Health TrialsbyHealthPanel

HTO and Tranexamic Acid Study

ConditionOsteoarthritis, Knee
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorWestern University, Canada

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid

    Drug

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

  • Routine medial opening wedge high tibial osteotomy

    Procedure/Surgery

    Standard of Care: routine medial opening wedge high tibial osteotomy

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: SOC + Tranexamic AcidExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western University, Canada

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: