Follow-up Study After Bankart Repair Using MG-1

April 15, 2015 updated by: Johnson & Johnson K.K. Medical Company

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Funabashi, Chiba, Japan
        • Funabashi Orthopaedic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
over 24 months after surgery
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
over 24 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Function Evaluation
Time Frame: 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)
over 24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson K.K. Medical Company

Investigators

  • Principal Investigator: Hiroyuki Sugaya, MD, Ph. D, Funabashi Orthopaedic Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 26, 2014

First Posted (Estimate)

August 28, 2014

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJKK-MIT-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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