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NCT Number: NCT07825350

HTO and Tranexamic Acid Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Tranexamic Acid

Drug

Administration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause

Other names: TEA

Routine medial opening wedge high tibial osteotomy

Procedure

Standard of Care: routine medial opening wedge high tibial osteotomy

Other names: HTO

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    To determine the potential decrease in patient satisfaction following medial opening wedge high tibial osteotomy secondary to the administration of Tranexamic Acid.

  2. Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 2 & 6 weeks, 3 & 6 months post-op

    To determine the potential benefit in wound healing

  3. Measurement of Calf Circumference

    Time frame: pre-operatively (up to 6 months prior to surgery), post-op 2 & 6 weeks

    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.

  4. Visual Analog Pain Scale

    Time frame: 2 & 6 weeks post-op

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Ambrose

CONTACT

[email protected]

519-661-2111 ext. 87528

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Efficacy of Tranexamic Acid in the Reduction of Postoperative Complications Following Medial Opening Wedge High Tibial Osteotomy

Important dates

Study start
2027
Primary completion
2030
Study completion
2032
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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