Open-Label Study for Shoulder Dislocation Using MG-1 (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

Study Overview

• Status: Completed
• Conditions: Shoulder Dislocation
• Intervention / Treatment: Device: MG-1

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba
    • Funabashi-shi, Chiba, Japan
  • Hyogo
    • Kobe-shi, Hyogo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson K.K. Medical Company
• Investigators: Principal Investigator: Hiroyuki Sugaya, MD, Ph.D, Funabashi Orthopaedic Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 15, 2012
• First Submitted That Met QC Criteria: February 3, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: July 14, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Arthroscopic Bankart repair; Suture anchor; Shoulder dislocation
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: MG-1