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

NCT07714473 | Not Yet Recruiting

• 1 other identifier: K20260564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rotator Cuff Tear Repair

Outcome Measures

Primary Outcomes (1)

• Arthroscopic Visual Clarity Score

  Intraoperative arthroscopic visual clarity will be assessed during different surgical stages, including glenohumeral joint debridement, acromioplasty, and rotator cuff repair. A five-grade visual clarity scoring system will be used: Grade 1: Extremely poor visualization due to severe active bleeding. The surgical field cannot be adequately visualized and the procedure cannot proceed normally. Grade 2: Poor visualization with substantial bleeding interference. Surgical manipulation is significantly affected and additional hemostatic procedures are required. Grade 3: Moderate visualization. Mild to moderate bleeding is present and partially interferes with visualization, but surgery can proceed after routine management. Grade 4: Good visualization. Only minimal bleeding points are present, with limited interference and no requirement for additional hemostatic intervention. Grade 5: Excellent visualization. The surgical field is clear with no visible bleeding points and optimal visua

  During arthroscopic rotator cuff repair surgery

Secondary Outcomes (2)

• Irrigation Fluid Volume

  During surgery

• Operative Time

  During surgery

Study Arms (2)

Intraosseous Tranexamic Acid Group

EXPERIMENTAL

Participants receive intraosseous tranexamic acid administration at a dose of 15 mg/kg into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.

Drug: Tranexamic Acid

Placebo Control Group

PLACEBO COMPARATOR

Participants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.

Drug: Normal Saline

Interventions

Tranexamic Acid DRUG

Tranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.

Intraosseous Tranexamic Acid Group

Normal Saline DRUG

Participants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.

Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe open injury or infection around the surgical area;
• Allergy to tranexamic acid;
• Previous shoulder surgery;
• Coagulation disorders;
• Current anticoagulant therapy that cannot be discontinued;
• Pregnancy.

Sponsors & Collaborators

• Hua Luo: lead

Study Sites (1)

No. 150 Ximen Road

Linhai, Zhejiang, China

Location

Related Publications (4)

• 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.

  PMID: 37423470 RESULT

• 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.

  PMID: 41856504 RESULT

• 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.

  PMID: 40482981 RESULT

• 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.

  PMID: 37890542 RESULT

MeSH Terms

Interventions

Tranexamic Acid; Saline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Hua Luo

CONTACT

0576-85190460; luohua66ry@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)