Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

Konkuk University Medical Center122 enrolled

Overview

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Rotator Cuff Tears

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-80 years * Diagnosed with a rotator cuff tear * Failure of conservative treatment for more than 3 months * Rotator cuff deemed repairable on magnetic resonance imaging Exclusion Criteria: * Known hypersensitivity to tranexamic acid * Previous cerebrovascular accident * Coronary stent or other history of thromboembolic disease * Anticoagulant therapy * Uncontrolled hypertension (systolic pressure \> 180 mmHg) * Abnormal prothrombin time or activated partial thromboplastin time * Acute traumatic rotator cuff tear * Irreparable rotator cuff tear

Outcomes

Primary Outcomes

Intraoperative visual clarity

Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.

Time frame: Intraoperatively, at the end of each of the six surgical stages

Secondary Outcomes

Total operative time

Total duration of the surgical procedure.

Time frame: Intraoperative (duration of surgery)

Estimated blood loss

Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al.

Time frame: From immediately before surgery to immediately after the end of surgery

Irrigation-fluid volume

Total volume of irrigation fluid used during the procedure.

Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)

Number of irrigation-pressure increases

Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field

Time frame: Intraoperatively, from skin incision to skin closure (duration of surgery)

Postoperative shoulder swelling

Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted \~30 degrees, compared between pre-operative and postoperative day 1

Time frame: Baseline (pre-operative) and postoperative day 1

Postoperative pain

Pain assessed using a visual analog scale (VAS) on postoperative day 1

Time frame: Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1