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 14, 2014
Last verified: July 2014
  Purpose

To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder


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 Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Surgery Success [ Time Frame: 12 weeks after surgery ] [ Designated as safety issue: No ]
    The rate of successful cases when surgery success is defined as "Procedure success is confirmed, the anchors are confirmed to be in the burr holes by the MRI examination, the glenohumeral ligament labral complex is maintained at the anterior edge of the glenoid cavity at 12 weeks after surgery, and there is no need of retreatment"

  • Clinical Function Evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • Procedure Success [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The rate of successful cases when procedure success was defined as "The anchors can be inserted into the burr holes without breakage and the glenohumeral ligament labral complex can be sutured without tear of the sutures"

  • Clinical Function Evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    To evaluate the JSS-SIS score and Rowe score at 24 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)

  • Number of Participants With Abnormal Changes in One or More Laboratory Tests [ Time Frame: 12 weeks and 24 weeks after surgery ] [ Designated as safety issue: Yes ]
    To evaluate changes over time in each laboratory test item from before surgery to 12 and 24 weeks after surgery regarding the presence or absence of abnormal changes, causal relationship with this product and causes for development

  • Adverse Event Evaluation [ Time Frame: Between the time of obtainment of consent and 24 weeks after surgery ] [ Designated as safety issue: Yes ]
    To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery


Enrollment: 24
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: August 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:

  • Patients with dislocation of the shoulder and indicated for arthroscopic Bankart repair
  • Patients of 16 years or older
  • Patients who understand the contents of the study and from whom a written consent can be obtained
  • Patients who can visit the hospital for follow-ups after surgery

Exclusion Criteria:

  • Patients with serious complications
  • Patients with comminuted fracture which may prevent fixation of the anchors
  • Patients with the following diseases or conditions which may delay healing

    1. Lack of blood, infection, etc.
    2. Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
    3. Tissues around the surgical site are not healthy under steroid therapy or chemotherapy
  • Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
  • Patients with dementia
  • Patients with a history of allergy to glycolic acid, poly-L-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane
  • Patients who cannot undergo general anesthesia
  • Patients who cannot undergo plain X-ray examination or MRI examination
  • Patients with previous bone grafting in the shoulder joint
  • Patients who participated in another clinical trial within past 3 months
  • Patients who are pregnant or lactating. Patients who plan to be pregnant within a year
  • Patients judged to be inappropriate for the study by the (sub)investigator
  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

Locations
Japan
Funabashi-shi, Chiba, Japan
Kobe-shi, Hyogo, Japan
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
Results First Received: January 26, 2014
Last Updated: July 14, 2014
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
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014