Back to resultsReducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Primary Purpose
Tibial Tubercle Osteotomy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid (TXA)
Sponsored by
About this trial
This is an interventional treatment trial for Tibial Tubercle Osteotomy focused on measuring Tibial Tubercle Osteotomy, Tranexamic Acid
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High Tibial Osteotomy (HTO)
Tibial Tubercle Ostetomy (TTO)
Arm Description
Outcomes
Primary Outcome Measures
Perioperative Blood Loss
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03606109
Brief Title
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Official Title
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 26, 2018 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Tubercle Osteotomy
Keywords
Tibial Tubercle Osteotomy, Tranexamic Acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Tibial Osteotomy (HTO)
Arm Type
Active Comparator
Arm Title
Tibial Tubercle Ostetomy (TTO)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid (TXA)
Intervention Description
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
Primary Outcome Measure Information:
Title
Perioperative Blood Loss
Time Frame
Perioperative, up to 2 hours
Secondary Outcome Measure Information:
Title
Score on Visual Analogue Scale (VAS) for Pain
Description
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
Title
Score on Visual Analogue Scale (VAS) for Pain
Description
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
Title
Score on Visual Analogue Scale (VAS) for Pain
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Alaia, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
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