NCT03606109 - Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid | Crick

Overview

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.

Not Provided

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

58

Conditions

Tibial Tubercle Osteotomy

Interventions

Tranexamic Acid (TXA)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

Perioperative Blood Loss

Time frame: Perioperative, up to 2 hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Day 7