Clinical Trial: Open-Label Study for Shoulder Dislocation Using MG-1

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder

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

Detailed Summary:
Sponsor: Johnson & Johnson K.K. Medical Company

Current Primary Outcome:

  • 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"
  • 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)


Original Primary Outcome:

  • Operation-Success [ Time Frame: 12 weeks ]
    Technical success confirmed at the end of surgery and no dislodge/broken anchor nor ruptured sutures observed at 12 weeks post operative evaluation. MRI results will be evaluated by an independent evaluation committee.
  • Clinical Function [ Time Frame: 12 weeks ]
    JSS-SIS (Japan Shoulder Society Shoulder Instability Score) and Rowe score at 12 weeks after surgery will be observed. Both scores will be evaluated by other surgeon who did not operate the surgery.


Current Secondary Outcome:

  • 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"
  • 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)
  • 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
  • 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


Original Secondary Outcome:

  • Procedure Success [ Time Frame: 12 weeks ]
    Insertion of anchor in Fossa articularis without breaking and suture without pulling off from the tissue during surgery.
  • Clinical Function [ Time Frame: 24 weeks ]
    JSS-SIS and Rowe score at 24 weeks after surgery will be observed.
  • Laboratory Test evaluation [ Time Frame: 12 weeks and 24 weeks ]
    Abnormal laboratory test data considered to be related to the study device or procedure at 12 weeks and 24 weeks.
  • Adverse Events [ Time Frame: From day of IC to 24 weeks ]
    Adverse events observed by 24 weeks after surgery.


Information By: Johnson & Johnson K.K. Medical Company

Dates:
Date Received: January 15, 2012
Date Started: December 2011
Date Completion:
Last Updated: July 14, 2014
Last Verified: July 2014