Open-Label Study for Shoulder Dislocation Using MG-1

Johnson & Johnson (J&J)

Status

Completed

Conditions

Shoulder Dislocation

Treatments

Device: MG-1

Study type

Interventional

Funder types

Industry

Identifiers

MG-1

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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