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

Tibial Tubercle Osteotomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606109
• Other study ID #: 18-00535
• Status: Completed
• Phase: Phase 4
• Start date: June 26, 2018
• Est. completion date: June 2, 2021

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Not Provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemarthrosis
• Tibial Tubercle Osteotomy

Intervention

Drug:
• Tranexamic Acid (TXA)
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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Blood Loss		Perioperative, up to 2 hours
Secondary	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
Secondary	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
Secondary	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