UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035425 |
|---|---|
| Receipt number | R000040221 |
| Scientific Title | Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair. |
| Date of disclosure of the study information | 2019/01/05 |
| Last modified on | 2019/11/19 19:04:41 |
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Basic information
Public title
Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair.
Acronym
Clinical results of arthroscopic Bankart repair
Scientific Title
Comparizon of the clinical results using two different suture technique during arthroscopic Bankart repair.
Scientific Title:Acronym
Clinical results of arthroscopic Bankart repair
Region
| Japan |
Condition
Condition
recurrent anterior shoulder instability
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the clinical results using two different suture technique during arthroscopic Bankart repair.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative recurrent instability.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The patients who undergo arthroscopic Bankart repair with traditional protocol using simple suture.
Interventions/Control_2
The patients who undergo arthroscopic Bankart repair with new protocol using mattress suture.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patients who visited to our hospital 15 years or older
2. The patients who were diagnosed with posttraumatic anterior shoulder instability
3. The patients who had Bankart lesion on MR imaging.
4. The patients who are planned to undergo arthroscopic Bankart repair.
5. The patients who obtained the consent in this study.
6. The patients of minor who can be obtained informed consent by their guardians.
Key exclusion criteria
1. The patients who had significant glenoid bone loss (glenoid deficit > 20%)
2. The patients who had capsular tear or humeral avulsion of the glenohumeral ligament lesion.
3. The patients who had large Hill-Sachs lesion over the glenoid track.
4. The patients who had a surgical history of the shoulder.
5. contact / collision sport athletes.
6. Extrinsic disease (neuromuscular disease, congenital malformation etc)
7. Patients who was not obtained the consent in this study.
8. The patient who cannot understand the postoperative programs because of mental disorders (dementia etc)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomohiko |
| Middle name | |
| Last name | Minamikawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Dept. of Orthop. Surg.
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
tomominamikawa@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiko |
| Middle name | |
| Last name | Minamikawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Dept. of Orthop. Surg.
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL
092-921-1011
Homepage URL
tomominamikawa@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
1-1-1, Zokumyoin, Chikushino, Fukuoka
Tel
092-921-1011
chikushirinsho@adm.fukuoka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 02 | Day |
Last modified on
| 2019 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040221
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
