Open-Label Study for Shoulder Dislocation Using MG-1

NCT ID: NCT01528319

Last Updated: 2014-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-11-30

Brief Summary

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

Conditions

Shoulder Dislocation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MG-1

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

Group Type: EXPERIMENTAL

MG-1

Intervention Type: DEVICE

Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.

Interventions

MG-1

Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson K.K. Medical Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroyuki Sugaya, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Funabashi Orthopaedic Hospital

Locations

Funabashi-shi, Chiba, Japan

Kobe, Hyōgo, Japan

Countries

Japan

Other Identifiers

MG-1

Identifier Type: -

Identifier Source: org_study_id