The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty

Thammasat University

Status and phase

Unknown

Phase 2

Conditions

Osteoarthritis,Knee

Treatments

Drug: Peri-articular TXA (15 mg/kg)

Procedure: TXA 40 mL inject into intraaricular knee capsule

Drug: Intraarticular TXA 2 g (40 mL)

Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area

Study type

Interventional

Funder types

Other

Identifiers

NCT03074994

MTU-EC-OT-6-063/59

Details and patient eligibility

About

Post-operative bleeding in total knee arthroplasty (TKA) can result in hypovolemic shock and unnecessity for allogenic blood transfusions. Intravenous and topical tranexamic acid (TXA) have been well established in reducing blood loss postoperatively. However, there are lack of data on peri-articular TXA injection during TKA. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial to compare the effectiveness of bleeding reduction of peri-articular TXA injections, intraarticular TXA injections and control group.

Full description

Patients scheduled for unilateral primary TKA; 108 patients were randomly assigned to receive peri-articular TXA, intraarticular TXA and control group. 36 patients received either: (I) 15 mg/kg peri-articular TXA combined with multimodal local anesthetic infiltration (bupivacaine, morphine, ketorolac and epinephrine) into the anterior soft tissue, medial gutter area, lateral gutter area prior to capsular closure and tourniquet deflation (group 1). (II) 2 g of intraarticular TXA after complete capsular closure just before tourniquet deflation (group 2). (III) Don't receive any route of TXA in control group (group 3). Hemoglobin (Hb) concentrations were measured at 24 and 48 hour, and the number of blood transfusions and knee circumference measurements were recorded. Serum TXA was recorded at 2 and 24 hours after operation. The reviewers were blinded to treatment group.

Enrollment

108 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients with osteoarthritis in need of a TKA

Exclusion criteria

Inflammatory arthritis
Post-traumatic arthritis
A history of or current venous thromboembolic disease
Any underlying disease of haemostasis, cirrhosis, chronic renal failure, patients on anticoagulants or strong antiplatelet drugs (e.g. warfarin, clopidogrel)
Preoperative hemoglobin <10 g/dL or a platelet count < 140,000 /uL3
Allergy to TXA

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

108 participants in 3 patient groups

Peri-articular tranexamic acid injection

Experimental group

Description:

TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue+Medial gutter area+Lateral gutter area)

Treatment:

Procedure: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area

Drug: Peri-articular TXA (15 mg/kg)

Intraarticular tranexamic acid injection

Experimental group

Description:

TXA inject into intraaricular knee capsule after multimodal local anesthetic infiltration

Treatment:

Drug: Intraarticular TXA 2 g (40 mL)

Procedure: TXA 40 mL inject into intraaricular knee capsule

Control group

No Intervention group