A Phase 4 interventional study of Tranexamic Acid (TXA) in Tibial Tubercle Osteotomy, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by NYU Langone Health · Phase 4, Interventional, and Treatment
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
Exclusion Criteria:
Drug: Tranexamic Acid (TXA)
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
Perioperative Blood Loss
Time frame: Perioperative, up to 2 hours
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
| Milestone | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) |
|---|---|---|
| Started | 31 | 27 |
| Completed | 29 | 26 |
| Not completed | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 |
| mL | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) |
|---|---|---|
| Perioperative Blood Loss | 67.8 ± 56.50 | 56.15 ± 33.92 |
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 a scale | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) |
|---|---|---|
| Score on Visual Analogue Scale (VAS) for Pain | 7.13 ± 2.58 | 6.65 ± 2.66 |
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 a scale | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) |
|---|---|---|
| Score on Visual Analogue Scale (VAS) for Pain | 5.82 ± 1.95 | 5.73 ± 2.26 |
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 a scale | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) |
|---|---|---|
| Score on Visual Analogue Scale (VAS) for Pain | 4.78 ± 1.76 | 4.77 ± 2.37 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Tibial Osteotomy (HTO) | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Tibial Tubercle Ostetomy (TTO) | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Age, Continuous(years) | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) | Total |
|---|---|---|---|
| Mean | 32.65 ± 8.84 | 34.37 ± 8.06 | 34.31 ± 8.93 |
| Sex: Female, Male(Participants) | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 14 | 13 | 27 |
| Race and Ethnicity Not Collected(Participants) | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | High Tibial Osteotomy (HTO) | Tibial Tubercle Ostetomy (TTO) | Total |
|---|---|---|---|
| United States | 29 | 26 | 55 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health