Anterior Shoulder Instability
Conditions
Keywords
tranexamic acid, anterior shoulder instability, latarjet, hematoma
Brief summary
The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure. The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.
Interventions
DRUGTranexamic Acid
1g Tranexamic acid prior to skin incision
DRUGSaline
Equivalent volume of saline prior to skin incision
Sponsors
Sports Surgery Clinic, Santry, Dublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded randomized
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Anterior shoulder instability, warranting the Latarjet procedure
Exclusion criteria
* Patients with known risk factors for hyper-coagulable state * Patients under 16 * Patients unable to give consent to partake in the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Postoperative day-1 | — |
| Hematoma Formation | Postoperative day-1 | Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4) |
| Visual Analogue Scale | Postoperative day-1 | — |
| Total Drain output | Postoperative day-1 | The total drain output of blood post-operatively |
Secondary
| Measure | Time frame |
|---|---|
| Wound complications | Postoperative week-2 |
| Haematoma Formation | Postoperative week-2 |
| Total complications | Postoperative month-4 |
Countries
Ireland
Outcome results
None listed