Anterior Cruciate Ligament Reconstruction
Conditions
Brief summary
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain.
Detailed description
The purpose of the proposed study is to evaluate the effects of administering intravenous tranexamic acid (TXA) to patients undergoing anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone autograft to minimize hemarthrosis within the knee joint and post operative pain. Patients received the standard arthroscopic ACL reconstruction with a BTB autograft and were randomized to either receiving or not receiving two individual doses of TXA intra-operatively or receive. The goal of the study is to determine and evaluate the effect of intra-operative TXA on post-operative hemarthrosis, pain reduction, and opioid consumption.
Interventions
DRUGTranexamic Acid
One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
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 AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT
Exclusion criteria
* Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.) * Younger than 18 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 | Description |
|---|---|---|
| POST-OPERATIVE HEMARTHROSIS | Post-operative week 1 | Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration. |
| POST-OPERATIVE Opioid Consumption | Days 1-7 | Each patient's opioid consumption was measured by morphine milligram equivalents (MME). |
| POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | Post-operative day 7 | Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACL Reconstruction w/ BTB Autograft + IV TXA Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision. | 55 |
| ACL Reconstruction w/ BTB Autograft, no IV TXA Received a standard ACL Reconstruction w/ BTB Autograft without IV Tranexamic Acid | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
Baseline characteristics
| Characteristic | ACL Reconstruction w/ BTB Autograft + IV TXA | ACL Reconstruction w/ BTB Autograft, no IV TXA | Total |
|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 5.8 | 29.7 years STANDARD_DEVIATION 8.5 | 29.1 years STANDARD_DEVIATION 7.3 |
| Body Mass Index (kg/m^2) | 26.8 kg/m^2 STANDARD_DEVIATION 5.2 | 26.1 kg/m^2 STANDARD_DEVIATION 5.2 | 26.4 kg/m^2 STANDARD_DEVIATION 5.2 |
| Meniscal Repair (Yes, No) Meniscal Repair (No) | 40 Participants | 41 Participants | 81 Participants |
| Meniscal Repair (Yes, No) Meniscal Repair (Yes) | 15 Participants | 14 Participants | 29 Participants |
| Meniscectomy (Yes, No) Meniscectomy (No) | 31 Participants | 32 Participants | 63 Participants |
| Meniscectomy (Yes, No) Meniscectomy (Yes) | 24 Participants | 23 Participants | 47 Participants |
| Operative Knee (Right, Left) Operative Knee (Left) | 21 Participants | 26 Participants | 47 Participants |
| Operative Knee (Right, Left) Operative Knee (Right) | 34 Participants | 29 Participants | 63 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 55 participants | 55 participants | 110 participants |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 45 Participants |
| Sex: Female, Male Male | 30 Participants | 35 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
POST-OPERATIVE HEMARTHROSIS
Measured by assessing the operative knee at the first post-operative visit for the need of joint aspiration.
Time frame: Post-operative week 1
Population: The patients in each respective arm were evaluated for knee joint hemarthrosis and prompted joint aspiration because of pain or significant swelling.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACL Reconstruction w/ BTB Autograft + IV TXA | POST-OPERATIVE HEMARTHROSIS | 26.7 ml | Standard Deviation 23.1 |
| ACL Reconstruction w/ BTB Autograft, no IV TXA | POST-OPERATIVE HEMARTHROSIS | 37.3 ml | Standard Deviation 23.2 |
Primary
POST-OPERATIVE Opioid Consumption
Each patient's opioid consumption was measured by morphine milligram equivalents (MME).
Time frame: Days 1-7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACL Reconstruction w/ BTB Autograft + IV TXA | POST-OPERATIVE Opioid Consumption | 130.9 MME | Standard Deviation 90.9 |
| ACL Reconstruction w/ BTB Autograft, no IV TXA | POST-OPERATIVE Opioid Consumption | 113.9 MME | Standard Deviation 85 |
Primary
POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS)
Pain severity, measured by the Visual Analog Scale (VAS): a scale of 1-10, with 1 being the least amount of pain and 10 being the most amount of pain.
Time frame: Post-operative day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACL Reconstruction w/ BTB Autograft + IV TXA | POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | 2.7 score on a scale | Standard Deviation 1.9 |
| ACL Reconstruction w/ BTB Autograft, no IV TXA | POST-OPERATIVE Patient Reported Pain Score on the Visual Analog Scale (VAS) | 3.2 score on a scale | Standard Deviation 1.8 |