Shoulder DislocationNCT02228226
Follow-up Study After Bankart Repair Using MG-1
An observational study of Shoulder Dislocation, run by Johnson & Johnson K.K. Medical Company at 1 site in Japan.
Trial summary
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Shoulder Dislocation
- How many people
- 11 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1
Who may be able to join
- Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent
- Patient who understand the contents of the study and from whom a written consent can be obtained
Who cannot join
- Patient with dementia
- Patient who cannot undergo CT examination
- Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial
- Patient who is pregnant or lactating
- Patient judged to be inappropriate for the study by the (sub)investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
- Conditions
- Shoulder Dislocation
- Keywords
- Arthroscopic Bankart repair, Bone hole, Ossification, 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.
| Study group | Role | What they receive |
|---|---|---|
| MG-1treated group | MG-1treated group: Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Hole Condition
To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.
Definitions of the score are described as below.
- Type 1: Opened or enlarged
- Type 2: Slightly closed (<50%)
- Type 3: Almost closed (>=50%)
- Type 4: Completely closed
Measured: over 24 months after surgery
Ossification
To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director.
Definitions of the score are described as below.
- Type 1: Little or no ossification
- Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim
- Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone
- Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone
Measured: over 24 months after surgery
Secondary outcomes (1)
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: over 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 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
- NCT02228226
- Sponsor's protocol ID
- JJKK-MIT-002
- Status last verified
- Apr 2015
- First submitted
- 20 Aug 2014
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study After Arthroscopic Bankart Repair Using MG-1 for Dislocation of Shoulder
- ClinicalTrials.gov ID
- NCT02228226
- Acronym / sponsor ID
- JJKK-MIT-002
- Conditions
- Shoulder Dislocation
- Keywords
- Arthroscopic Bankart repair, Bone hole, Ossification, Suture anchor, Shoulder dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Johnson & Johnson K.K. Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Long term follow-up of patients those who underwent arthroscopic Bankart repair using MG-1 for dislocation of shoulder to evaluate anchor bone hole condition and ossification.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MG-1treated group | – | –MG-1treated group: Patients those who underwent arthroscopic Bankart repair 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
- Study population
- Patients those who underwent arthroscopic Bankart repair for glenohumeral instability using MG-1
Key inclusion criteria (2 listed)
- Patient who was enrolled to the clinical trial of MG-1 at Funabashi Orthopaedic Hospital and who don't withdraw the consent
- Patient who understand the contents of the study and from whom a written consent can be obtained
Key exclusion criteria (5 listed)
- Patient with dementia
- Patient who cannot undergo CT examination
- Patient who underwent further surgery to ipsilateral shoulder joint after the clinical trial
- Patient who is pregnant or lactating
- Patient judged to be inappropriate for the study by the (sub)investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone Hole Condition
Time frame: over 24 months after surgery
To evaluate Bone Hole Condition with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Opened or enlarged * Type 2: Slightly closed (<50%) * Type 3: Almost closed (>=50%) * Type 4: Completely closed
Ossification
Time frame: over 24 months after surgery
To evaluate Ossification with score based on CT images. CT images are evaluated and scored by three evaluators who are MDs and independent of this study director. Definitions of the score are described as below. * Type 1: Little or no ossification * Type 2: Ossification fills some of the anchor site that is discontinuous or with a wide lucent rim * Type 3: Ossification fills most of the anchor site with a thin lucent rim. This area's density is consistent with cancellous bone * Type 4: Ossification fills the anchor site completely with an indistinct border between the anchor site and the adjacent cancellous bone
1 secondary outcome
Clinical Function Evaluation
Time frame: over 24 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Dislocation, run by Johnson & Johnson K.K. Medical Company at 1 site 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 2 inclusion and 5 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone Hole Condition (time frame: over 24 months 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 16 Apr 2015.