Open-Label Study for Shoulder Dislocation Using MG-1

Not Applicable

Completed

Brief Summary: To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder

Recruitment & Eligibility

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
1. Lack of blood, infection, etc.
2. Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
3. 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

Arm && Interventions

Group	Intervention	Description
MG-1	MG-1	Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1

Primary Outcome Measures

Name	Time	Method
Surgery Success	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	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)

Secondary Outcome Measures

Name	Time	Method
Procedure Success	12 weeks	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"
Number of Participants With Abnormal Changes in One or More Laboratory Tests	12 weeks and 24 weeks after surgery	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
Clinical Function Evaluation	24 weeks	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)
Adverse Event Evaluation	Between the time of obtainment of consent and 24 weeks after surgery	To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery