UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035376 |
|---|---|
| Receipt number | R000040296 |
| Scientific Title | Comparative study of Bristow and Latrjet procedure for shoulder anterior instability on blood flow of coracoid bone graft, clinical results, and postoperative coracoid bone morphological changes |
| Date of disclosure of the study information | 2018/12/27 |
| Last modified on | 2020/06/29 15:25:08 |
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Basic information
Public title
Comparative study of Bristow and Latrjet procedure for shoulder anterior instability on blood flow of coracoid bone graft, clinical results, and postoperative coracoid bone morphological changes
Acronym
Comparative study of Bristow and Latrjet procedure on blood flow of coracoid bone graft, clinical results, and postoperative coracoid bone morphological changes
Scientific Title
Comparative study of Bristow and Latrjet procedure for shoulder anterior instability on blood flow of coracoid bone graft, clinical results, and postoperative coracoid bone morphological changes
Scientific Title:Acronym
Comparative study of Bristow and Latrjet procedure on blood flow of coracoid bone graft, clinical results, and postoperative coracoid bone morphological changes
Region
| Japan |
Condition
Condition
Shoulder anterior instability
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
No reports have described the in vivo blood flow changes in the coracoid bone pre- and post-fixation. This study was performed to evaluate the in vivo blood flow of the pre- and post-fixation coracoid bone in patients with shoulder anterior instability using laser Doppler flowmetry and thus clarify the effect of Bristow and Latarjet procedure on the change in blood flow. Additionally, we evaluate clinical results and morphological change of coracoid bone graft between two procedures.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow of the pre- and post-fixation coracoid bone graft
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Bristow procedure
Interventions/Control_2
Latarjet procedure
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1Patients who need surgery with anterior shoulder dislocation
2Patient older than 15 years who visited our orthopaedic clinic
3Patients who have a history of anterior shoulder jdislocation
4Patients with glenoid bone defects of more than 25% in CT or patients with contact / collision sports (rugby, judo, american football, fighting sports, etc.) or re-dislocation after arthroscopic Bankart procedure
5Patients who obtained informed consent regarding the participation of this study
6Patients who got informed consent from the substitute for documentation of minors (Documents obtained from the junior high school course or who have a judgment ability at older than 16 years )
Key exclusion criteria
1Patient with atraumatic anterior shoulder instability
2Patients with inflammatory diseases such as rheumatoid arthritis
3Patients who had a history of other than arthroscopic Bankart procedure under ipsilateral shoulder
4Patients who did not obtain informed consent on the participation of this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Minokawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Orthpaedic Surgery
Zip code
8188502
Address
1-1-1, Zokumyouin, Chikushino-shi, Fukuoka-ken
TEL
0929211011
sogoodsigh321@yahoo.co.jp
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Minokawa |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Orthpaedic Surgery
Zip code
8188502
Address
1-1-1, Zokumyouin, Chikushino-shi, Fukuoka-ken
TEL
0929211011
Homepage URL
sogoodsigh321@yahoo.co.jp
Sponsor or person
Institute
Department of Orthpaedic Surgery, Department of Orthpaedic Surgery
Institute
Department
Personal name
Funding Source
Organization
Department of Orthpaedic Surgery, Department of Orthpaedic Surgery
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
Department of Orthpaedic Surgery, Department of Orthpaedic Surgery
Address
1-1-1, Zokumyouin, Chikushino-shi, Fukuoka-ken
Tel
0929211011
sogoodsigh321@yahoo.co.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
| 2018 | Year | 12 | Month | 27 | 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
| 2018 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2023 | 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
| 2018 | Year | 12 | Month | 27 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040296
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| Registered date | File name |
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