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.
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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson K.K. Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hiroyuki Sugaya, MD, Ph.D, Principal investigator, Funabashi Orthopaedic Hospital
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
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
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.
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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?
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.