Clinical Trial: Follow-up Study After Bankart Repair Using MG-1

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder

Brief Summary: Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.

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

Current Primary Outcome:

  • Bone Hole Condition [ Time Frame: over 24 months after surgery ]

    To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.

    Definitions of the score are described as below.

    • Type 1: Opened or enlarged
    • Type 2: Slightly closed (<50%)
    • Type 3: Almost closed (>=50%)
    • Type 4: Completely closed
  • Ossification [ Time Frame: over 24 months after surgery ]

    To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.

    Definitions of the score are described as below.

    • Type 1: Little or no ossification
    • Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim
    • Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone
    • Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone


Original Primary Outcome: Same as current

Current Secondary Outcome: Clinical Function Evaluation [ Time Frame: over 24 months after surgery ]

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 Secondary Outcome: Same as current

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

Dates:
Date Received: August 20, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 15, 2015
Last Verified: April 2015