Trial Outcomes & Findings for Open-Label Study for Shoulder Dislocation Using MG-1 (NCT NCT01528319)

NCT ID: NCT01528319

Last Updated: 2014-08-04

Results Overview

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"

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 weeks after surgery
• Results posted on: 2014-08-04

Participant Flow

Participant milestones

Measure	MG-1 Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Overall Study STARTED	24
Overall Study 12 Weeks After Surgery	24
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label Study for Shoulder Dislocation Using MG-1

Baseline characteristics by cohort

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.2 years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Region of Enrollment Japan	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 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"

Outcome measures

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Surgery Success	23 participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Clinical Function Evaluation The JSS-SIS score	73.7 units on a scale Standard Deviation 10.3
Clinical Function Evaluation The Rowe score	80.4 units on a scale Standard Deviation 10.7

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Procedure Success	23 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	MG-1 n=23 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Clinical Function Evaluation The JSS-SIS score	82.7 units on a scale Standard Deviation 7.9
Clinical Function Evaluation The Rowe score	88.9 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Number of Participants With Abnormal Changes in One or More Laboratory Tests	1 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	MG-1 n=24 Participants Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Adverse Event Evaluation	18 participants

Adverse Events

MG-1

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	MG-1 n=24 participants at risk Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Infections and infestations Pyogenic arthritis involving shoulder region	4.2% 1/24 • Number of events 2

Other adverse events

Measure	MG-1 n=24 participants at risk Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
Infections and infestations Cold	29.2% 7/24 • Number of events 8

Additional Information

Department Chief, Clinical Development & PMS

Johnson & Johnson K.K. Medical Company

Phone: +81-3-4411-6789

Email: yikeda5@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place