Schatzker type Ⅴ and Ⅵ tibial plateau fractures are usually caused by severe crushing and collapse of the medial and lateral condyles owing to high-energy trauma; however, the internal and external double incision approach, combined with bone grafting and double steel plate fixation, can achieve ideal results14. As there are an abundance of blood vessels around the knee joint, an increase in the incision exposure range and the use of tourniquets can lead to a large amount of blood loss and fibrinolytic response during the perioperative period22. The safety and effectiveness of TXA has been proven in general surgery, joint surgery, and spine surgery. Currently, TXA is administered as intravenous, intramuscular, topical, and oral regimens. As the safety of intramuscular and oral regimens has not been supported by a large number of clinical trials, these methods were excluded from this study. Some scholars have suggested that when TXA is used topically in the joint cavity, joint cavity drainage must not be placed after surgery, to avoid loss of drug efficacy23,24. Therefore, to reduce the bias in the test results, a temporary clamping scheme for the drainage tube for 4 h after operation was used in this study11,25. Given the encouraging results for TXA, the purpose of this study was to confirm which approach was more effective and safe in complex tibial plateau fracture.
In this study, the use of TXA reduced IBL and TPD. Compared with the topical regimen, the IV regimen effectively reduced blood loss by approximately 28 mL (p < 0.001). The topical regimen can effectively reduce TPD by approximately 12 mL, and there was significant difference compares with IV regimen; this conclusion was also reached by Artit et al.26 The IV regimen more effectively reduced the real Hb reduction during the perioperative period, similar to the results of Tzatzairis et al.27
Sehat et al.28 first proposed the concept of HBL and studied the HBL of 63 patients that underwent TKA; they found that HBL accounted for approximately 50% of the TBL. Gao et al.29 found that the TBL of perioperative patients in hip replacement was approximately 859 mL, and the HBL was approximately 525 mL, which accounted for 61% of the TBL. Foss et al.30 studied the hidden blood loss after hip fracture and found that different surgical schemes caused a hidden blood loss of 500 mL to 1473 mL, which was approximately 2 to 3 times greater than the visible blood loss. Therefore, to reduce the blood loss in orthopedic surgery, reduction of the HBL should be the first priority. The main finding of our study was that both intravenous and topical use TXA can effectively reduce TBL during the perioperative period, and that the IV regimen had the strongest effect (approximately 87 mL compared with the topical group, p < 0.001). Similarly, the perioperative HBL was also reduced, but there was no significant difference between the IV regimen and topical regimen.
It has been proposed that the use of tourniquets will lead to excessive fibrinolysis and blood loss within the first 6 h of surgery31. In the current study, the second TXA application in the IV group was before the tourniquet was released and its effect may have be weakened as the fibrinolytic response was already in progress. The topical application of TXA allows it to rapidly reach the active bleeding point and directly interact with the wound, inhibit the fibrinolytic reaction in the blood, promote the formation of fibrin and maintain a stable clot, reduce the leakage of blood to the surface of the damaged tissue, and exert hemostatic effects32. Thus, this explains why there were no great differences between the IV group and topical groups in TBL and HBL.
Thus far, most orthopedic clinical trials have been designed to test the hemostatic effect of TXA instead of safety. For rare complications, such as pulmonary embolism, the current clinical trial sample size cannot reach a definitive conclusion. The results of this study show that patients were safe whether they received IV or topical treatment. The IV regimen appeared to increase the incidence of vascular events and adverse reactions, but with fewer wound complications compared with the control group; however, the difference was not significant. Some studies have confirmed that plasmin not only promotes the activation of monocytes, platelets, and endothelial cells, but also plays an important role in stimulation of the release of inflammatory mediators and the induction of related proinflammatory gene expression. TXA is an inhibitor of plasmin, so ammonia TXA also has potential anti-inflammatory effects33,34. In addition, reducing the perioperative blood transfusion rate may reduce the incidence of wound complications35. We have reduced blood loss by the application of TXA and therefore may also reduce the incidence of wound complications. Hence, we believe that the application of TXA in this study has been shown to be safe.
Another interesting study in this study found that pain in the topical group was significantly reduced in the early and late postoperative periods. In addition, the HSS of this group of patients has a slight advantage in postoperative knee function. This advantage is reflected in the fact that patients can perform a wider range of knee mobility exercises and early ambulation. This can well explain the long-term, higher PCS in the topical group in terms of postoperative quality of life, but this difference is not enough to show statistical significance. However, the application of TXA without improve the psychological impact of patients caused by orthopedic trauma.
There are some limitations to our study. First, the sample size of this study was small and the results are from a single center. A large-scale prospective, randomized case-control study is needed to confirm these results. Second, according to the perioperative rehabilitation guidelines for major orthopedic surgery designated by our institution, all patients received preventive anticoagulation after admission, which may have affected blood loss. Third, blood loss in postoperative wound dressings was not measured.