Objective The incidence of lower extremity swelling after total knee arthroplasty(TKA)is high,which prevents patients from enhanced recovery.Studies have reported that diosmin,as a blood vessel protector,can effectively reduce venous leakage caused by trauma or surgery,suggesting the potential effect of diosmin in reducing swelling after orthopedic surgery.However,no studies have reported the efficacy of diosmin on lower extremity swelling and postoperative pain after TKA.The objective of this study was to evaluate the efficacy and safety of diosmin in lower extremity swelling,pain and functional outcome after TKA.Methods This prospective randomized controlled multi-center trial recruited patients undergoing TKA from thirteen university-affiliated tertiary hospitals from July 23,2021,through August 23,2022.A total of 351 patients were assessed for eligibility,of whom 18 met the exclusion criteria;and another 3 did not provide consent.The remaining 330 patients were randomized into control group or diosmin group;Patients in the control group did not receive diosmin after surgery.Patients in the diosmin group began to receive diosmin(0.9 g,twice a day)on the day after surgery for 14 consecutive days.Results There was no significant difference in baseline data between the two groups(p > 0.05).The patients in the diosmin group had significantly lower extremity swelling rate in upper pole of patella(day 1 4.90%±3.70% vs.6.85%±5.92%;day 2 6.29%±3.88% vs.8.25%±5.04%;day 3 6.03%±3.75% vs.8.60%±4.85%;day 14 3.46%±3.56% vs.5.44%±4.27%.P < 0.0001),calf(day 1 3.51%±4.14% vs.5.19%±6.57%;day 2 4.47%±3.95%vs.6.36%±5.58%;day 3 4.81%±4.41% vs.6.75%±5.61%;day 14 1.95%±3.05% vs.4.00%±4.31%.P = 0.0001)and thigh(day 1 5.42%±5.41% vs.7.16%±5.31%;day 26.37%±5.56% vs.8.66%±5.68%;day 3 6.51%±5.62% vs.8.61%±5.55%;day 143.00%±5.06% vs.5.28%±6.13%.P = 0.0002).Patients in diosmin group also had significantly lower VAS pain scores during motion(preoperative 4.12±2.31 vs.4.20±2.31;day 1 5.13±1.68 vs.5.50±2.02;day 2 4.28±1.61 vs.4.71±1.79;day 3 3.17±1.35 vs.3.90±1.72;day 14 2.10±1.20 vs.2.73±1.70.P = 0.0043).There were no significant differences in postoperative VAS pain scores at rest,HSS score,ROM,level of serum inflammatory biomarkers,and complication rates between the two groups.However,the postoperative swelling rate of upper pole of patella was significantly negative correlated with ROM(r =-0.404,P < 0.001);the VAS pain scores during motion was significantly negative correlated with ROM(r =-0.393,P < 0.001)and HSS scores(r =-0.328,P < 0.001).Conclusion The administration of diosmin after TKA can reduce lower extremity swelling and postoperative pain during motion.This drug can be considered as a part of enhanced recovery protocol after TKA. |