NCT07825350

Brief 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). 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
61mo left

Started Jan 2027

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2018

Completed
8.6 years until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2032

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

February 27, 2018

Last Update Submit

September 11, 2026

Conditions

Osteoarthritis, Knee

Keywords

KneeOsteoarthritisRealignment

Outcome Measures

Primary Outcomes (1)

  • Haemoglobin (g/L) value

    To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy

    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)

    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)

    2 & 6 weeks, 3 & 6 months post-op

  • Measurement of Calf Circumference

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

  • Visual Analog Pain Scale

    2 & 6 weeks post-op

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Patients will undergo routine medial opening wedge high tibial osteotomy by one of five fellowship trained orthopaedic surgeons.

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.

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

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

Also known as: TEA
SOC + Tranexamic Acid
Routine medial opening wedge high tibial osteotomyPROCEDURE

Standard of Care: routine medial opening wedge high tibial osteotomy

Also known as: HTO
Standard of Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Interventions

Tranexamic AcidTea

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Kevin Willits, MD, FRCSC

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Ambrose

CONTACT

519-661-2111ashley.ambrose@lhsc.on.ca

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2018

First Posted

September 17, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2032

Last Updated

September 17, 2026

Record last verified: 2026-09