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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000041432
Receipt No. R000047295
Scientific Title The efficacy and safety of the arthroscopic lateral acromioplasty along with arthroscopic rotator cuff repair on the cases of rotator cuff tear with the critical shoulder angle of more than 35 degree : a prospective interventional study
Date of disclosure of the study information 2021/01/01
Last modified on 2021/02/18

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Basic information
Public title The efficacy and safety of the arthroscopic lateral acromioplasty along with arthroscopic rotator cuff repair
Acronym The efficacy and safety of the arthroscopic lateral acromioplasty along with arthroscopic rotator cuff repair
Scientific Title The efficacy and safety of the arthroscopic lateral acromioplasty along with arthroscopic rotator cuff repair on the cases of rotator cuff tear with the critical shoulder angle of more than 35 degree : a prospective interventional study
Scientific Title:Acronym The efficacy and safety of the arthroscopic lateral acromioplasty along with arthroscopic rotator cuff repair on the cases of rotator cuff tear with the critical shoulder angle of more than 35 degree : a prospective interventional study
Region
Japan

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

Objectives
Narrative objectives1 To investigate efficacy and safety of the lateral acromioplasty that is a procedure reducing the critical shoulder angle
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Retear rate on magnetic resonance imaging 6 months postoperatively
Key secondary outcomes

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 Lateral acromioplasty along with arthroscopic rotator cuff repair
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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) The patients diagnosed as rotator cuff tear including supraspinatus tendon on MRI
(2) The patients who will be performed arthroscopic rotator cuff repair
(3) The critical shoulder angle of more than 35 degree on CT
(4) The patients agree with participation in this study with written consent
Key exclusion criteria (1) The patients during pregnancy, with possibility of pregnant and hoping pregnant during investigation period of this study.
(2) The patients can not be performed MRI
(3) The past history of trauma or operation on the ipsilateral shoulder
(4) The patients who were affected in inflammatory disease.
(5) Rotator cuff tear arthropathy of more than or equal grade 4 on Hamada classification
(6) Os acromiale

Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Oishi
Organization Yokohama City University Medical Center
Division name Department of Orthopedic Surgery
Zip code 232-0024
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL 045-261-5656
Email twbpj2333@yahoo.co.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Oishi
Organization Yokohama City University Medical Center
Division name Department of Orthopedic Surgery
Zip code 232-0024
Address 4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL 045-261-5656
Homepage URL
Email twbpj2333@yahoo.co.jp

Sponsor
Institute Yokohama City University Medical Center, Department of Orthopedic Surgery
Institute
Department

Funding Source
Organization Yokohama City University Medical Center, Department of Orthopedic 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 Yokohama City University Institutional Review Board
Address 1-1-1 Yokohama Kanazawa Hitech Center, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan
Tel 045-370-7949
Email ynextedu@yokohama-cu.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
2021 Year 01 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 Terminated
Date of protocol fixation
2020 Year 07 Month 30 Day
Date of IRB
2020 Year 11 Month 13 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2024 Year 12 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
2020 Year 08 Month 16 Day
Last modified on
2021 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047295

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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