Ankle ArthritisPhase 2TXA in TARNCT07828262
The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement.
A Phase 2 study testing Transexamic acid and Normal Saline (0.9% NaCl) in people with Ankle Arthritis and Wound Complication, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Arthritis, Wound Complication
- What is being tested?
- Transexamic acid and Normal Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patient receiving anticoagulation therapy
- Investigator concerns about study compliance
Show all 9Show fewer
- Medically unfit for surgery or anesthetic
- Acquired color vision problems that are not genetics
- There are potential drug-drug interactions leading to myocardial infarction after coadministration of tranexamic acid with hormonal contraceptives, hydrochlorothiazide, desmopressin, sulbactam-ampicillin, carbazochrome, ranitidine, or nitroglycerin. Therefore, patients on these medications will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Clinical Research Coordinator, BSc contact
Canada1 site
The Ottawa Hospital Civic Campus
Ottawa, Ontario, K1Y 4E9
Clinical Research Coordinator, 6137378899 ext. 19217, hghaziasgar@ohri.ca
About this study
Official title: The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled pilot trial designed to determine the feasibility of conducting a definitive multicentre randomized controlled trial evaluating intravenous and topical tranexamic acid (TXA) for reducing postoperative wound complications following primary total ankle replacement (TAR). The trial will also collect preliminary safety and clinical outcome data to estimate the potential effect of TXA on postoperative wound complications.
Patients with ankle arthritis scheduled to undergo primary TAR will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized in a 1:1 ratio to receive either intravenous and topical TXA or placebo (normal saline) administered according to the study protocol. Participants, treating surgeons, clinical staff, outcome assessors, and investigators will remain blinded to treatment allocation throughout the study.
All participants will undergo standard perioperative management and postoperative care as determined by their treating surgeon. Follow-up assessments will occur according to the routine postoperative schedule through six months after surgery. Data collected will include participant demographics, medical history, operative characteristics, study drug compliance, adverse events, and clinical outcomes.
The primary objective of this pilot trial is to determine the feasibility of conducting a definitive multicentre randomized controlled trial. Feasibility outcomes include participant recruitment, protocol adherence, treatment compliance, retention, completeness of follow-up, and completeness of outcome data collection.
Secondary objectives are to obtain preliminary estimates of the effect of intravenous TXA on postoperative wound complications and other clinically relevant outcomes, including surgical site infection, reoperation, blood transfusion, thromboembolic events, hospital readmission, and patient-reported outcome measures. Safety outcomes, including adverse events and serious adverse events, will also be monitored throughout the study.
The results of this pilot study will inform the design and implementation of a future adequately powered multicentre randomized controlled trial evaluating the effectiveness of intravenous TXA in improving outcomes following total ankle replacement.
- Conditions
- Ankle Arthritis, Wound Complication
- Being tested
- Transexamic acid, Normal Saline (0.9% NaCl)
- Keywords
- ankle replacement, wound infection, total ankle arthroplasty, tranexamic acid
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transexamic acidDrug
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.
Normal Saline (0.9% NaCl)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| TXA | Experimental | 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. Receives: Drug: Transexamic acid |
| Placebo | Placebo comparator | 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. Receives: Drug: Normal Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible participant enrollment within 12 months
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months.
Measured: 12 months
Secondary outcomes (8)
Percentage of enrolled participants who adhere to the study treatment within the trial.
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.
Measured: 6 months
Percentage of enrolled participants who complete the study's follow-up window
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.
Measured: 6 months
Percentage of consented participants among eligible participants who were approached
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.
Measured: 12 months
Logistical trial implementation barriers that might affect the full trial implementation
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.
Measured: 12 months
Percentage of wound complications assessed by the Foot and Ankle Postoperative Wound Classification scheme from 0 (no complication) to 7 (worse complication).
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.
Measured: 6 months
Percentage of re-operations following the initial total ankle arthroplasty
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.
Measured: 6 months
Percentage of participants with Prosthetic Joint Infection assessed by culture swab and treated with antibiotics
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.
Measured: 6 months
Percentage of participants with post-operative Venous Thromboembolism confirmed either via ultrasound or CT
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradley Meulenkamp, MD MSc FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828262
- Sponsor's protocol ID
- 4224
- Acronym
- TXA in TAR
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tranexamic Acid in Decreasing Wound Complication in Total Ankle Replacement. A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07828262
- Acronym / sponsor ID
- TXA in TAR / 4224
- Conditions
- Ankle Arthritis, Wound Complication
- Keywords
- ankle replacement, wound infection, total ankle arthroplasty, tranexamic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized, double-blind, placebo-controlled pilot trial designed to determine the feasibility of conducting a definitive multicentre randomized controlled trial evaluating intravenous and topical tranexamic acid (TXA) for reducing postoperative wound complications following primary total ankle replacement (TAR). The trial will also collect preliminary safety and clinical outcome data to estimate the potential effect of TXA on postoperative wound complications.
Patients with ankle arthritis scheduled to undergo primary TAR will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized in a 1:1 ratio to receive either intravenous and topical TXA or placebo (normal saline) administered according to the study protocol. Participants, treating surgeons, clinical staff, outcome assessors, and investigators will remain blinded to treatment allocation throughout the study.
All participants will undergo standard perioperative management and postoperative care as determined by their treating surgeon. Follow-up assessments will occur according to the routine postoperative schedule through six months after surgery. Data collected will include participant demographics, medical history, operative characteristics, study drug compliance, adverse events, and clinical outcomes.
The primary objective of this pilot trial is to determine the feasibility of conducting a definitive multicentre randomized controlled trial. Feasibility outcomes include participant recruitment, protocol adherence, treatment compliance, retention, completeness of follow-up, and completeness of outcome data collection.
Secondary objectives are to obtain preliminary estimates of the effect of intravenous TXA on postoperative wound complications and other clinically relevant outcomes, including surgical site infection, reoperation, blood transfusion, thromboembolic events, hospital readmission, and patient-reported outcome measures. Safety outcomes, including adverse events and serious adverse events, will also be monitored throughout the study.
The results of this pilot study will inform the design and implementation of a future adequately powered multicentre randomized controlled trial evaluating the effectiveness of intravenous TXA in improving outcomes following total ankle replacement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | Experimental | Drug: Transexamic acidPatients 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. |
| Placebo | Placebo comparator | Drug: Normal Saline (0.9% NaCl)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Patient receiving anticoagulation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transexamic acidPatients 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. | Drug | TXA |
| Normal Saline (0.9% NaCl)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. | Drug | Placebo |
Primary outcome
Percentage of eligible participant enrollment within 12 months
Time frame: 12 months
The primary feasibility outcome measure of the pilot trial is the overall recruitment rate based on the total recruitment over 12 months.
8 secondary outcomes
Percentage of enrolled participants who adhere to the study treatment within the trial.
Time frame: 6 months
Percentage of enrolled participants who complete the study's follow-up window
Time frame: 6 months
Percentage of consented participants among eligible participants who were approached
Time frame: 12 months
Logistical trial implementation barriers that might affect the full trial implementation
Time frame: 12 months
Percentage of wound complications assessed by the Foot and Ankle Postoperative Wound Classification scheme from 0 (no complication) to 7 (worse complication).
Time frame: 6 months
Percentage of re-operations following the initial total ankle arthroplasty
Time frame: 6 months
Percentage of participants with Prosthetic Joint Infection assessed by culture swab and treated with antibiotics
Time frame: 6 months
Percentage of participants with post-operative Venous Thromboembolism confirmed either via ultrasound or CT
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research Coordinator, BSc contact
Bradley Meulenkamp, MD MSc FRCSC principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transexamic acid and Normal Saline (0.9% NaCl) in people with Ankle Arthritis and Wound Complication, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator, MSc (6137378899 ext. 19217, hghaziasgar@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible participant enrollment within 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.