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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031720
Receipt No. R000036227
Scientific Title Evaluation of peripheral nerve function during reverse total shoulder arthroplasty using motor-evoked potentials
Date of disclosure of the study information 2018/03/15
Last modified on 2019/03/16

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Basic information
Public title Evaluation of peripheral nerve function during reverse total shoulder arthroplasty using motor-evoked potentials
Acronym Evaluation of peripheral nerve function during reverse total shoulder arthroplasty using motor-evoked potentials
Scientific Title Evaluation of peripheral nerve function during reverse total shoulder arthroplasty using motor-evoked potentials
Scientific Title:Acronym Evaluation of peripheral nerve function during reverse total shoulder arthroplasty using motor-evoked potentials
Region
Japan

Condition
Condition Patients met the guidelines for reverse total shoulder arthroplasty made by the Japanese Orthopaedic Association
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study was to compare the incidence and patterns of intraoperative nerve injury between deltopectoral and anterosuperior surgical approaches performing the revese total shoulder arthroplasty, and to detect the predisposing factors of nerve injury.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amplitude attenuation and prolongation of latency in motor-evoked potentials.
Key secondary outcomes Functional evaluation of the shoulder was performed with the UCLA score and Constant-Murley shoulder outcome score and self-reporting scale(Simple Shoulder test) .The scores obtained preoperative and 6-, 12-,24-months after the operation

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Reverse total shoulder arthroplasty via deltopectoral approach using motor-evoked potentials.
Interventions/Control_2 Reverse total shoulder arthroplasty via anterosuperior approach using motor-evoked potentials.
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients met the guidelines for reverse total shoulder arthroplasty(RTSA) indications made by the Japanese Orthopaedic Association undergoing the primary RTSA.
Key exclusion criteria Patients who had history of brain trauma,previous surgery to the spine.
Patiens in whom electrophysiological examination was impossible because of permanent neuropathy around the shoulder.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Terufumi
Middle name
Last name Shibata
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code 814-0180
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Email teru-sky-ideal@lion.ocn.ne.jp

Public contact
Name of contact person
1st name Terufumi
Middle name
Last name Shibata
Organization Fukuoka University Faculty of Medicine
Division name Dept.of Orthop.Surg
Zip code 814-0180
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
TEL 092-801-1011
Homepage URL
Email teru-sky-ideal@lion.ocn.ne.jp

Sponsor
Institute Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
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 - Medical Ethics Review Board
Address 7-45-1 Nanakuma, Jonan-ku,Fukuoka, Japan
Tel 092-801-1011
Email fumed-ethics@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 03 Month 15 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
2017 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 14 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036227

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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