Topical co-delivery of platelet rich fibrin and tranexamic acid does not decrease blood loss in primary total knee arthroplasty compared to the standard of care: a prospective, randomized, controlled trial

Abstract

Purpose The purpose of this study was to evaluate the efcacy of intra-operative co-administration of tranexamic acid (TA) and platelet rich fbrin (PRF) using a proprietary co-delivery system on the amount of blood loss, early functional outcomes and wound complications after primary total knee arthroplasty (TKA). The intervention was compared to the standard of care (combined intravenous & topical TA) in a prospective, randomized, blinded setting. Methods 80 patients undergoing primary cemented TKA without tourniquet were prospectively randomized into control (combined intravenous and topical TA) and PRF (intra-venous TA and co-delivery of topical PRF and TA) groups after informed consent. Total blood loss, drainage blood loss, knee range of motion, VAS pain scores, length of stay and wound complications were analysed. Data collection was performed in a double blind manner on days 1, 3 and 21. Results There was no statistically signifcant diference in drainage blood loss (550 ml vs. 525 ml, p=0.643), calculated total blood loss on day 1 (401 ml vs. 407 ml, p=0.722), day 3 (467 ml vs 471 ml, p=0.471) and day 21 (265 ml vs. 219 ml, p=0.082) between the PRF and control groups respectively. The PRF group had a small but statistically signifcant increase in median knee extension in the early post-operative period, however this diference evened out at 3 weeks. No signifcant diference could be demonstrated between the PRF and control groups in length of stay, VAS pain scores, narcotic usage, wound complications and knee fexion at all time points. Conclusions The topical co-delivery of PRF and TA does not signifcantly decrease blood loss in primary TKA compared to the standard of care. Slightly better active knee extension in the frst 3 postoperative days can be achieved, however this beneft is not clinically relevant. Level of evidence I, Therapeutic study.