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NCT Number: NCT07714473

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

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.

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Key information

Conditions

Rotator Cuff Tear Repair

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Arthroscopic Visual Clarity Score

    Time frame: During arthroscopic rotator cuff repair surgery

    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

Secondary outcomes

  1. Irrigation Fluid Volume

    Time frame: During surgery

    Total volume of irrigation fluid (mL) used during arthroscopic rotator cuff repair.

  2. Operative Time

    Time frame: During surgery

    Duration of arthroscopic rotator cuff repair procedure. (Min)

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Luo

CONTACT

[email protected]

0576-85190460

Sponsors and collaborators

Lead sponsor

Hua Luo

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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