UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041432 |
|---|---|
| Receipt number | 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 09:21:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
twbpj2333@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Medical Center, Department of Orthopedic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047295
