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Follow-up Study After Bankart Repair Using MG-1

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ClinicalTrials.gov Identifier: NCT02228226
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Shoulder Dislocation

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228226


Locations
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Japan
Funabashi Orthopaedic Hospital
Funabashi, Chiba, Japan
Sponsors and Collaborators
Johnson & Johnson K.K. Medical Company
Investigators
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Principal Investigator: Hiroyuki Sugaya, MD, Ph. D Funabashi Orthopaedic Hospital

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Responsible Party: Johnson & Johnson K.K. Medical Company
ClinicalTrials.gov Identifier: NCT02228226     History of Changes
Other Study ID Numbers: JJKK-MIT-002
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Johnson & Johnson K.K. Medical Company:
Arthroscopic Bankart repair
Bone hole
Ossification
Suture anchor
Shoulder dislocation
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries