Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intraarticular administration of tranexamic acid
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
Eligibility Criteria
Inclusion Criteria:
- primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries
Exclusion Criteria:
- use of other grafts (allograft, bone patellar tendon bone autograft)
- revision anterior cruciate ligament reconstruction,
- concomitant knee cartilage or collateral ligament surgeries
- history of knee surgery on affected knee
- concomitant fracture
- significnat preoperative pain (Visual analoge score >5)
- coagulation or bleeding disorders
- preoperative anticoagulation treatment
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control gorup
Arm Description
Patients were randomly allocated to one of two groups during preoperative preparation by computer-generated randomization. Treatment group; IA administration of TXA, control group; no TXA administration
Outcomes
Primary Outcome Measures
blood loss
Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused.
Secondary Outcome Measures
extent of pain
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain.
patellar circumference
The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion
range of motion
The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
Full Information
NCT ID
NCT04042688
First Posted
August 1, 2019
Last Updated
August 1, 2019
Sponsor
Korea University Guro Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04042688
Brief Title
Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Official Title
Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
August 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Korea University Guro Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to investigate whether intraarticular administration of tranexamic acid could reduce hemarthrosis and postoperative pain in patients following anterior cruciate ligament reconstruction. The hypothesis of the study was that patients treated with intraarticular tranexamic acid would have significantly less postoperative hemarthrosis and less pain in the early phase of the rehabilitation process compared with those without intraarticular tranexamic acid .
Detailed Description
Intervention Based on the previous studies, intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
Outcome Demographic variables (age, sex, body mass index, and time from injury to surgery), clinical outcomes and surgical records including operative time, bleeding amounts, meniscus and cartilage lesions were collected by an independent orthopaedic resident. Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 (PD 1) and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain. The other secondary outcomes included mid-patellar circumference at postoperative day 2 and day 5 and knee range of motion after 6 weeks from operation, which were measured by an independent orthopaedic fellow. The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion. To minimize inter-observer variance of the patellar circumference, we considered the difference between the preoperative and the postoperative results. The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients were randomly allocated to one of two groups during preoperative preparation by computer-generated randomization. Treatment group; IA administration of TXA, control group; no TXA administration
Arm Title
Control gorup
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
intraarticular administration of tranexamic acid
Intervention Description
Intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
Primary Outcome Measure Information:
Title
blood loss
Description
Primary outcome was a blood loss calculated based on hemoglobin balance. We assumed that blood volume in ml on the second day after surgery was the same as that before surgery. Blood volume was estimated according to the method of Nadler and colleagues taking sex, body mass and height into account. The loss of Hemoglobin was then estimated according to the formula.
Hemoglobin loss=Blood volume*(Hemoglobin concentration before surgery - Hemoglobin concentration after surgery)*0.001+total amount of allogenic hemoglobin transfused.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
extent of pain
Description
The secondary outcome was an extent of pain measured by a visual analog scale at a consistent time in the afternoon of postoperative day 1 and for the next 4 day.The pain visual analog scale is a numeric response on a scale from 0 to 10, with 0 denoting no pain and 10 signifying severe pain.
Time Frame
1 day and 5days
Title
patellar circumference
Description
The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion
Time Frame
2days and 5days
Title
range of motion
Description
The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer.
Time Frame
6 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries
Exclusion Criteria:
use of other grafts (allograft, bone patellar tendon bone autograft)
revision anterior cruciate ligament reconstruction,
concomitant knee cartilage or collateral ligament surgeries
history of knee surgery on affected knee
concomitant fracture
significnat preoperative pain (Visual analoge score >5)
coagulation or bleeding disorders
preoperative anticoagulation treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihoon Bae
Organizational Affiliation
Department of Orthopaedic Surgery at Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32743011
Citation
Lee JW, Kim SG, Kim SH, Cho HW, Bae JH. Intra-articular Administration of Tranexamic Acid Has No Effect in Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary ACL Reconstruction Using a Quadruple Hamstring Graft: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Jul 22;8(7):2325967120933135. doi: 10.1177/2325967120933135. eCollection 2020 Jul.
Results Reference
derived
Learn more about this trial
Intra-articular Administration of 3.0g Tranexamic Acid Has no Effect on Reducing Intra-articular Hemarthrosis and Postoperative Pain After Primary Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
We'll reach out to this number within 24 hrs