The effect of using tourniquet and IV tranexamic acid on clinical outcomes and blood loss in unilateral Total Knee Arthroplasty (TKA) surgery: a randomized clinical trial

Investigating the effect of tourniquet and intravenous tranexamic acid on clinical outcomes and bleeding rate in unilateral total knee arthroplasty surgery.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 168 patients. Block method is used for randomization.

A clinical trial with a control group, in the Orthopedic Research Center of Ghaem Mashhad Hospital and double-blind (patient and analyzer)

Patients referring to the knee specialist clinic of Ghaem Hospital in Mashhad city with indications for total knee arthroplasty between 1401 and 1402 were included in the study. Patients are electively subjected to TKA surgery in Ghaem Hospital by a knee surgeon.

Intervention 1: 42 patients undergoing elective total knee arthroplasty (TKA) with indications for the surgery at Qaem Hospital by a knee subspecialist surgeon receive 1000 milligrams of intravenous tranexamic acid (TXA) 30 minutes before incision and an additional 1000 milligrams of intravenous tranexamic acid at the time of wound closure, alongside the use of tourniquet during the operation. Intervention 2: 42 patients undergoing elective total knee arthroplasty (TKA) with indications for the surgery at Qaem Hospital by a knee subspecialist surgeon do not receive TXA injection and tourniquet is used during the operation. Intervention 3: 42 patients undergoing elective total knee arthroplasty (TKA) with indications for the surgery at Qaem Hospital by a knee subspecialist surgeon receive 1000 milligrams of intravenous tranexamic acid (TXA) 30 minutes before incision and an additional 1000 milligrams of intravenous tranexamic acid at the time of wound closure, without the use of tourniquet during the operation.

Bleeding volume, clinical outcomes (pain, joint function)

The random assignment of eligible people to the study is done by a person who is independent from the research team and is not involved in the process of treatment, follow-up of participants, data collection and recording. In order to achieve an equal number of patients in the groups under study and the least amount of difference in the number of people participating in the groups, the allocation of people will be done by block randomization. Due to the fact that 4 groups will be examined and compared in this research, blocks of 4 were used. Based on this and according to the calculated sample size, 42 blocks of four were considered. After the eligible subjects were determined to enter the study and their informed consent in the study was ensured, they were randomly assigned to the groups under study (the group using intravenous TXA, the group using topical TXA in solution and control group) will be allocated. Randomization will be performed using a computerized random assignment sequence. The belonging of people/patients to the groups under study will be blind for the patient, doctor/interventionist, and the person evaluating the results, so that first 42 envelopes containing 4 cards with letter labels indicating the belonging of the patients to the groups under study, will be prepared and given inside opaque envelopes. These envelopes are placed by the secretary of the department, who are not involved in research and recording the outcomes under study. Data before and after the surgical process will be collected and recorded by researchers other than the surgeon.

The belonging of people/patients to the groups under study will be blind to the evaluators of outcomes and the biostatistician who analyzes the data. We will assign unique identifiers or codes to each participant that do not reveal their treatment allocation. These codes will be used in all documentation instead of identifiable information. The actual treatment allocation for each participant will be kept in sealed, opaque envelopes or stored in a secure, restricted-access database. Only specific personnel (e.g., an independent coordinator) will have access to these codes. Outcome evaluators will use forms that contain only the coded identifiers, ensuring no direct indication of treatment allocation is present in the data collection materials. Data collected by evaluators will be stored separately from any information that discloses treatment allocation. This separation will prevent unintentional unblinding during data handling. Data provided to the biostatistician for analysis will only include the coded identifiers and outcome data without any reference to treatment allocation. Results presented to the biostatistician for interpretation should maintain the blinding by using only the coded identifiers without any treatment-related information.

Confidentiality

Clinical trial protocol publication Article publication

Available immediately after results publication

Orthopedics researchers

Formal email with acceptable reason like meta-analysis on data

Dr. Mohammad-Hossein Ebrahimzadeh-Orthopedics Research Center Director

Email to Ebrahimzadehmh@mums.a.ir