Status:
COMPLETED
Open-Label Study for Shoulder Dislocation Using MG-1
Lead Sponsor:
Johnson & Johnson K.K. Medical Company
Conditions:
Shoulder Dislocation
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01528319
Start Date
December 1 2011
End Date
November 1 2012
Last Update
August 4 2014
Active Locations (2)
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1
Funabashi-shi, Chiba, Japan
2
Kobe, Hyōgo, Japan