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OpenTrials
Completed

NCT Number: NCT01528319

Open-Label Study for Shoulder Dislocation Using MG-1

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

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Key information

Conditions

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

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Funabashi-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Lack of blood, infection, etc.
  • Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
  • 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

Treatment and study plan

MG-1

Device

Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.

Primary outcomes

  1. Surgery Success

    Time frame: 12 weeks after surgery

    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"

  2. Clinical Function Evaluation

    Time frame: 12 weeks

    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 outcomes

  1. Procedure Success

    Time frame: 12 weeks

    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"

  2. Clinical Function Evaluation

    Time frame: 24 weeks

    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)

  3. Number of Participants With Abnormal Changes in One or More Laboratory Tests

    Time frame: 12 weeks and 24 weeks after surgery

    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

  4. Adverse Event Evaluation

    Time frame: Between the time of obtainment of consent and 24 weeks after surgery

    To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery

Sponsors and collaborators

Lead sponsor

Johnson & Johnson K.K. Medical Company

Industry

Registry information

Official study title

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

Acronym: MG-1

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 8, 2012
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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