Tibial Tubercle Osteotomy Clinical Trial
Official title:
Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid
NCT number | NCT03606109 |
Other study ID # | 18-00535 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 26, 2018 |
Est. completion date | June 2, 2021 |
Verified date | August 2022 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05759039 -
SHould You transFer the Tubercle?
|
N/A |