Open-Label Study for Shoulder Dislocation Using MG-1

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

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

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