Haemostatic effect of Oxidised Regenerated Cellulose versus Intravenous Tranexamic Acid in Total Knee Arthroplasty: A Randomised Control Trial

Total knee arthroplasty (TKA) stands as a time-tested intervention for addressing end-stage knee degenerative arthritis with excellent results. Despite its generally acknowledged safety, TKA procedures may lead to considerable perioperative blood loss, reaching up to 1500 mL. This substantial blood loss can necessitate blood transfusions, posing risks of periprosthetic infection and adverse hypersensitivity reactions, susceptibility to blood-borne diseases and immune-related disorders, while also potentially leading to various complications including lung injury, renal failure, and coagulation abnormalities. Consequently, minimizing blood loss following TKA emerges as a pivotal factor in enhancing patients’ postoperative recovery and rehabilitation. Moreover, excessive blood loss among TKA patients escalates both the economic strain on healthcare systems and individuals due to increased transfusion needs and prolonged hospital stays. Oxidized regenerated cellulose (ORC) represents a form of biodegradable topical haemostatic material. Yackel et al. first synthesized and investigated oxidized cellulose in 1942, revealing its plant-derived nature and highlighting its safety, ease of application, and clinical efficacy. Presently, ORC finds widespread utilization as an absorbable haemostatic agent across various medical domains such as neurosurgery, thoracic surgery, general surgery, urology, and gynaecology. Even though the adoption of ORC in orthopaedic contexts and arthroplasty remains relatively limited, previous studies have demonstrated that ORC can effectively reduce the total blood loss and hidden blood loss of patients after total knee arthroplasty under the premise of ensuring safety, and avoid transfusion due to excessive blood loss. Tranexamic acid (TXA), functioning as an antifibrinolytic agent, enjoys broad acknowledgment for its safety and efficacy in mitigating blood loss during TKA procedures. Although contemporary guidelines advocate for the standardized incorporation of TXA in TKA protocols, debates persist regarding the optimal dosage and administration route. Network meta-analysis have shown low-dose intravenous, high-dose intravenous, low-dose topical, high-dose topical and oral TXA as well as combinations of intravenous/topical and intravenous/ oral TXA to reduce blood loss and risk of transfusion during the perioperative episode of a TKA and no clear superior method or combination of methods. However, Contraindications that limit the use of TXA include a history of a thromboembolic or ischemic event such as PE, DVT, ischemic cerebrovascular accident, acute myocardial infarction, or ischemic retinopathy.  Moreover, within the existing literature, while numerous investigators have affirmed the efficacy of TXA in diminishing visible blood loss, there remains contention regarding its impact on hidden blood loss. Certain studies have indicated that TXA administration in knee replacement cases leads to a reduction in external blood loss while failing to affect hidden blood loss. Our study aims to compare the clinical efficacy with regards to total and hidden blood loss reduction after total knee arthroplasty as well as safety between ORC and tranexamic acid, aiming to provide a safer and more effective haemostatic solution for patients with or without contraindications to tranexamic acid usage

Null Hypothesis: Haemostatic effect of Oxidised Regenerated Cellulose is inferior to IV Tranexamic acid when used in TKA by a clinically relevant amount