Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Bone Hole Condition
研究概览
简要总结
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent
- •Patient who understand the contents of the study and from whom a written consent can be obtained
排除标准
- •Patient with dementia
- •Patient who cannot undergo CT examination
- •Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial
- •Patient who is pregnant or lactating
- •Patient judged to be inappropriate for the study by the (sub)investigator
结局指标
主要结局
Bone Hole Condition
时间窗: over 24 months after surgery
To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Opened or enlarged * Type 2: Slightly closed (\<50%) * Type 3: Almost closed (\>=50%) * Type 4: Completely closed
Ossification
时间窗: over 24 months after surgery
To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Little or no ossification * Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim * Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone * Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone
次要结局
- Clinical Function Evaluation(over 24 months after surgery)