Patients who undergo total ankle replacement surgery can sometimes develop problems with wound healing after their operation. These complications may include delayed healing, wound opening, or infection, which can lead to additional clinic visits, further surgery, and longer recovery times.
Tranexamic acid (TXA) is a medication that has been used safely for many years in many types of surgery to reduce bleeding. Some studies suggest that it may also improve wound healing after foot and ankle surgery by reducing bleeding and swelling around the surgical site. However, there is not enough high-quality evidence to know whether TXA truly improves outcomes for patients undergoing total ankle replacement.
This study is a pilot clinical trial designed to determine whether a larger study can be successfully carried out. Approximately 40 patients undergoing total ankle replacement surgery at The Ottawa Hospital will be randomly assigned to receive either TXA or a placebo (salt water solution). Neither the patients nor their health care team will know which treatment was given until the study is complete. All patients will receive standard surgical care and follow-up regardless of which group they are assigned to. Researchers will then collect information about wound healing, complications, additional surgeries, and infections at routine follow-up visits for up to six months after surgery.
The outcomes will be compared between patients in each group. The results of this pilot study will help determine whether a larger clinical trial is feasible and may provide early information about whether TXA could improve recovery after total ankle replacement surgery. Ultimately, this research aims to improve patient outcomes and reduce complications following ankle replacement surgery.
Patient undergoing either primary or revision ankle replacement surgery
Patient is considered to benefit from surgical management at the treating surgeon's discretion
The patient is willing and able to provide written informed consent
The patient is willing and able to comply with post-operative rehabilitation protocols and all follow-up visits
Pregnant or breastfeeding patient
Uncontrolled diabetes (HgbA1C > 8)
Known allergy or contraindication for tranexamic acid use including: presence of coronary stents, cerebrovascular event in the last six months, known thromboembolic disorder, hepatic dysfunction, impaired renal clearance, medications with known drug interactions***
Lateral-based ankle replacement system
Parallel
Transexamic acid
DrugPatients 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.
Normal Saline (0.9% NaCl)
DrugPatients 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.
Recruitment rate
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months
Treatment Fidelity
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.
Retention Rate
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.
Consent Rate
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.
Trial Implementation Barriers
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.
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