RESUMEN
Our study sought to investigate the effects of a topical plant-based polysaccharide (PSP) as an adjunctive hemostat to minimize blood loss and improve early clinical outcomes in patients undergoing primary TKA. In this multi-center and randomized proof-of-concept study, 61 patients undergoing TKA were randomly assigned to one of two groups: A) intraoperative utilization of PSP (n=31) or B) no intervention (n=30). The primary outcomes were blood loss and change in hemoglobin, measured preoperatively and 24 hours postoperatively. Other endpoints included postoperative complications, Knee Society Score (KSS), knee range of motion (ROM), and thigh circumference. There was no difference in postoperative change of hemoglobin or calculated blood loss between the PSP and control groups. The PSP group achieved elevated flexion at two weeks (100.1° vs. 86.6°, p<0.05) and better change in KSS from preop to 90 days (29.5 vs. 22.4, p<0.05) than the controls. Some early postoperative outcomes were improved, which suggests a potential benefit of using PSP in primary TKA. However, the clinical significance of these differences warrants further investigation in a larger randomized trial.