Follow-up Study After Bankart Repair Using MG-1

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Dislocation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent Patient who understand the contents of the study and from whom a written consent can be obtained Exclusion Criteria: Patient with dementia Patient who cannot undergo CT examination Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial Patient who is pregnant or lactating Patient judged to be inappropriate for the study by the (sub)investigator

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MG-1treated group<br>MG-1treated group: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Hole Condition | 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 | over 24 months after surgery | 
| Ossification | 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 | over 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | over 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ossification, Suture anchor, Shoulder dislocation, Arthroscopic Bankart repair, Bone hole