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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01528319
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : August 4, 2014
Last Update Posted : August 4, 2014
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson K.K. Medical Company

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

Condition or disease Intervention/treatment
Shoulder Dislocation Device: MG-1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
Study Start Date : December 2011
Primary Completion Date : August 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Surgery Success [ Time Frame: 12 weeks after surgery ]
    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"

  2. Clinical Function Evaluation [ Time Frame: 12 weeks ]

    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 :
  1. Procedure Success [ Time Frame: 12 weeks ]
    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"

  2. Clinical Function Evaluation [ Time Frame: 24 weeks ]

    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)

  3. Number of Participants With Abnormal Changes in One or More Laboratory Tests [ Time Frame: 12 weeks and 24 weeks after surgery ]
    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

  4. Adverse Event Evaluation [ Time Frame: Between the time of obtainment of consent and 24 weeks after surgery ]
    To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528319


Locations
Japan
Funabashi-shi, Chiba, Japan
Kobe-shi, Hyogo, Japan
Sponsors and Collaborators
Johnson & Johnson K.K. Medical Company
Investigators
Principal Investigator: Hiroyuki Sugaya, MD, Ph.D Funabashi Orthopaedic Hospital

Responsible Party: Johnson & Johnson K.K. Medical Company
ClinicalTrials.gov Identifier: NCT01528319     History of Changes
Other Study ID Numbers: MG-1
First Posted: February 8, 2012    Key Record Dates
Results First Posted: August 4, 2014
Last Update Posted: August 4, 2014
Last Verified: July 2014

Keywords provided by Johnson & Johnson K.K. Medical Company:
Arthroscopic Bankart repair
Suture anchor
Shoulder dislocation

Additional relevant MeSH terms:
Joint Dislocations
Shoulder Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries