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

Primary Purpose

Shoulder Dislocation

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MG-1
Sponsored by
Johnson & Johnson K.K. Medical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dislocation focused on measuring Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MG-1

Arm Description

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

Outcomes

Primary Outcome Measures

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"
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)

Secondary Outcome Measures

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"
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)
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
Adverse Event Evaluation
To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery

Full Information

First Posted
January 15, 2012
Last Updated
July 14, 2014
Sponsor
Johnson & Johnson K.K. Medical Company
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1. Study Identification

Unique Protocol Identification Number
NCT01528319
Brief Title
Open-Label Study for Shoulder Dislocation Using MG-1
Acronym
MG-1
Official Title
Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson K.K. Medical Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MG-1
Arm Type
Experimental
Arm Description
Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Intervention Type
Device
Intervention Name(s)
MG-1
Intervention Description
Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.
Primary Outcome Measure Information:
Title
Surgery Success
Description
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"
Time Frame
12 weeks after surgery
Title
Clinical Function Evaluation
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Procedure Success
Description
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"
Time Frame
12 weeks
Title
Clinical Function Evaluation
Description
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)
Time Frame
24 weeks
Title
Number of Participants With Abnormal Changes in One or More Laboratory Tests
Description
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
Time Frame
12 weeks and 24 weeks after surgery
Title
Adverse Event Evaluation
Description
To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery
Time Frame
Between the time of obtainment of consent and 24 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroyuki Sugaya, MD, Ph.D
Organizational Affiliation
Funabashi Orthopaedic Hospital
Official's Role
Principal Investigator
Facility Information:
City
Funabashi-shi
State/Province
Chiba
Country
Japan
City
Kobe-shi
State/Province
Hyogo
Country
Japan

12. IPD Sharing Statement

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Open-Label Study for Shoulder Dislocation Using MG-1

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