The Effect of Intraoperative Administration of Oxidized Regenerated Cellulose on Blood Loss and Thigh Swelling After Total Knee Arthroplasty: A Single-Blind Randomized Controlled Trial.

Abstract

This study aimed to evaluate the effectiveness of oxidized regenerated cellulose (ORC) in reducing perioperative blood loss and postoperative thigh swelling in patients undergoing total knee arthroplasty (TKA). A single-blind randomized controlled trial was conducted, including 100 patients undergoing primary TKA, randomized into the ORC group (n = 50) or placebo group (n = 50). Estimated blood loss (EBL) was calculated using hemoglobin, and thigh swelling was assessed using computed tomography by measuring femoral cross-sectional area and Hounsfield Unit values both preoperatively and one week postoperatively. The secondary outcomes included functional mobility, laboratory data, pain scores, length of hospital stay, and complications. To evaluate the effectiveness of ORC in controlling venous bleeding, EBL was assessed in a subgroup excluding the top 10% of patients who have the highest blood loss, as well as in all patients. In the ORC and placebo groups, the EBL in the subgroup was 690 ± 316 versus 820 ± 285 mL (P = 0.04), the changes in femoral area were 1,606 ± 933 versus 2,178 ± 1,190 mm² (P = 0.01), and the changes in Hounsfield Unit values were 8.8 ± 7.8 versus 13.3 ± 10.3 (P = 0.018), respectively. Multivariate regression analysis identified ORC use as a significant factor for EBL reduction (partial regression coefficient: -127.9, 95% confidence interval: -230.9 to -24.9, P = 0.015). No significant differences were observed in secondary outcomes. No adverse events related to surgeries were reported in this study. Perioperative EBL and postoperative thigh swelling were significantly suppressed in the ORC group compared to the placebo group. In contrast, clinical parameters assessed two weeks postoperatively, including functional mobility, laboratory data, and pain scores, showed no significant differences between the two groups. Ⅰ.