Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Dislocation
- Sponsor
- Johnson & Johnson K.K. Medical Company
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Bone Hole Condition
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Clinical Function Evaluation(over 24 months after surgery)