UMIN-CTR Clinical Trial

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
Email	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
Email	kaz.aizawa1108@gmail.com

Sponsor
Institute	Department of orthopaedic surgery, Tohoku University school of medicine
Institute
Department

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
Email	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	Preinitiation
Date of protocol fixation	2021 Year 02 Month 09 Day
Date of IRB
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	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049424

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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