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To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-1 | Experimental | Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-1 | Device | Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Surgery Success | 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" | 12 weeks after surgery |
| Clinical Function Evaluation | 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):
Rowe Score (subscales are summed, higher values represent a better outcome):
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | 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" | 12 weeks |
| Clinical Function Evaluation |
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Inclusion Criteria:
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Hiroyuki Sugaya, MD, Ph.D | Funabashi Orthopaedic Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Funabashi-shi | Chiba | Japan | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | MG-1 | Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MG-1 | Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Surgery Success | 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" | Posted | Number | participants | 12 weeks after surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MG-1 | Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyogenic arthritis involving shoulder region | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Department Chief, Clinical Development & PMS | Johnson & Johnson K.K. Medical Company | +81-3-4411-6789 | yikeda5@its.jnj.com |
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| ID | Term |
|---|---|
| D012783 | Shoulder Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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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):
Rowe Score (subscales are summed, higher values represent a better outcome):
|
| 24 weeks |
| Number of Participants With Abnormal Changes in One or More Laboratory Tests | 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 | 12 weeks and 24 weeks after surgery |
| Adverse Event Evaluation | To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery | Between the time of obtainment of consent and 24 weeks after surgery |
| Kobe |
| Hyōgo |
| Japan |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Clinical Function Evaluation | 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):
Rowe Score (subscales are summed, higher values represent a better outcome):
| Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
| Secondary | Procedure Success | 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" | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Clinical Function Evaluation | 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):
Rowe Score (subscales are summed, higher values represent a better outcome):
| Posted | Mean | Standard Deviation | units on a scale | 24 weeks |
|
|
|
| Secondary | Number of Participants With Abnormal Changes in One or More Laboratory Tests | 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 | Posted | Number | participants | 12 weeks and 24 weeks after surgery |
|
|
|
| Secondary | Adverse Event Evaluation | To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery | Posted | Number | participants | Between the time of obtainment of consent and 24 weeks after surgery |
|
|
|
| 1 |
| 24 |
| 7 |
| 24 |
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| D000070599 |
| Shoulder Injuries |