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

NCT04042688 | Unknown Phase 4 DMC

• 1 other identifier: GR0011
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 .

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• extent of pain

  1 day and 5days

• patellar circumference

  2days and 5days

• range of motion

  6 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: intraarticular administration of tranexamic acid

Control gorup

NO INTERVENTION

Interventions

intraarticular administration of tranexamic acid DRUG

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.

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• primary single bundle anterior cruciate ligament reconstruction using a hamstring autograft with or without meniscus surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32743011 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Jihoon Bae

  Department of Orthopaedic Surgery at Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: July 1, 2017
• Primary Completion: June 20, 2019
• Study Completion: August 30, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Locations

KR (1)