Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Surgery Success
研究概览
简要总结
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •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
排除标准
- •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
结局指标
主要结局
Surgery Success
时间窗: 12 weeks after surgery
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"
Clinical Function Evaluation
时间窗: 12 weeks
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): * Pain (0 to 20) * Function (0 to 20) * Range of Motion (0 to 20) * Evaluation of X-ray findings (0 to 10) * Stability (0 to 30) Rowe Score (subscales are summed, higher values represent a better outcome): * Stability (0 to 50) * Motion (0 to 20) * Function (0 to 30)
次要结局
- Procedure Success(12 weeks)
- Number of Participants With Abnormal Changes in One or More Laboratory Tests(12 weeks and 24 weeks after surgery)
- Clinical Function Evaluation(24 weeks)
- Adverse Event Evaluation(Between the time of obtainment of consent and 24 weeks after surgery)