Anterior Cruciate Ligament Rupture Clinical 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
Verified date | August 2019 |
Source | Korea University Guro Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 .
Status | Active, not recruiting |
Enrollment | 47 |
Est. completion date | August 30, 2019 |
Est. primary completion date | June 20, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
2 days | |
Secondary | 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. | 1 day and 5days | |
Secondary | patellar circumference | The patellar circumference was measured transverse axis of the patella center to evaluate intra-articular effusion | 2days and 5days | |
Secondary | range of motion | The range of motion was documented as the extension and flexion degrees using an orthopaedic goniometer. | 6 weeks |
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