Open-Label Study for Shoulder Dislocation Using MG-1

NCT01528319 | Completed Results

• 1 other identifier: MG-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Shoulder Dislocation

Keywords

Arthroscopic Bankart repair; Suture anchor; Shoulder dislocation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Procedure Success

  12 weeks

• Clinical Function Evaluation

  24 weeks

• Number of Participants With Abnormal Changes in One or More Laboratory Tests

  12 weeks and 24 weeks after surgery

• Adverse Event Evaluation

  Between the time of obtainment of consent and 24 weeks after surgery

Study Arms (1)

MG-1

EXPERIMENTAL

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

Device: MG-1

Interventions

MG-1 DEVICE

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

MG-1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson K.K. Medical Company: lead

Study Sites (2)

Unknown Facility

Funabashi-shi, Chiba, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Results Point of Contact

• Title: Department Chief, Clinical Development & PMS
• Organization: Johnson & Johnson K.K. Medical Company

yikeda5@its.jnj.com

+81-3-4411-6789

Study Officials

• Hiroyuki Sugaya, MD, Ph.D

  Funabashi Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: February 8, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: August 4, 2014
• Results First Posted: August 4, 2014

Record last verified: 2014-07

Locations

JP (2)