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

Phase 4

Completed

• Conditions: Tibial Tubercle Osteotomy
• Interventions: Drug: Tranexamic Acid (TXA)

• Registration Number: NCT03606109
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not Provided

Study Timeline

• Study First Submitted: 2018-05-22
• Study Start: 2018-06-26
• Study First Submitted QC: 2018-07-27
• Study First Posted: 2018-07-30
• Primary Completion: 2021-06-02
• Study Completion: 2021-06-02
• Status Verified: 2022-08
• Results First Submitted: 2022-08-05
• Results First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Results First Posted: 2022-09-21
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Patients undergoing TTO
• Age 18-60
• Willing and able to provide consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Tibial Osteotomy (HTO)	Tranexamic Acid (TXA)	-
Tibial Tubercle Ostetomy (TTO)	Tranexamic Acid (TXA)	-

Primary Outcome Measures

Name	Time	Method
Perioperative Blood Loss	Perioperative, up to 2 hours

Secondary Outcome Measures

Name	Time	Method
Score on Visual Analogue Scale (VAS) for Pain	Day 7	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States