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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032206
Receipt No. R000036669
Scientific Title Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Date of disclosure of the study information 2018/04/12
Last modified on 2019/04/30

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Basic information
Public title Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Acronym Utility of rotational infraspinatus muscle transfer
Scientific Title Utility of rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Scientific Title:Acronym Utility of rotational infraspinatus muscle transfer
Region
Japan

Condition
Condition rotator cuff tears
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate postoperative results and complications of the rotational infraspinatus muscle transfer for irreparable massive rotator cuff tears.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of tendon heeling at 3 months after surgery by magnetic resonance imaging
Key secondary outcomes The shoulder range of motion, functional assessments(JOA score, UCLA score, VAS scale) and self-reporting scales(Simple shoulder test, Quick-DASH score, WORC index) at preoperative and 3, 6, 12, 24 months after surgery were assesed.
The muscle strength atpreoperative and 3, 6, 12, 24 months after surgery

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 rotational infraspinatus muscle transfer
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who had a diagnosis of rotator cuff tear by MRI
2) Tear size of the rotator cuff was > 5cm by MRI
3) Patients had not severe cuff tear arthropathy(Hamada grade 1 or 2)
Key exclusion criteria 1) Patients who had progression of the osteoarthritis changes including rheumatoid arthritis
2) Patients had severe cuff tear arthropathy(Hamada grade 3 or 4)
3) Exogenous disease such as trauma, nerves, myopathy, congenital anomaly
4) Patients who had cervical spondylosis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Tomohiko
Middle name
Last name Minamikawa
Organization Fukuoka University Chikushi Hospital
Division name Dept. of Orthop. Surg
Zip code 818-8502
Address 1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL 092-921-1011
Email tomominamikawa@yahoo.co.jp

Public contact
Name of contact person
1st name Tomohiko
Middle name
Last name Minamikawa
Organization Fukuoka University Chikushi Hospital
Division name Dept. of Orthop. Surg
Zip code 818-8502
Address 1-1-1, Zokumyoin, Chikushino, Fukuoka
TEL 092-921-1011
Homepage URL
Email tomominamikawa@yahoo.co.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization None
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 Fukuoka University Chikushi Hospital
Address 1-1-1, Zokumyoin, Chikushino, Fukuoka
Tel 092-921-1011
Email chikushirinsho@adm.fukuoka-u.ac.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 04 Month 12 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 04 Month 04 Day
Date of IRB
2018 Year 04 Month 25 Day
Anticipated trial start date
2018 Year 04 Month 25 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 04 Month 12 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036669

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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