UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043373 |
|---|---|
| Receipt number | R000049424 |
| Scientific Title | Analysis of muscle activity in internal rotation of the shoulder joint after the Latarjet procedure using Positron emission tomography (PET) |
| Date of disclosure of the study information | 2021/02/19 |
| Last modified on | 2023/08/22 10:17:06 |
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Basic information
Public title
Analysis of muscle activity in internal rotation of the shoulder joint after the Latarjet procedure using Positron emission tomography (PET)
Acronym
Analysis of muscle activity in internal rotation of the shoulder joint after the Latarjet procedure using Positron emission tomography (PET)
Scientific Title
Analysis of muscle activity in internal rotation of the shoulder joint after the Latarjet procedure using Positron emission tomography (PET)
Scientific Title:Acronym
Analysis of muscle activity in internal rotation of the shoulder joint after the Latarjet procedure using Positron emission tomography (PET)
Region
| Japan |
Condition
Condition
recurrent shoulder dislocation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the muscle activity around the shoulder and to investigate whether the function of the shoulder during internal rotation is preserved compared to the uninvolved side, in patients who underwent the Latarjet procudure for recurrent anterior dislocation of the shoulder, using positron emission tomography (PET).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The muscle activity after internal rotation of the shoulder is quantified using standard uptake value(SUV).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)recurrent shoulder dislocation
(2)patients undergoing Latarjet Procedure over 1 year ago
(3)20 years and over
(4)Patients who have sufficient understanding and judgment for research.
(5)male and female
Key exclusion criteria
(1)Those who have bilateral or healthy shoulder disability
(2)Pregnant woman, those who wish to become pregnant, breastfeeding.
(3)Those who are participating in other research
(4)Those with postoperative dislocation
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Tohoku University school of medicine
Division name
Department of orthopaedic surgery,
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7245
koyomoe@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuho |
| Middle name | |
| Last name | Aizawa |
Organization
Tohoku University school of medicine
Division name
Department of orthopaedic surgery,
Zip code
980-8574
Address
1-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
TEL
022-717-7245
Homepage URL
kaz.aizawa1108@gmail.com
Sponsor or person
Institute
Department of orthopaedic surgery, Tohoku University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of orthopaedic surgery, Tohoku University school of medicine
Address
1-1 Seiryomachi, Aoba-ku, Sendai City, Miyagi Prefecture
Tel
022-717-7245
kaz.aizawa1108@gmail.com
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
| 2021 | Year | 02 | Month | 19 | 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
Completed
Date of protocol fixation
| 2021 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PET examination will be performed in patients with anterior instability of the shoulder after Latarjet procedure regarding the uptake during internal rotation excesses.
Management information
Registered date
| 2021 | Year | 02 | Month | 18 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049424
