Follow-up Study After Bankart Repair Using MG-1

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT02228226
• Date of registration: 20/08/2014
• Prospective Registration: No
• Primary sponsor: Johnson & Johnson K.K. Medical Company
• Public title: Follow-up Study After Bankart Repair Using MG-1
• Scientific title: Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
• Date of first enrolment: August 2014
• Target sample size: 11
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02228226
• Study type: Observational
• Study design: Observational Model: Case-Only, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Hiroyuki Sugaya, MD, Ph. D
• Affiliation: Funabashi Orthopaedic Hospital

Key inclusion & exclusion 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



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Shoulder Dislocation

Primary Outcome(s)

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

Ossification [Time Frame: over 24 months after surgery]

Secondary Outcome(s)

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

Secondary ID(s)

JJKK-MIT-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors