Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Dislocation
- Sponsor
- Johnson & Johnson K.K. Medical Company
- Enrollment
- 24
- Primary Endpoint
- Surgery Success
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
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"
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
- Procedure Success(12 weeks)
- Number of Participants With Abnormal Changes in One or More Laboratory Tests(12 weeks and 24 weeks after surgery)
- Clinical Function Evaluation(24 weeks)
- Adverse Event Evaluation(Between the time of obtainment of consent and 24 weeks after surgery)