The Effect of Intravenous Versus Intra-articular Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Prospective, Randomized, Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Intraoperative visual clarity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Intraoperative visual clarity
时间窗: 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.
次要结局
- Estimated blood loss(From immediately before surgery to immediately after the end of surgery)
- Total operative time(Intraoperative (duration of surgery))
- Irrigation-fluid volume(Intraoperatively, from skin incision to skin closure (duration of surgery))
- Number of irrigation-pressure increases(Intraoperatively, from skin incision to skin closure (duration of surgery))
- Postoperative shoulder swelling(Baseline (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)