Arthroscopic Rotator Cuff Repair Performed With Intraarticular Tranexamic Acid. Could it Provide Improved Visual Clarity and Less Post-operative Pain? A Prospective, Double Blind, Randomized Study of 63 Patients

Patients and Methods After obtaining institutional review board approval (Istanbul Yeni Yuzyil University, Nr: 13.02.2020/009) together with the registry to ClinicalTrials.gov, patients were prospective enrolled in this observational study, which was designed as double-blind, placebo-controlled and randomized.

Inclusion criteria were defined as: being older than 18 years of age, having an MRI confirmed rotator cuff rupture with a history of failure of conservative treatment of at least 6 months, being willing to participate to the clinical trial.

Patient Selection Exclusion criteria were defined as: patients with a history of coagulopathy, deep venous thrombosis, tendency to thrombotic events, patients under anti-coagulant therapy, patients with inferior vena cava filter, patients with abnormal prothrombin time-activated partial thromboplastin time-bleeding time, patients with a history of cardiac/renal/hepatic disease, patients with a diagnosis of TXA allergy, patients with an acute RCT, having been treated conservatively for less than 6 months, being under the age of 18. Table 1.

As a result of the inclusion/exclusion criteria, 42 patients (14 had acute RCT, 12 were receiving anti-coagulant therapy, 9 had history of cardiac/hepatic/renal disease, 5 had abnormal PT-aPTT value at the time of the diagnosis, 2 had received conservative treatments for less than 6 months for RCR) were excluded from 105 patients, who were eligible and were willing to participate. The remaining 63 patients were enrolled in the study. Table 2 (Flowchart). All patients provided informed consents, so that their pre-operative, intra-operative and post-operative data including imaging studies and arthroscopic images could be used for publication by concealing their identity.

Randomization By using computer based randomization software acquired from random.org, patients were randomized into two groups comprising a TXA group (n=32, 24M, 8F) (TXA Group) and a control group (n=31, 22M,9F) (Control Group), while group information was neither shared with patients nor with the operating surgeon as a result of double-blind nature of the study.