The Effect of Tranexamic Acid Vs Torniquet on Visual Clarity in Knee Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction

Study Design This study is a randomized prospective controlled trial. All patients with complete ACL from the three orthopedic teams at UHWI will be screened for inclusion criteria ACL tears requiring reconstruction for the first time. Patients will be approached by the Research Assistant and once agreement to participate has been obtained, will be informed of the study and given an informed consent (Appendix A). All consents will be done by the Research Assistant not involved in patient care.

The recruitment will take place in a discrete room within Orthopedics outpatient department where the patient will be informed of the details of the study and the right to participate or refuse. It will be reinforced that refusal to participate will not void the standard of care offered to patient. The study will be conducted over a two (2) year period in the Main Operating Theatre. The information gathered will be stored on a password encrypted computer stored in the Principal Investigator's office which can be accessed only by the Investigator or Principal Investigator. Data will be analyzed using Statistical Package for the Social Sciences (SPSS)

Meta analysis and subsequent prospective randomized studies have estimated that tourniquet use would be expected to be associated with poor visibility in only 0-3% of arthroscopic knee procedures. Excellent visibility would be expected in 90% to 97% of cases while no tourniquet would produce good or excellent visibility in approximately 80% of procedures (36, 37). A construct of 2 pairs of simulation populations with a) 97% scores of 1 (excellent visibility) in both the control and experimental groups and b) 97% scores of 1 in the control group and 80% scores of 1 in the experimental group. When the two populations with no stochastic difference were sampled, a sample size of 30 per arm was adequate to produce a BF_10 greater than 3 (i.e. support for the alternate hypothesis) for 90% of samples. Conversely, for two populations where there is a stochastic superiority of the control to the experimental, a sample size of 20 per arm produces a BF_10 less than 1/3 (i.e. support for the null hypothesis) for 90% of samples. We will be analyzing on an incremental basis and stop patient accrual when we either achieve a BF_10 greater than 10 or less than 1/10 (strong evidence for the alternate or null hypothesis) (35) or we achieve a cumulative sample size of 60 patients.

Research Procedures/Protocols - Data Collection/Research Intervention Procedures

Patients will be randomized with the help of an online randomization tool Randomization tool @ https://ctrandomization.cancer.gov/tool/ (National Cancer Institute Clinical trial randomization tool) being placed in one of two arms: TXA alone and Torniquet alone.