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临床试验/KCT0001974
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

Seoul National University Bundang Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新:
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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