Google Maps

NCT07714473

Overview

NCT ID: NCT07714473
Lead Sponsor: Hua LuoOTHER
Official Title: Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Nov 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 60Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Contacts and Locations

Central Contacts: Hua LuoContact
luohua66ry@163.com0576-85190460

Similar Studies

Participant Group/Arms

Intraosseous Tranexamic Acid GroupExperimental

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 GroupPlacebo 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