Arthroscopic Rotator Cuff Repair Performed With Intraarticular Tranexamic Acid Could it Provide Improved Visual Clarity and Less Post-operative Pain? A Prospective, Double Blind, Randomized Study of 64 Patients.

NCT05453266 | Completed DMC

• 1 other identifier: 13.02.2020/009
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Shoulder arthroscopy is widely used for treatment of different shoulder pathologies. Visual clarity is essential for successful and safe surgery. The aim of present study is to determine whether intraarticular use of tranexamic acid (TXA) in surgery fluid can improve visual clarity and early postoperative pain.

Conditions

Rotator Cuff Tears; Rotator Cuff Rupture; Tranexamic Acid; Shoulder Arthroscopy; Visual Clarity

Keywords

Rotator cuff tear; Rotator cuff rupture; Tranexamic acid; Shoulder arthroscopy; Visual clarity

Outcome Measures

Primary Outcomes (1)

• Arthroscopic Visual Clarity

  Effect of TXA in arthroscopic irrigation solution to Arthroscopic Visual Clarity

  Intra-operatively

Secondary Outcomes (1)

• Post-operative Pain Evaluation

  Up to the 2nd post-operative day

Study Arms (2)

TXA Group

ACTIVE COMPARATOR

Patients with rotator cuff tear, operated arthroscopically under intraarticularly applied tranexamic acid in arthroscopic irrigation solution.

Procedure: Application of Tranexamic acid in arthroscopic irrigation solution

Control group

PLACEBO COMPARATOR

Patients with rotator cuff tear, operated arthroscopically without intraarticularly applied tranexamic acid in arthroscopic irrigation solution.

Procedure: No application of Tranexamic acid in arthroscopic irrigation solution

Interventions

Application of Tranexamic acid in arthroscopic irrigation solution PROCEDURE

Application of Tranexamic acid in arthroscopic irrigation solution

TXA Group

No application of Tranexamic acid in arthroscopic irrigation solution PROCEDURE

No application of Tranexamic acid in arthroscopic irrigation solution

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• being older than 18 years of age,
• having an MRI confirmed rotator cuff rupture with a history of failure of conservative treatment of at least 6 months,
• being willing to participate to the clinical trial.

You may not qualify if:

• patients with a history of coagulopathy, deep venous thrombosis, tendency to thrombotic events,
• patients under anti-coagulant therapy,
• patients with inferior vena cava filter,
• patients with abnormal prothrombin time-activated partial thromboplastin time-bleeding time,
• patients with a history of cardiac/renal/hepatic disease,
• patients with a diagnosis of TXA allergy,
• patients with an acute RCT, having been treated conservatively for less than 6 months,
• being under the age of 18

Sponsors & Collaborators

• Florence Nightingale Hospital, Istanbul: lead

Study Sites (1)

Ataşehir Florence Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 12, 2022
• Study Start: January 1, 2022
• Primary Completion: June 5, 2022
• Study Completion: June 10, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)