This prospective randomized controlled trial aims to evaluate the efficacy and safety of intraosseous tranexamic acid administration during arthroscopic rotator cuff repair. Eligible patients undergoing arthroscopic rotator cuff repair will be randomly assigned in a 1:1 ratio to receive either intraosseous tranexamic acid or intraosseous normal saline placebo. Tranexamic acid will be administered at a dose of 15 mg/kg through intraosseous injection into the proximal humerus after anesthesia induction.
The primary outcome will be intraoperative arthroscopic visual clarity assessed using a five-grade visual clarity scoring system during different surgical stages. Secondary outcomes will include irrigation fluid volume, operative time, and frequency of irrigation pressure adjustments. Safety outcomes will include perioperative complications and laboratory assessments.
This study will determine whether intraosseous tranexamic acid can improve visualization of the arthroscopic surgical field and optimize surgical conditions during rotator cuff repair.
Age between 18 and 80 years;
Patients diagnosed with rotator cuff tear by shoulder MRI;
Patients scheduled for arthroscopic rotator cuff repair;
Ability to understand the study and provide written informed consent.
Severe open injury or infection around the surgical area;
Allergy to tranexamic acid;
Previous shoulder surgery;
Coagulation disorders;
Hua Luo
Lead sponsor
Taizhou Hospital
Sponsor institution