A Phase 3 interventional study of Tranexamic Acid and Routine medial opening wedge high tibial osteotomy in Osteoarthritis, Knee, sponsored by Western University, Canada. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Western University, Canada · Phase 3, Interventional, and Prevention
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.
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 200 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Western University, Canada is the lead sponsor of 224 studies on the registry; 56 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Administration of 15 mg/kg intravenous Tranexamic Acid at the beginning of the surgical procedure/surgical pause
Also known as: TEA
Standard of Care: routine medial opening wedge high tibial osteotomy
Also known as: HTO
Haemoglobin (g/L) value
To prospectively evaluate the effect of tranexamic acid in reducing blood loss during High Tibial Osteotomy
Time frame: Change between the patient's pre-operative blood draw (day of surgery) and that collected on day 1 post-operatively.
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.
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)
To determine the potential benefit in wound healing
Time frame: 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.
Time frame: 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.
Time frame: 2 & 6 weeks post-op
No study locations are listed for this record.
Start is estimated for Jan 2027; primary completion for Jan 2030, 36 months later.
Of 35 non-industry phase 3 interventional studies under Osteoarthritis, Knee, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 36 months is above that.
Counting every sponsor, half of 100 studies reached it within 21 months; a quarter within 15 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tranexamic Acid