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
相似试验
已完成
不适用
Combination Therapy With Atelocollagen in Epidural Nerve BlockDegenerative Lumbar Spine DiseaseNCT05014945Gangnam Severance Hospital20
终止
不适用
Effect of Atelocollagen injection in subjects with Arthroscopic Rotator Cuff Repair: a single center, open, randomized, observational studyDiseases of the musculo-skeletal system and connective tissueKCT0004195The Catholic University of Korea, Seoul St. Mary's Hospital78
招募中
4 期
Effect of Atelocollagen Injection in Patients With Calcific TendinitisCalcific Tendinitis of ShoulderAtelocollagenNCT06040112Hyungsuk Kim46
尚未招募
Unknown
Effect of atelocollagen injection in patients with calcific tendinitisDiseases of the musculoskeletal system and connective tissueKCT0008833The Catholic University of Korea, Eunpyeong St. Mary's Hospital42
已完成
3 期
An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial FoldsNasolabial FoldsNCT01060943Sewon Cellontech Co., Ltd.73
