Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid

Study Overview
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Brief Summary
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The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing high tibial osteotomy (HTO) and tibial tubercle osteotomy (TTO) to minimize hemarthrosis within the knee joint and post operative pain and swelling.

Detailed Description
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Not Provided

Official Title
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Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid

Conditions
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Tibial Tubercle Osteotomy

Intervention / Treatment
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* Drug: Tranexamic Acid (TXA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing TTO Age 18-60 Willing and able to provide consent Exclusion Criteria: Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) Younger than 18 years of age Older than 60 years of age Any patient considered a vulnerable subject Have bleeding or clotting disorder Preoperative anticoagulation therapy Abnormal coagulation profile Renal disorder or insufficiency Sickle cell disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Tibial Osteotomy (HTO)<br> | Drug: Tranexamic Acid (TXA)<br>* One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects<br>|
| Active Comparator: Tibial Tubercle Ostetomy (TTO)<br> | Drug: Tranexamic Acid (TXA)<br>* One gram of intravenous tranexamic acid (TXA) will be administrated before tourniquet inflation and before closure of the incision, as 1 g has been shown to be a safe amount with minimal side effects<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Blood Loss |  | Perioperative, up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on Visual Analogue Scale (VAS) for Pain | VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. | Day 1 | 
| Score on Visual Analogue Scale (VAS) for Pain | VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. | Day 4 | 
| Score on Visual Analogue Scale (VAS) for Pain | VAS will be used to report post-operative pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tibial Tubercle Osteotomy, Tranexamic Acid