Shoulder Dislocation
Conditions
Keywords
Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation
Brief summary
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Interventions
DEVICEMG-1
Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.
Sponsors
Johnson & Johnson K.K. Medical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgery Success | 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 |
| Clinical Function Evaluation | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | 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 |
| Clinical Function Evaluation | 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) |
| Number of Participants With Abnormal Changes in One or More Laboratory Tests | 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 |
| Adverse Event Evaluation | 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 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MG-1 Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | MG-1 |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 28.2 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment Japan | 24 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 24 |
| serious Total, serious adverse events | 1 / 24 |
Outcome results
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): * 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)
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MG-1 | Clinical Function Evaluation | The JSS-SIS score | 73.7 units on a scale | Standard Deviation 10.3 |
| MG-1 | Clinical Function Evaluation | The Rowe score | 80.4 units on a scale | Standard Deviation 10.7 |
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
Time frame: 12 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MG-1 | Surgery Success | 23 participants |
Secondary
Adverse Event Evaluation
To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery
Time frame: Between the time of obtainment of consent and 24 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MG-1 | Adverse Event Evaluation | 18 participants |
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): * 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)
Time frame: 24 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MG-1 | Clinical Function Evaluation | The JSS-SIS score | 82.7 units on a scale | Standard Deviation 7.9 |
| MG-1 | Clinical Function Evaluation | The Rowe score | 88.9 units on a scale | Standard Deviation 6.7 |
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
Time frame: 12 weeks and 24 weeks after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MG-1 | Number of Participants With Abnormal Changes in One or More Laboratory Tests | 1 participants |
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
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MG-1 | Procedure Success | 23 participants |