Follow-up Study After Bankart Repair Using MG-1

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228226
• Other study ID #: JJKK-MIT-002
• Status: Completed
• Phase: N/A
• First received: August 20, 2014
• Last updated: April 15, 2015
• Start date: August 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Johnson & Johnson K.K. Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dislocations
• Shoulder Dislocation

Locations

Country	Name	City	State
Japan	Funabashi Orthopaedic Hospital	Funabashi	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson K.K. Medical Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No