The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. (TXA in TAR)

Patients will receive 1.5g of TXA in 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation. A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge after implant placement and prior to closure. This will be left in place for five minutes.

Patients in the intervention group will receive 1.5g of TXA in 100ml normal saline (NS) solution. A second dose of 3g in 100ml NS of tranexamic acid will be given topically through a soaked sponge.

Patients will receive either 100ml normal saline (NS) solution intravenously within our hour prior to skin incision, and prior to tourniquet inflation. Then, a 100ml normal saline solution will be given topically through a soaked sponge after implant placement and prior to closure. This will be left in place for five minutes.

Patients in the placebo group will receive 100ml normal saline (NS) solution intravenously. A second dose of 100ml normal saline will be given topically through a soaked sponge.

The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months.

A secondary feasibility outcome of the pilot trial is treatment fidelity, defined by adherence to study drug assignment and pilot trial protocol over 6 months of study involvement.

A secondary feasibility outcome of the pilot trial is retention rate, defined by participant completion of the pilot trial protocol over 6 months follow-up.

A secondary feasibility outcomes of the pilot trial include is consent rates for eligible participants who are approached over 12 months, including reasons for non-consent.

A secondary feasibility outcome of the pilot trial is trial implementation barriers. These include data capture and study management barriers, study team infrastructure challenges, participant- and site-level challenges, intervention-related challenges, and longitudinal study design challenges. Outcomes categorized as not requiring major protocol changes, minor amendable protocol changes, or significant design/safety concerns.

A secondary clinical outcome measure, to be studied further in the definitive trial, is wound complications. Wounds will be assessed at 2 weeks, 6 weeks, 3 months, and 6 months. Each wound will be given a grade from zero to seven, as defined by the Foot and Ankle Postoperative Wound Classification scheme by Schipper et al. Zero indicates no complication and seven indicates the most sever complications. Wounds will be graded by two different assessors.

A secondary clinical outcome measure, to be studied further in the definitive trial, is re-operation rate. Relevant re-operations included will be for any subsequent surgery related to the TAR procedure, including wound-related debridement, prosthetic revision surgery (including any component revision) and others. Re-operations within 6 months of primary surgery will be included.

A secondary clinical outcome measure, to be studied further in the definitive trial, is prosthetic joint infections. Prosthetic joint infection will be defined as any infection that is confirmed by culture swab and treated with antibiotics. Infections will be subdivided into superficial infections (swab positive superficial to fascia) and deep infections (swab positive in direct contact with the prosthesis). Infections will be included up to 6 months from primary surgery.

VA secondary clinical outcome measure, to be studied further in the definitive trial, is venous thromboembolism (VTE) events. VTE events will be captured based on confirmation on investigation with either lower extremity doppler ultrasound for lower extremity deep vein thrombosis, or chest helical CT or ventilation/perfusion scan for investigation for pulmonary embolism. Events will be included within 6 months of primary surgery.