UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036135 |
|---|---|
| Receipt number | R000041169 |
| Scientific Title | Evaluation of immobilization in abduction and external rotation in patients with first-time dislocation of the shoulder |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2019/03/08 20:41:32 |
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Basic information
Public title
Evaluation of immobilization in abduction and external rotation in patients with first-time dislocation of the shoulder
Acronym
Immobilization in abduction and external rotation in patients with first-time dislocation of the shoulder
Scientific Title
Evaluation of immobilization in abduction and external rotation in patients with first-time dislocation of the shoulder
Scientific Title:Acronym
Immobilization in abduction and external rotation in patients with first-time dislocation of the shoulder
Region
| Japan |
Condition
Condition
anterior shoulder dislocation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the immobilization method of internal rotation and abduction/external rotation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence rate, subjective clinical score, CT
Key secondary outcomes
ROM, muscle strength, return to sorts
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Immobilization in internal rotation for three weeks
Interventions/Control_2
Immobilization in abduction and external rotation for three weeks
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
| 13 | years-old | < |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
forst-time dislocation, within three days after trauma
Key exclusion criteria
patients with glenoid fracture with more than one third
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Itoi |
Organization
Tohoku university hospital
Division name
Department of orthopaedic surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7245
itoi-eiji@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Yamamoto |
Organization
Tohoku university hospital
Division name
Department of orthopaedic surgery
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7245
Homepage URL
koyomoe@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Japan shoulder society academic committee
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mori orthopaedic clinic, Kumamoto orthopaedic clinic, Nara univ, Funabashi orthopaedic clinic, Matsudo orthopaedic clinic, Seikeikai hospital, Teikyo univ, Jichi univ, Juntendo uinv, Okayama red cross hoapital, Self defence force uinv, Toyama hoapital, Hokkaido univ, Aso hospital
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学病院（宮城県）、森整形外科（岩手県）、熊本整形外科（熊本県）、奈良医大病院（奈良県）、船橋整形（千葉県）、松戸整形外科（千葉県）、清恵会病院整形外科（大阪府）、帝京大学整形外科（東京都）、自治医大（栃木県）、順天堂大学（東京都）、岡山日赤病院（岡山県）、防衛医大（埼玉県）、真生会富山病院（富山県）、北海道大学（北海道）、麻生総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 01 | 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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 08 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041169
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| Registered date | File name |
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