RecruitingPhase 3ACTRN12618000734268

A Comparative Outcome Study Using Tranexamic Acid in Arthroscopic Medial Meniscectomy

A Comparative Outcome Study Using Tranexamic Acid for pain in patients undergoing Arthroscopic Medial Meniscectomy


Sponsor

Professor Gary Hooper

Enrollment

40 participants

Start Date

Apr 16, 2018

Study Type

Interventional

Conditions

Summary

Arthroscopic meniscectomy is an established procedure with known benefits in the correct patient population. Common complications associated with arthroscopic knee procedures are haemarthrosis, swelling, decreased range of motion, increased pain and infection. Previous methods for decreasing postoperative haemarthrosis and swelling have been drain placement and compressive dressings. TXA is a lysine based inhibitor of plasminogen to plasmin which has gained popularity in orthopaedic practice in the past decade after being shown to decrease blood loss. TXA administered intravenously has also been shown as safe with regards to events such as venous thromboembolism (VTE) and acute renal failure. A recent double blinded level 1 evidence prospective randomized controlled trial has also shown the benefit of TXA in arthroscopic ACL reconstructions in reducing postoperative hemarthrosis, swelling, and pain while increasing function in the short term. The safety of TXA has been well documented in the orthopaedic literature as well as other surgical fields for the purpose of reduction of blood loss. In 2006, a Cochrane review that included 65 trials that compared TXA versus control. These trials included a total of 4842 patients and showed that the use of TXA was not associated with an increased risk of MI, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) or renal failure. Specifically in the orthopaedic literature, a meta analysis compared the rate of VTE in patients undergoing knee and hip arthroplasty, none showing an increased risk of VTE associated with the use of TXA compared to control. Further to this, there are large joint registry retrospective cohort studies that have also shown no association with the use of TXA and increased risk of VTE. The goal of this pilot study is to determine if there is a role for TXA in improving short term results and patient satisfaction in arthroscopic knee meniscectomies.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

When a torn meniscus (the cartilage cushion inside the knee) is removed using keyhole surgery — a procedure called arthroscopic meniscectomy — one of the most common aftereffects is swelling inside the joint caused by blood pooling there (haemarthrosis). This can cause pain, stiffness, and slower recovery. A drug called tranexamic acid (TXA), which helps blood clot more effectively, has been shown to reduce this problem in other knee surgeries, but it hasn't been specifically tested for meniscus removal. This pilot study is investigating whether giving TXA during arthroscopic meniscectomy reduces post-operative swelling, pain, and discomfort, and speeds up recovery and patient satisfaction. It's designed to gather enough information to plan a larger, definitive trial. You may be eligible if you are 18 or older and scheduled to undergo arthroscopic knee surgery specifically for a torn meniscus. You should not have a history of bleeding or clotting disorders, be pregnant, be on blood-thinning medications, have kidney problems, an allergy to TXA or local anaesthetics, significant knee swelling already present, or other concurrent knee ligament injuries. If you're facing meniscus surgery and want to help advance recovery protocols, this study could be relevant to you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The dose of 1 gram if tranexamic acid intravenously administered by the anaesthetist under supervision of the lead researcher will be given at induction prior to tourniquet inflation in 100 ml of norm

The dose of 1 gram if tranexamic acid intravenously administered by the anaesthetist under supervision of the lead researcher will be given at induction prior to tourniquet inflation in 100 ml of normal saline as a single bolus.


Locations(1)

Canterbury, New Zealand

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ACTRN12618000734268