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临床试验/KCT0005184
KCT0005184已完成未知

Effect of patch type atelocollagen in subjects with arthroscopic rotator cuff repair

The Catholic University of Korea, Eunpyeong St. Mary's Hospital0 个研究点目标入组 55 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
发起方
入组人数
55

研究概览

简要总结

The clinical trial data collection was completed on December 29, 2022, after the final one-year follow-up of the last patient, with 26 participants in the control group (4 dropouts) and 29 in the experimental group (2 dropouts). Adverse Events: 0 cases Primary Endpoint: In the experimental group, there were 3 cases (Sugaya type IV in 2 cases, type V in 1 case), compared to 9 cases in the control group (Sugaya type IV in 7 cases, type V in 2 cases), showing a significantly lower rate of re-tear in the experimental group (p=0.048). Secondary Endpoint: There were no significant differences between the two groups in terms of range of joint motion and functional scores.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
30(Year) 至 69(Year)(—)
性别
All

入选标准

  • ?adult between 30 to 69 years old
  • ?arthroscopic rotator cuff repair
  • ?case confirming the medication for at least 1 week and agrreeing to maintaining the doses steady during the study
  • ?case agreed the participation of this study and consent by him-/herself

排除标准

  • ?having the past hostory of infectious arthritis, rheumatoid arthritis, tumor, fracture
  • ?hypersensitivity
  • ?having a history of anaphylaxis
  • ?case or their family faving an autoimmune disease or past history
  • ?hypersensitive to the graft
  • ?hypersensirive to a pig protein
  • ?phychological problems that a researcher judged as inappropriate
  • ?undertook an intraarticular injection of steroid or others before one month prior to the surgery
  • ?having medication including oral steroids

研究者

发起方
The Catholic University of Korea, Eunpyeong St. Mary's Hospital

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