Open-Label Study for Shoulder Dislocation Using MG-1 (MG-1)
2014年7月14日 更新者:Johnson & Johnson K.K. Medical Company
Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
研究概览
研究类型
介入性
注册 (实际的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Chiba
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Funabashi-shi、Chiba、日本
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Hyogo
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Kobe-shi、Hyogo、日本
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients with dislocation of the shoulder and indicated for arthroscopic Bankart repair
- Patients of 16 years or older
- Patients who understand the contents of the study and from whom a written consent can be obtained
- Patients who can visit the hospital for follow-ups after surgery
Exclusion Criteria:
- Patients with serious complications
- Patients with comminuted fracture which may prevent fixation of the anchors
Patients with the following diseases or conditions which may delay healing
- Lack of blood, infection, etc.
- Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
- Tissues around the surgical site are not healthy under steroid therapy or chemotherapy
- Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
- Patients with dementia
- Patients with a history of allergy to glycolic acid, poly-L-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane
- Patients who cannot undergo general anesthesia
- Patients who cannot undergo plain X-ray examination or MRI examination
- Patients with previous bone grafting in the shoulder joint
- Patients who participated in another clinical trial within past 3 months
- Patients who are pregnant or lactating. Patients who plan to be pregnant within a year
- Patients judged to be inappropriate for the study by the (sub)investigator
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:MG-1
Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
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Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Surgery Success
大体时间:12 weeks after surgery
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The rate of successful cases when surgery success is defined as "Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment"
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12 weeks after surgery
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Clinical Function Evaluation
大体时间:12 weeks
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To evaluate the Japan Shoulder Society Shoulder Instability Score (JSS-SIS) and Rowe Score at 12 weeks after surgery JSS-SIS Score (subscales are summed, higher values represent a better outcome):
Rowe Score (subscales are summed, higher values represent a better outcome):
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Procedure Success
大体时间:12 weeks
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The rate of successful cases when procedure success was defined as "The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures"
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12 weeks
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Clinical Function Evaluation
大体时间:24 weeks
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To evaluate the JSS-SIS score and Rowe score at 24 weeks after surgery JSS-SIS Score (subscales are summed, higher values represent a better outcome):
Rowe Score (subscales are summed, higher values represent a better outcome):
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24 weeks
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Number of Participants With Abnormal Changes in One or More Laboratory Tests
大体时间:12 weeks and 24 weeks after surgery
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To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development
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12 weeks and 24 weeks after surgery
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Adverse Event Evaluation
大体时间:Between the time of obtainment of consent and 24 weeks after surgery
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To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery
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Between the time of obtainment of consent and 24 weeks after surgery
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Hiroyuki Sugaya, MD, Ph.D、Funabashi Orthopaedic Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年12月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年11月1日
研究注册日期
首次提交
2012年1月15日
首先提交符合 QC 标准的
2012年2月3日
首次发布 (估计)
2012年2月8日
研究记录更新
最后更新发布 (估计)
2014年8月4日
上次提交的符合 QC 标准的更新
2014年7月14日
最后验证
2014年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MG-1的临床试验
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LG Life Sciences完全的
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Galderma R&D完全的健康受试者,男性或女性,年龄在 18-60 岁之间,照片类型为 I、II 或 III,未预处理/预处理皮肤法国