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

July 15, 2026 updated by: Hua Luo

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Linhai, Zhejiang, China
        • No. 150 Ximen Road
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraosseous Tranexamic Acid Group
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
Tranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.
Placebo Comparator: Placebo Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During arthroscopic rotator cuff repair surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irrigation Fluid Volume
Time Frame: During surgery
Total volume of irrigation fluid (mL) used during arthroscopic rotator cuff repair.
During surgery
Operative Time
Time Frame: During surgery
Duration of arthroscopic rotator cuff repair procedure. (Min)
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Luo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K20260564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because no public data sharing plan has been established for this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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