Open-Label Study for Shoulder Dislocation Using MG-1

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson K.K. Medical Company
ClinicalTrials.gov Identifier:
NCT01528319
First received: January 15, 2012
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate effectiveness and safety of MG-1 to use arthroscopic Bankart repair for glenohumeral instability.


Condition Intervention
Shoulder Dislocation
Device: MG-1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study for Shoulder Dislocation Using MG-1

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson K.K. Medical Company:

Primary Outcome Measures:
  • Operation-Success [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Technical success confirmed at the end of surgery and no dislodge/broken anchor nor ruptured sutures observed at 12 weeks post operative evaluation. MRI results will be evaluated by an independent evaluation committee.

  • Clinical Function [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    JSS-SIS (Japan Shoulder Society Shoulder Instability Score) and Rowe score at 12 weeks after surgery will be observed. Both scores will be evaluated by other surgeon who did not operate the surgery.


Secondary Outcome Measures:
  • Procedure success [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Insertion of anchor in Fossa articularis without breaking and suture without pulling off from the tissue during surgery.

  • Clinical Function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    JSS-SIS and Rowe score at 24 weeks after surgery will be observed.

  • Laboratory Test evaluation [ Time Frame: 12 weeks and 24 weeks ] [ Designated as safety issue: Yes ]
    Abnormal laboratory test data considered to be related to the study device or procedure at 12 weeks and 24 weeks.

  • Adverse Events [ Time Frame: From day of IC to 24 weeks ] [ Designated as safety issue: Yes ]
    Adverse events observed by 24 weeks after surgery.


Enrollment: 24
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MG-1
Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Device: MG-1
Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having glenohumeral instability which is indication for the arthroscopic Bankart repair;
  • Adults over 16 years of age;
  • Being able to comprehend, sign, and date the written informed consent form (ICF); and
  • Being able to visit hospital to be examined the repaired region after the procedure.

Exclusion Criteria:

  • Having serious concomitant disease;
  • Having a comminuted fracture which make it difficult for anker to be fixed in bone;
  • In the following status or having disease which causes delay of hearing at the surgical site;

    1. lack of blood circulation or transmitted disease
    2. mental disorders, addicted to alcohol and/or drug
    3. taking steroid therapy/chemotherapy and tissues at surgical site are unhealthy
  • Having epilepsia or bone disease (such as cystic change and osteopenia);
  • Demented;
  • Having allergy or unable to tolerate glycolic acid, poly-L-lactic acid, β-tricalcium Phosphate, Polyethylene and/or Polydioxanone;
  • Impossibility to perform general anesthesia;
  • Inoperativeness for Plain x-ray examination or MRI exam;
  • History of bone grafting in the shoulder joint;
  • Participation in a clinical trial within the past 3 months;
  • Pregnant of nursing female or female whose pregnancy is expected within 1 year;
  • A principal investigator or a co-principal investigator determines that patient is unsuitable for this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528319

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

No publications provided

Responsible Party: Johnson & Johnson K.K. Medical Company
ClinicalTrials.gov Identifier: NCT01528319     History of Changes
Other Study ID Numbers: MG-1
Study First Received: January 15, 2012
Last Updated: July 3, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Johnson & Johnson K.K. Medical Company:
Arthroscopic Bankart repair
Suture anchor
Shoulder dislocation

Additional relevant MeSH terms:
Dislocations
Shoulder Dislocation
Wounds and Injuries
Arm Injuries

ClinicalTrials.gov processed this record on July 26, 2014