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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035376
Receipt No. 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 2018/12/27

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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
Middle name
Last name So Minokawa
Organization Fukuoka University Chikushi Hospital
Division name Department of Orthpaedic Surgery
Zip code
Address 1-1-1, Zokumyouin, Chikushino-shi, Fukuoka-ken
TEL 0929211011
Email sogoodsigh321@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name So Minokawa
Organization Fukuoka University Chikushi Hospital
Division name Department of Orthpaedic Surgery
Zip code
Address 1-1-1, Zokumyouin, Chikushino-shi, Fukuoka-ken
TEL 0929211011
Homepage URL
Email sogoodsigh321@yahoo.co.jp

Sponsor
Institute Department of Orthpaedic Surgery, Department of Orthpaedic Surgery
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
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
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040296

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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