KCT0001974已完成未知
Research for Comparison of anti-adhesion effect and safety of Mediclore(CPCG500) using for anti-adhesive effect after rotator cuff repair: Prospective multicenter randomized double-blinded investigator initiated Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)(—)
- 性别
- All
入选标准
- •Subjects should be suitable consistent with all of these criteria.
- •1) Age>= 20, age=<80
- •2) Patient who underwent intraoperative conversion to complete tear from High grade partial thickness rotator cuff tear
- •3) Small(<1cm) to medium(3cm) size tear of rotator cuff
- •4) Patient who agree to participate this clinical trial voluntarily with wirtten consent
排除标准
- •Anyone who is consistent with one of these criteria cannot participate this trial.
- •1)Patient who have factors that can influence on results of trials
- •(1) Shoulder arthritis.
- •(2) Large to massive cuff tear(>3cm)
- •(3) Past History of rotator cuff tear surgery(revision cases)
- •(4) Rheumatoid arhtritis or other connective tissue disease
- •(5) Isolated subscapularis tendon
- •(6) Repair of subscapularis tendon
- •(7) Symptomatic acromioclavicular joint arthritis
- •(8) Severe adhesive capsulitis
- •(9) Preoperative shoulder stiffness (foward flexion 120 degrees, external rotation 30 degrees, Internal rotation at back 3rd lumbar level, two or more of these)
- •2)Patients who have chronic disease that can influence on surgery, like Uncontrolled diabetes mellitus,hypertension, etc.
- •3)Complex regional pain syndrome patient
- •4)Patients who are expected to have adverse event in surgery
- •(1)Patients who are on, or need anticoagulant medication.
- •(2)Patients who have restriction of anticoagulant or antiplatelet agent.
- •(3)Patients who have liver fuction disorder or renal function insufficiency
- •(4)Patients who have severe systematic disease like severe anemia, etc.
- •(5)Known HIV patient on medication
- •5)Female who is pregnant, may be pregnant, is lactating, or have no will to contracept during these clincial trials.
- •6)Patients who have history of participation of other clnical trials that need administration of medication or medical device within 4 weeks before participation of this clinical trial.
- •7)Other patients who are judged to be inappropriate to this study by investigator.
研究者
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