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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000734268
Enrollment
8
Registered
2018-05-02
Start date
2018-04-16
Completion date
2018-07-02
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 normal saline as a single bolus.

Sponsors

Professor Gary Hooper
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients at the offices of the primary surgeon with the intention of undergoing an arthroscopic meniscectomy will be screened for enrolment at the preoperative clinic using a screening form Indication for meniscectomy includes but is not limited to a patient presenting with painful knee with locking, clicking or instability with examination findings of McMurray's test positive, tender joint line having an isolated meniscal tear on MRI and having trailed period of nonoperative management with no other cause for knee pain identified.

Exclusion criteria

Our exclusion criteria will be younger than 18 years old, a history of bleeding or clotting disorder, pregnancy, preoperative anticoagulation therapy, renal disorder, allergy to local anesthetics or tranexamic acid, large preoperative swelling (grade 3 or 4 effusion), concurrent ligament injury, prior anterior cruciate ligament reconstruction, microfracture or a revision surgery.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026