Krauss Eugene S, Segal Ayal, Simonson Barry G, Dengler Nancy, Cronin MaryAnne
Department of Orthopaedic Surgery, Syosset Hospital, Northwell Health, Syosset, NY, USA.
Zucker School of Medicine, Hofstra/Northwell, Hempstead, NY, USA.
Arthroplast Today. 2024 Sep 23;29:101509. doi: 10.1016/j.artd.2024.101509. eCollection 2024 Oct.
This was a noninferiority trial to evaluate blood loss during total knee arthroplasty (TKA) when using the unipolar electrocautery system compared to the saline coupled bipolar sealer system in primary TKA.
One hundred sixty-four patients were randomly assigned by a 1:1 ratio to either the unipolar electrocautery system (N = 82) or bipolar sealer system (N = 82). Inclusion criteria included patients scheduled for primary unilateral TKA, preoperative hemoglobin ≥11 mg/dL, preoperative platelet count ≥150,000, age >18 years, and patient willing to complete all study-related procedures. The primary efficacy outcome was estimated blood loss on morning of postoperative day. Secondary efficacy outcomes were comparison between the preoperative hemoglobin and postoperative day 1 hemoglobin, and allogeneic blood transfusions. Additionally, the study collected objective and functional outcomes using the postoperative 2011 Knee Society Score.
The unipolar electrocautery system was not found to be less efficacious than the bipolar sealer system. Mean blood loss for the unipolar electrocautery system was 1062.0 cubic centimeters (cc) (95% confidence limit for the mean: 985.2, 1138.7), and for the bipolar sealer system was 929.4 cc (95% confidence limit for the mean: 841.9, 1016.8). The mean difference in blood loss was 132.6 cc, below the margin of inferiority set at 200 cc. Additionally, there was no difference in patient outcomes as measured by the Knee Society Score.
The safety, efficacy, and outcomes profile of the unipolar electrocautery system compared to the bipolar sealer system were similar. Use of the bipolar sealer system significantly increases surgical cost without any added benefits.
这是一项非劣效性试验，旨在评估在初次全膝关节置换术（TKA）中使用单极电灼系统与盐水耦合双极密封系统时的失血量。
164例患者按1:1比例随机分配至单极电灼系统组（N = 82）或双极密封系统组（N = 82）。纳入标准包括计划进行初次单侧TKA的患者、术前血红蛋白≥11 mg/dL、术前血小板计数≥150,000、年龄>18岁以及愿意完成所有与研究相关程序的患者。主要疗效指标为术后第一天早晨的估计失血量。次要疗效指标为术前血红蛋白与术后第1天血红蛋白的比较以及异体输血情况。此外，该研究使用2011年膝关节协会评分收集客观和功能结果。
未发现单极电灼系统的疗效低于双极密封系统。单极电灼系统的平均失血量为1062.0立方厘米（cc）（均值的95%置信区间：985.2，1138.7），双极密封系统的平均失血量为929.4 cc（均值的95%置信区间：841.9，1016.8）。失血量的平均差异为132.6 cc，低于设定的非劣效性界限200 cc。此外，根据膝关节协会评分衡量的患者结果没有差异。
与双极密封系统相比，单极电灼系统的安全性、疗效和结果概况相似。使用双极密封系统会显著增加手术成本且无任何额外益处。
