Open-Label Study for Shoulder Dislocation Using MG-1

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

Official Title
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Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Device: MG-1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MG-1<br>Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 | Device: MG-1<br>* Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | Between the time of obtainment of consent and 24 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation