Rotator Cuff Tear Repair
Conditions
Brief summary
This prospective randomized controlled trial aims to evaluate the efficacy and safety of intraosseous tranexamic acid administration during arthroscopic rotator cuff repair. Eligible patients undergoing arthroscopic rotator cuff repair will be randomly assigned in a 1:1 ratio to receive either intraosseous tranexamic acid or intraosseous normal saline placebo. Tranexamic acid will be administered at a dose of 15 mg/kg through intraosseous injection into the proximal humerus after anesthesia induction. The primary outcome will be intraoperative arthroscopic visual clarity assessed using a five-grade visual clarity scoring system during different surgical stages. Secondary outcomes will include irrigation fluid volume, operative time, and frequency of irrigation pressure adjustments. Safety outcomes will include perioperative complications and laboratory assessments. This study will determine whether intraosseous tranexamic acid can improve visualization of the arthroscopic surgical field and optimize surgical conditions during rotator cuff repair.
Interventions
DRUGTranexamic Acid
Tranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.
DRUGNormal Saline
Participants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.
Sponsors
Hua Luo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 80 years; * Patients diagnosed with rotator cuff tear by shoulder MRI; * Patients scheduled for arthroscopic rotator cuff repair; * Ability to understand the study and provide written informed consent.
Exclusion criteria
* Severe open injury or infection around the surgical area; * Allergy to tranexamic acid; * Previous shoulder surgery; * Coagulation disorders; * Current anticoagulant therapy that cannot be discontinued; * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Arthroscopic Visual Clarity Score | During arthroscopic rotator cuff repair surgery | Intraoperative arthroscopic visual clarity will be assessed during different surgical stages, including glenohumeral joint debridement, acromioplasty, and rotator cuff repair. A five-grade visual clarity scoring system will be used: Grade 1: Extremely poor visualization due to severe active bleeding. The surgical field cannot be adequately visualized and the procedure cannot proceed normally. Grade 2: Poor visualization with substantial bleeding interference. Surgical manipulation is significantly affected and additional hemostatic procedures are required. Grade 3: Moderate visualization. Mild to moderate bleeding is present and partially interferes with visualization, but surgery can proceed after routine management. Grade 4: Good visualization. Only minimal bleeding points are present, with limited interference and no requirement for additional hemostatic intervention. Grade 5: Excellent visualization. The surgical field is clear with no visible bleeding points and optimal visua |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Irrigation Fluid Volume | During surgery | Total volume of irrigation fluid (mL) used during arthroscopic rotator cuff repair. |
| Operative Time | During surgery | Duration of arthroscopic rotator cuff repair procedure. (Min) |
Countries
China
Contacts
CONTACTHua Luo
Outcome results
None listed