Rotator Cuff Tears
Conditions
Keywords
rotator cuff repair, tranexamic acid, visual clarity, shoulder arthroscopy, intra-articular administration
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.
Interventions
DRUGTranexamic acid (intra-articular)
500 mg of tranexamic acid added per 1 L of normal-saline irrigation fluid.
1000 mg of tranexamic acid administered intravenously 10 minutes before surgery.
Sponsors
Konkuk University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative visual clarity | Intraoperatively, at the end of each of the six surgical stages | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total operative time | Intraoperative (duration of surgery) | Total duration of the surgical procedure. |
| Estimated blood loss | From immediately before surgery to immediately after the end of surgery | Estimated blood loss calculated from serum hemoglobin measured before and after surgery using the formula described by Good et al. |
| Irrigation-fluid volume | Intraoperatively, from skin incision to skin closure (duration of surgery) | Total volume of irrigation fluid used during the procedure. |
| Number of irrigation-pressure increases | Intraoperatively, from skin incision to skin closure (duration of surgery) | Number of times the irrigation pump pressure was increased to control bleeding affecting the surgical field |
| Postoperative shoulder swelling | Baseline (pre-operative) and postoperative day 1 | Shoulder circumference and diameter measured at the axillary and deltoid sites with the arm abducted \~30 degrees, compared between pre-operative and postoperative day 1 |
| Postoperative pain | Pain assessed using the Visual Analog Scale (VAS) for pain, ranging from 0 (no pain) to 10 (worst imaginable pain); higher scores indicate worse outcome, on postoperative day 1 | Pain assessed using a visual analog scale (VAS) on postoperative day 1 |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeok Won Chung, MD
Konkuk University Medical Center
Outcome results
None listed