) and tranexamic acid (TXA) in controlling perioperative bleeding during THA.
In total, 114 patients undergoing THA for osteoarthritis were randomized to either group S (THA with SP) or group T (THA with TXA). Data including patient demographics, laboratory data (C-reactive protein [CRP], hemoglobin, and hematocrit), operative time, and intraoperative blood loss were analyzed. Clinical outcomes were assessed using WOMAC, JOA, FJS scores, and visual analog scale (VAS) scores. Primary outcomes were estimated total and postoperative blood loss, while secondary outcomes included hematological test results and various clinical scores.
57 patients were allocated to each group, with 55 in group S and 56 in group T were finally included in the analysis. There was no significant difference (p = 0.141) in estimated total blood loss between group S (788.2 ± 350.1 ml) and group T (714.1 ± 318.4 ml). Hemoglobin and hematocrit levels and WOMAC, and FJS scores were not significantly different between the two groups at any time point. CRP levels were significantly different on postoperative days 4 and 7, and JOA score was significantly different on preoperative and postoperative period. However, the differences in CRP and JOA score values themselves were relatively small and not clinically different.
Topical administration of SP is as effective as TXA in reducing perioperative bleeding in patients undergoing THA. Additionally, no significant difference was observed in early postoperative clinical outcomes between SP and TXA.
Therapeutic Level I.
The University Hospital Medical Information Network (UMIN) registration number UMIN000047607.
全髋关节置换术（THA）围手术期出血可导致各种问题，因此需要有效控制失血。本前瞻性、单盲、随机对照试验旨在比较局部应用氧化再生纤维素止血剂（SURGICEL，简称 SP）粉末（SP）和氨甲环酸（TXA）在控制 THA 围手术期出血方面的疗效。
共纳入 114 例因骨关节炎行 THA 的患者，随机分为 S 组（THA 加 SP）和 T 组（THA 加 TXA）。分析患者人口统计学资料、实验室数据（C 反应蛋白、血红蛋白、红细胞压积）、手术时间和术中失血量。采用 WOMAC、JOA、FJS 和视觉模拟评分（VAS）评估临床疗效。主要结局为估计总失血量和术后失血量，次要结局包括血液学检查结果和各种临床评分。
每组 57 例患者，其中 S 组 55 例，T 组 56 例最终纳入分析。S 组（788.2±350.1 ml）和 T 组（714.1±318.4 ml）的估计总失血量无显著差异（p=0.141）。两组各时间点血红蛋白和红细胞压积水平及 WOMAC、FJS 评分均无显著差异。术后第 4、7 天 CRP 水平差异有统计学意义，术前和术后 JOA 评分差异有统计学意义。但 CRP 和 JOA 评分值本身的差异较小，无临床意义。
THA 患者局部应用 SP 与 TXA 一样可有效减少围手术期出血。此外，SP 和 TXA 在术后早期临床疗效方面无显著差异。
治疗性 I 级。
日本大学医院医学信息网络（UMIN）注册号 UMIN000047607。
