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
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 .
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.
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