UMIN-CTR Clinical Trial

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