Follow-up Study After Bankart Repair Using MG-1

NCT02228226 | Completed

• 1 other identifier: JJKK-MIT-002
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Keywords

Arthroscopic Bankart repair; Bone hole; Ossification; Suture anchor; Shoulder dislocation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical Function Evaluation

  over 24 months after surgery

Study Arms (1)

MG-1treated group

MG-1treated group: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson K.K. Medical Company: lead

Study Sites (1)

Funabashi Orthopaedic Hospital

Funabashi, Chiba, Japan

Location

MeSH Terms

Conditions

Shoulder Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Study Officials

• Hiroyuki Sugaya, MD, Ph. D

  Funabashi Orthopaedic Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2014
• First Posted: August 28, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

JP (1)