Tibial Tubercle Osteotomy
Conditions
Keywords
Tibial Tubercle Osteotomy, Tranexamic Acid
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
Interventions
DRUGTranexamic 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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative Blood Loss | Perioperative, up to 2 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on Visual Analogue Scale (VAS) for Pain | Day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Tibial Osteotomy (HTO) 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 | 29 |
| Tibial Tubercle Ostetomy (TTO) 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 | 26 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Tibial Tubercle Ostetomy (TTO) | Total | High Tibial Osteotomy (HTO) |
|---|---|---|---|
| Age, Continuous | 34.37 years STANDARD_DEVIATION 8.06 | 34.31 years STANDARD_DEVIATION 8.93 | 32.65 years STANDARD_DEVIATION 8.84 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 26 participants | 55 participants | 29 participants |
| Sex: Female, Male Female | 13 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Male | 13 Participants | 27 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 27 |
| other Total, other adverse events | 0 / 31 | 0 / 27 |
| serious Total, serious adverse events | 0 / 31 | 0 / 27 |
Outcome results
Primary
Perioperative Blood Loss
Time frame: Perioperative, up to 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Tibial Osteotomy (HTO) | Perioperative Blood Loss | 67.8 mL | Standard Deviation 56.5 |
| Tibial Tubercle Ostetomy (TTO) | Perioperative Blood Loss | 56.15 mL | Standard Deviation 33.92 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Tibial Osteotomy (HTO) | Score on Visual Analogue Scale (VAS) for Pain | 7.13 score on a scale | Standard Deviation 2.58 |
| Tibial Tubercle Ostetomy (TTO) | Score on Visual Analogue Scale (VAS) for Pain | 6.65 score on a scale | Standard Deviation 2.66 |
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.
Time frame: Day 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Tibial Osteotomy (HTO) | Score on Visual Analogue Scale (VAS) for Pain | 5.82 score on a scale | Standard Deviation 1.95 |
| Tibial Tubercle Ostetomy (TTO) | Score on Visual Analogue Scale (VAS) for Pain | 5.73 score on a scale | Standard Deviation 2.26 |
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.
Time frame: Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Tibial Osteotomy (HTO) | Score on Visual Analogue Scale (VAS) for Pain | 4.78 score on a scale | Standard Deviation 1.76 |
| Tibial Tubercle Ostetomy (TTO) | Score on Visual Analogue Scale (VAS) for Pain | 4.77 score on a scale | Standard Deviation 2.37 |