Shoulder DislocationMG-1NCT01528319

Open-Label Study for Shoulder Dislocation Using MG-1

A study testing MG-1 in people with Shoulder Dislocation, run by Johnson & Johnson K.K. Medical Company at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Shoulder Dislocation
What is being tested?: MG-1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 2 sitesJapan
Study dates: Dec 2011to Nov 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

Study site
Funabashi-shi, Chiba
Study site
Kobe, Hyōgo

Other trials in Japan

About this study

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

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

Conditions: Shoulder Dislocation
Being tested: MG-1
Keywords: Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation
Medical subject headings: Shoulder Dislocation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01528319
Study group	Role	What they receive
MG-1	Experimental	Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1 Receives: Device: MG-1

What is being measured

The primary outcome is the main question the study is designed to answer.

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"
Measured: 12 weeks after surgery
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)
Measured: 12 weeks

Secondary outcomes (4)

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"
Measured: 12 weeks
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)
Measured: 24 weeks
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
Measured: 12 weeks and 24 weeks after surgery
Adverse Event Evaluation
To evaluate all undesirable events which occurred between the time of obtainment of consent and 24 weeks after surgery
Measured: Between the time of obtainment of consent and 24 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Nov 2012

First posted8 Feb 2012 (estimated)
Study startDec 2011
Primary completionAug 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Shoulder DislocationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01528319
Sponsor's protocol ID: MG-1
Acronym: MG-1
Status last verified: Jul 2014
First submitted: 15 Jan 2012
Last updated: 4 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
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Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
Recruiting
FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation
Acute Anterior Shoulder Dislocation
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy

All Shoulder Dislocation trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Clinical Trial of Arthroscopic Bankart Repair Using MG-1 for Dislocation of the Shoulder
ClinicalTrials.gov ID: NCT01528319
Acronym / sponsor ID: MG-1 / MG-1
Conditions: Shoulder Dislocation
Keywords: Arthroscopic Bankart repair, Suture anchor, Shoulder dislocation
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Johnson & Johnson K.K. Medical CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Aug 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 8 Feb 2012 (estimated)
Results: Posted 4 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MG-1	Experimental	Device: MG-1Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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
Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
Patients with dementia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MG-1Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.	Device	MG-1

Primary outcome

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)

4 secondary outcomes

Procedure Success
Time frame: 12 weeks
Clinical Function Evaluation
Time frame: 24 weeks
Number of Participants With Abnormal Changes in One or More Laboratory Tests
Time frame: 12 weeks and 24 weeks after surgery
Adverse Event Evaluation
Time frame: Between the time of obtainment of consent and 24 weeks after surgery

Results and safety

Results posted to the registry on 4 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MG-1	24	23

Primary outcome: Surgery Success

Time frame: 12 weeks after surgery. Number. Unit: participants

Measure	MG-1 n = 24
Value	23

Primary outcome: Clinical Function Evaluation

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	MG-1 n = 24
The JSS-SIS score	73.7 (10.3)
The Rowe score	80.4 (10.7)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MG-1	1 of 24 (4.2%)	7 of 24 (29.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Shoulder Dislocation

Not yet recruiting
Early arthroscoPic Stabilization veRsus rehabilitatiOn of the Shoulder in Adolescents With a trauMatic First-time Anterior Shoulder Dislocation ePisode.
Shoulder Dislocation
Recruiting
Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation
Return to Sport, Shoulder Dislocation or Subluxation
RecruitingObservational study
Exactech Proximal Humerus Fracture Plate System Post Market Clinical Follow-up
Proximal Humeral Fracture, Fracture Dislocation
Recruiting
FARES Versus Traction-Countertraction for Acute Anterior Shoulder Dislocation
Acute Anterior Shoulder Dislocation
Not yet recruitingObservational study
Investigation of the Relationship Between Shoulder Alpha Angle and Humeral Head Displacement Percentage Measured by Ultrasonography in Neonatal Brachial Plexus Palsy Infants With Clinical Parameters
Glenohumeral Subluxation, Neonatal Brachial Plexus Palsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hiroyuki Sugaya, MD, Ph.D principal investigator

Funabashi Orthopaedic Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MG-1 in people with Shoulder Dislocation, run by Johnson & Johnson K.K. Medical Company at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgery Success (time frame: 12 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01528319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2014; AzTrials last refreshed its copy on 27 Oct 2026.