Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair

Summary

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.

Timeline

Start

2026-08-01

Primary completion

2026-11-30

Completion

2026-12-30

Publications

• Results Zhao J, Liang G, Huang H, Hong K, Pan J, Yang W, Liu J, Zeng L. Intravenous Tranexamic Acid Significantly Improved Visualization and Shortened the Operation Time in Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis of Level I and II Studies. Arthroscopy. 2024 Feb;40(2):592-601. doi: 10.1016/j.arthro.2023.06.055. Epub 2023 Jul 7.
• Results Xue X, Zhuang X, Zhou X, Zhu W, Lou J, Yang X, Li N. Tranexamic Acid Reduces Bleeding and Early Pain but Does Not Improve Intraoperative Visualization in Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis. Arthroscopy. 2026 Mar;42(3):669-680. doi: 10.1002/arj.70089. Epub 2026 Mar 19.
• Results Tran SQ, Itthipanichpong T, Limskul D, Thamrongskulsiri N, Tanpowpong T. Intravenous Tranexamic Acid Is Marginally Inferior to Epinephrine Irrigation for Visual Clarity During Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Controlled Trial. Arthroscopy. 2025 Nov;41(11):4460-4468. doi: 10.1016/j.arthro.2025.05.034. Epub 2025 Jun 5.
• Results Shin HJ, You HS, Lee K, Je LG, Kim SG, Yang KS, Jeong WK. Intravenous Tranexamic Acid Improves Visual Clarity During Synovectomy in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Controlled Study. Arthroscopy. 2024 May;40(5):1409-1419. doi: 10.1016/j.arthro.2023.10.019. Epub 2023 Oct 27.

Drugs

Indications