CompletedNot Applicable

Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

Turkey (Türkiye)80 participantsStarted 2021-05-01

Plain-language summary

This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-70 years * MRI-confirmed full-thickness rotator cuff tear * Planned primary arthroscopic rotator cuff repair * Written informed consent obtained Exclusion Criteria: * Age \>70 years * Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease) * Significant renal impairment * History of thromboembolic disease * Contraindication to tranexamic acid * Irreparable massive tear with advanced fatty degeneration or severe muscle atrophy * Revision surgery * Planned concomitant open surgery

What they're measuring

Surgical field visibility

Timeframe: Intraoperative (during arthroscopic rotator cuff repair)

Trial details

NCT IDNCT07442643

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Rotator Cuff Tear trials