Follow-up Study After Bankart Repair Using MG-1

Completed

• Conditions: Shoulder Dislocation

• Registration Number: NCT02228226
• Lead Sponsor: Johnson & Johnson K.K. Medical Company

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 Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-20
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Primary Completion: 2014-10
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone Hole Condition	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	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 Outcome Measures

Name	Time	Method
Clinical Function Evaluation	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)

Trial Locations

Locations (1)

Funabashi Orthopaedic Hospital; 🇯🇵 Funabashi, Chiba, Japan