Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

NCT07686705 | Completed

• 1 other identifier: 2022-12-017
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

Conditions

Rotator Cuff Tears

Keywords

rotator cuff repair; tranexamic acid; visual clarity; shoulder arthroscopy; intra-articular administration

Outcome Measures

Primary Outcomes (1)

• Intraoperative visual clarity

  Surgeon-rated clarity of the arthroscopic surgical field on a 0-10 numeric scale (0 = poorest visualization, 10 = optimal visualization), scored at the end of each of six surgical stages: glenohumeral procedure, subacromial bursectomy, acromioplasty, rotator cuff inspection, medial-row repair, and lateral-row repair.

  Intraoperatively, at the end of each of the six surgical stages

Secondary Outcomes (6)

• Total operative time

  Intraoperative (duration of surgery)

• Estimated blood loss

  From immediately before surgery to immediately after the end of surgery

• Irrigation-fluid volume

  Intraoperatively, from skin incision to skin closure (duration of surgery)

• Number of irrigation-pressure increases

  Intraoperatively, from skin incision to skin closure (duration of surgery)

• Postoperative shoulder swelling

  Baseline (pre-operative) and postoperative day 1

Study Arms (3)

Control

NO INTERVENTION

No tranexamic acid; arthroscopic rotator cuff repair performed with plain normal-saline irrigation.

Intra-articular TXA

EXPERIMENTAL

Tranexamic acid 500 mg added to each 1 L of normal-saline irrigation fluid during arthroscopic rotator cuff repair.

Drug: Tranexamic acid (intra-articular)

Intravenous TXA

EXPERIMENTAL

Tranexamic acid 1000 mg administered intravenously 10 minutes before surgery; plain normal-saline irrigation as in the control group.

Drug: Tranexamic acid (intravenous)

Interventions

Tranexamic acid (intra-articular) DRUG

500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.

Intra-articular TXA

Tranexamic acid (intravenous) DRUG

1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.

Intravenous TXA

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 18-80 years
• Diagnosed with a rotator cuff tear
• Failure of conservative treatment for more than 3 months
• Rotator cuff deemed repairable on magnetic resonance imaging

You may not qualify if:

• Known hypersensitivity to tranexamic acid
• Previous cerebrovascular accident
• Coronary stent or other history of thromboembolic disease
• Anticoagulant therapy
• Uncontrolled hypertension (systolic pressure \> 180 mmHg)
• Abnormal prothrombin time or activated partial thromboplastin time
• Acute traumatic rotator cuff tear
• Irreparable rotator cuff tear

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 05030, South Korea

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Seok Won Chung, MD

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon (outcome assessor) and the patient were blinded to group allocation. Study drug and irrigation fluid were prepared in a separate room by a circulating nurse; only the anesthesia team administering the intravenous agent was aware of allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: July 7, 2026
• Study Start: May 18, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 26, 2023
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)