Osteoarthritis, KneePhase 3NCT07825350
HTO and Tranexamic Acid Study
A Phase 3 study testing Tranexamic Acid and Routine medial opening wedge high tibial osteotomy in people with Osteoarthritis, Knee, run by Western University, Canada.
Trial summary
The purpose of the study is to assess the effect of Tranexamic acid (TXa), a commonly used medication to prevent bleeding, in reducing blood loss during High Tibial Osteotomy (HTO). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Tranexamic Acid and Routine medial opening wedge high tibial osteotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2032
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with mechanical varus alignment and knee OA according to Rheumatology classification criteria (Altman, 1986), with the greatest severity in the medial compartment of the tibiofemoral joint
- Undergoing Medial opening wedge high tibial osteotomy by or under guidance from Fellowship Trained Sports Orthopaedic Surgeons
Who cannot join
- Allergy to tranexamic acid. Acquired disturbances of colour vision, preoperative use of anticoagulants within 5 days of surgery, coagulopathy as described by pre-op platelet count of <150,000/mm3, pregnancy, breast feeding (From Wong, 2010)
- Inflammatory or infectious arthritis. Major neurologic deficit. (From Birmingham, 2009)
- Prior history of venous thrombotic event being treated with life-long anticoagulation.
- Patients known to have congenital thrombophilia, and patients who have had a known venous thromboembolic event within 1 year preceding surgery. (From Ralley 2010)
- Patients taking hormonal contraceptives, Factor IX complex concentrates, anti-inhibitor coagulant concentrates, thrombin, batroxobin or haemocoagulase. These medications could potentially increase thrombotic risk if taken concomitantly with tranexamic acid (McCormack, 2012)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Tranexamic Acid in the Reduction of Postoperative Complications Following Medial Opening Wedge High Tibial Osteotomy
The purpose of the study is to assess the effect of Tranexamic acid (TXa), a commonly used medication to prevent bleeding, in reducing blood loss during High Tibial Osteotomy (HTO). HTO is a common procedure aimed at realigning patients that are bow-legged, in an attempt to reduce pain associated with osteoarthritis of the knee, and to prevent its progression. A secondary aim is to assess the effect of TXa in preventing side-effects of surgery related to the healing of surgical wound.
Read the detailed description
Medial opening wedge high tibial osteotomy (MOW HTO) is an effective treatment of varus malalignment with associated medial compartment osteoarthritis, medial compartment osteochondral defect, and instability (1-3). Although this technique was developed to limit complications relative to its counterpart, the lateral closing wedge high tibial osteotomy, adverse events occur in up to 55% of cases. Martin et al stratified these adverse events and described the overall complication rate requiring further surgical management or long-term medical care to be 7%. Their stratification included 1) adverse events requiring no additional treatment such as delayed wound healing (6%) and hematoma (3%), 2) adverse events requiring extended non-operative management such as cellulitis (10%) and deep vein thrombosis (1%), and 3) adverse events requiring additional surgery such as deep infection (2%)(3).
There is emerging evidence that Tranexamic Acid (TEA) can safely and effectively decrease blood loss in patients undergoing HTO. Whilst rare, this may reduce the need for post-operative blood transfusions. There is also emerging evidence that TEA has a role in infection prevention in open reduction and internal fixation of traumatic fractures, as well as a decreased periprosthetic infection risk in hip and knee arthroplasty (4,5). This is thought to occur by indirect mechanisms such as the prevention of haematoma, but also direct mechanism through prevention of biofilm formation. There has not been a high-quality randomised controlled trial to demonstrate this effect however.
The Patient Observer Scar Assessment Scale (POSAS) is a widely used and validated clinical assessment tool that measures differences in wound-related outcomes(6). It is a sensitive measure of subtle changes in scar and wound healing due to treatment effect and can be used in addition to binary wound complication outcomes such as cellulitis, haematoma, purulence.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Tranexamic Acid, Routine medial opening wedge high tibial osteotomy
- Keywords
- Knee, Osteoarthritis, Realignment
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TEA
Administration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause
Routine medial opening wedge high tibial osteotomyProcedure or surgery
Also called HTO
Standard of Care: routine medial opening wedge high tibial osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Patients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons. Receives: Procedure: Routine medial opening wedge high tibial osteotomy |
| SOC + Tranexamic Acid | Experimental | Patients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons with the addition of administration of 20 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin (g/L) value
To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy
Measured: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.
Secondary outcomes (4)
Knee injury and Osteoarthritis Outcome Score (KOOS)
To determine the potential decrease in patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Measured: Pre-op (up to 6 months before surgery) , 2 & 6 weeks post -op, 3 & 6 months post-op
Patient and Observer Scar Assessment Scale (POSAS)
To determine the potential benefit in wound healing
Measured: 2 & 6 weeks, 3 & 6 months post-op
Measurement of Calf Circumference
To determine the potential decrease in post-operative complications, and patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Measured: pre-operatively (up to 6 months prior to surgery), post-op 2 & 6 weeks
Visual Analog Pain Scale
To determine the potential decrease in post-operative complications, and patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.
Measured: 2 & 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Willits, MD, FRCSC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825350
- Sponsor's protocol ID
- 110833
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2018
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in the Reduction of Postoperative Complications Following Medial Opening Wedge High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT07825350
- Acronym / sponsor ID
- 110833
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee, Osteoarthritis, Realignment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 17 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.
The purpose of the study is to assess the effect of Tranexamic acid (TXa), a commonly used medication to prevent bleeding, in reducing blood loss during High Tibial Osteotomy (HTO). HTO is a common procedure aimed at realigning patients that are bow-legged, in an attempt to reduce pain associated with osteoarthritis of the knee, and to prevent its progression. A secondary aim is to assess the effect of TXa in preventing side-effects of surgery related to the healing of surgical wound.
Detailed description
Medial opening wedge high tibial osteotomy (MOW HTO) is an effective treatment of varus malalignment with associated medial compartment osteoarthritis, medial compartment osteochondral defect, and instability (1-3). Although this technique was developed to limit complications relative to its counterpart, the lateral closing wedge high tibial osteotomy, adverse events occur in up to 55% of cases. Martin et al stratified these adverse events and described the overall complication rate requiring further surgical management or long-term medical care to be 7%. Their stratification included 1) adverse events requiring no additional treatment such as delayed wound healing (6%) and hematoma (3%), 2) adverse events requiring extended non-operative management such as cellulitis (10%) and deep vein thrombosis (1%), and 3) adverse events requiring additional surgery such as deep infection (2%)(3).
There is emerging evidence that Tranexamic Acid (TEA) can safely and effectively decrease blood loss in patients undergoing HTO. Whilst rare, this may reduce the need for post-operative blood transfusions. There is also emerging evidence that TEA has a role in infection prevention in open reduction and internal fixation of traumatic fractures, as well as a decreased periprosthetic infection risk in hip and knee arthroplasty (4,5). This is thought to occur by indirect mechanisms such as the prevention of haematoma, but also direct mechanism through prevention of biofilm formation. There has not been a high-quality randomised controlled trial to demonstrate this effect however.
The Patient Observer Scar Assessment Scale (POSAS) is a widely used and validated clinical assessment tool that measures differences in wound-related outcomes(6). It is a sensitive measure of subtle changes in scar and wound healing due to treatment effect and can be used in addition to binary wound complication outcomes such as cellulitis, haematoma, purulence.
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 |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Routine medial opening wedge high tibial osteotomyPatients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons. |
| SOC + Tranexamic Acid | Experimental | Drug: Tranexamic AcidPatients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons with the addition of administration of 20 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with mechanical varus alignment and knee OA according to Rheumatology classification criteria (Altman, 1986), with the greatest severity in the medial compartment of the tibiofemoral joint
- Undergoing Medial opening wedge high tibial osteotomy by or under guidance from Fellowship Trained Sports Orthopaedic Surgeons
Key exclusion criteria (5 listed)
- Allergy to tranexamic acid. Acquired disturbances of colour vision, preoperative use of anticoagulants within 5 days of surgery, coagulopathy as described by pre-op platelet count of <150,000/mm3, pregnancy, breast feeding (From Wong, 2010)
- Inflammatory or infectious arthritis. Major neurologic deficit. (From Birmingham, 2009)
- Prior history of venous thrombotic event being treated with life-long anticoagulation.
- Patients known to have congenital thrombophilia, and patients who have had a known venous thromboembolic event within 1 year preceding surgery. (From Ralley 2010)
- Patients taking hormonal contraceptives, Factor IX complex concentrates, anti-inhibitor coagulant concentrates, thrombin, batroxobin or haemocoagulase. These medications could potentially increase thrombotic risk if taken concomitantly with tranexamic acid (McCormack, 2012)
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 |
|---|---|---|
| Tranexamic AcidAlso: TEAAdministration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause | Drug | SOC + Tranexamic Acid |
| Routine medial opening wedge high tibial osteotomyAlso: HTOStandard of Care: routine medial opening wedge high tibial osteotomy | Procedure or surgery | Standard of Care |
Primary outcome
Haemoglobin (g/L) value
Time frame: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.
To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy
4 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Pre-op (up to 6 months before surgery) , 2 & 6 weeks post -op, 3 & 6 months post-op
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 2 & 6 weeks, 3 & 6 months post-op
Measurement of Calf Circumference
Time frame: pre-operatively (up to 6 months prior to surgery), post-op 2 & 6 weeks
Visual Analog Pain Scale
Time frame: 2 & 6 weeks post-op
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 17 Sep 2026.
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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.
Kevin Willits, MD, FRCSC principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid and Routine medial opening wedge high tibial osteotomy in people with Osteoarthritis, Knee, run by Western University, 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 2 inclusion and 5 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ashley Ambrose (519-661-2111 ext. 87528, ashley.ambrose@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemoglobin (g/L) value (time frame: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.). 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 17 Sep 2026.