Trial Outcomes & Findings for Reducing Hemarthrosis in Tibial Tubercle Osteotomy by the Administration of Intravenous Tranexamic Acid (NCT NCT03606109)

NCT ID: NCT03606109

Last Updated: 2022-09-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: Perioperative, up to 2 hours
• Results posted on: 2022-09-21

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	31	27
Overall Study COMPLETED	29	26
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	High Tibial Osteotomy (HTO) n=29 Participants 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	Tibial Tubercle Ostetomy (TTO) n=26 Participants 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	Total n=55 Participants Total of all reporting groups
Age, Continuous	32.65 years STANDARD_DEVIATION 8.84 • n=29 Participants	34.37 years STANDARD_DEVIATION 8.06 • n=26 Participants	34.31 years STANDARD_DEVIATION 8.93 • n=55 Participants
Sex: Female, Male Female	15 Participants n=29 Participants	13 Participants n=26 Participants	28 Participants n=55 Participants
Sex: Female, Male Male	14 Participants n=29 Participants	13 Participants n=26 Participants	27 Participants n=55 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	29 participants n=29 Participants	26 participants n=26 Participants	55 participants n=55 Participants

PRIMARY outcome

Timeframe: Perioperative, up to 2 hours

Outcome measures

Measure	High Tibial Osteotomy (HTO) n=29 Participants 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	Tibial Tubercle Ostetomy (TTO) n=26 Participants 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	67.8 mL Standard Deviation 56.50	56.15 mL Standard Deviation 33.92

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Tibial Osteotomy (HTO) n=29 Participants 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	Tibial Tubercle Ostetomy (TTO) n=26 Participants 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
Score on Visual Analogue Scale (VAS) for Pain	7.13 score on a scale Standard Deviation 2.58	6.65 score on a scale Standard Deviation 2.66

SECONDARY outcome

Timeframe: Day 4

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.

Outcome measures

Measure	High Tibial Osteotomy (HTO) n=29 Participants 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	Tibial Tubercle Ostetomy (TTO) n=26 Participants 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
Score on Visual Analogue Scale (VAS) for Pain	5.82 score on a scale Standard Deviation 1.95	5.73 score on a scale Standard Deviation 2.26

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	High Tibial Osteotomy (HTO) n=29 Participants 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	Tibial Tubercle Ostetomy (TTO) n=26 Participants 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
Score on Visual Analogue Scale (VAS) for Pain	4.78 score on a scale Standard Deviation 1.76	4.77 score on a scale Standard Deviation 2.37

Adverse Events

High Tibial Osteotomy (HTO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tibial Tubercle Ostetomy (TTO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael J. Alaia, MD

NYU Langone Health

Phone: 646-501-7223

Email: Michael.Alaia@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place