Open-Label Study for Shoulder Dislocation Using MG-1

Shoulder Dislocation Clinical Trial

— MG-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528319
• Other study ID #: MG-1
• Status: Completed
• Phase: N/A
• First received: January 15, 2012
• Last updated: July 14, 2014
• Start date: December 2011
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: Johnson & Johnson K.K. Medical Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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, ß-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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dislocations
• Shoulder Dislocation

Intervention

Device:
• MG-1
Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson K.K. Medical Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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"	12 weeks after surgery	No
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)	12 weeks	No
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"	12 weeks	No
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)	24 weeks	No
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	12 weeks and 24 weeks after surgery	Yes
Secondary	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	Yes