To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.
Unnamed facility
Funabashi-shi, Chiba, Japan
Unnamed facility
Kobe, Hyōgo, Japan
Surgery Success
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"
Time frame: 12 weeks after surgery
Clinical Function Evaluation
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)
Time frame: 12 weeks
Procedure Success
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"
Time frame: 12 weeks
Clinical Function Evaluation
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): * 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)
Time frame: 24 weeks
Number of Participants With Abnormal Changes in One or More Laboratory Tests
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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Time frame: 12 weeks and 24 weeks after surgery
Adverse Event Evaluation
To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery
Time frame: Between the time of obtainment of consent and 24 weeks after surgery