UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031720 |
|---|---|
| Receipt number | 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 | 2020/03/15 10:43:43 |
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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
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
teru-sky-ideal@lion.ocn.ne.jp
Sponsor or person
Institute
Fukuoka University Faculty of Medicine
Dept.of Orthop.Surg
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 03 | 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 | 03 | Month | 14 | Day |
Last modified on
| 2020 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036227
