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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000035413
Receipt No. R000040271
Scientific Title Postoperative evaluations of imaging and functional outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatid arthritis.
Date of disclosure of the study information 2019/06/30
Last modified on 2018/12/30

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Basic information
Public title Postoperative evaluations of imaging and functional outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatid arthritis.
Acronym The clinical outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatoid arthritis.
Scientific Title Postoperative evaluations of imaging and functional outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatid arthritis.
Scientific Title:Acronym The clinical outcome of unconstrained total elbow arthroplasty for destructive elbows in patients with rheumatoid arthritis.
Region
Japan

Condition
Condition Rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical outcome (efficacy and safety) of unconstrained total elbow arthroplasty (Niigata-Senami-Kyocera modified;MNSK) for destructive elbows in patients with RA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Preoperative and postoperative elbw functional score by Japanese Orthopedic Association, active range of motion of elbw joint(flexion, extension, pronation, and supination), the incidence of flexion contrcture, survivorship of the implant.
Key secondary outcomes Complications such as infection, dislocation, and periprosthetic fractures.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria RA patient fulfilled with RA diagnostic criteria by ACR 1987 and Larsen grade was up to grade 4.


Key exclusion criteria Larsen grade 5, and high instability elbow, and infected elbow.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Kondo
Organization Niigata University Medical and Dental General Hospital
Division name Orthopedc Surgery
Zip code
Address 2-754, Asahimachi-dori, Chuo-Ku, Niigata
TEL 0252272272
Email naokikondo1214@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Kondo
Organization Niigata University Medical and Dental General Hospital
Division name Orthopedc Surgery
Zip code
Address 2-754, Asahimachi-dori, Chuo-Ku, Niigata
TEL 0252272272
Homepage URL
Email naokikondo1214@gmail.com

Sponsor
Institute Division of Orthopedic SUrgery, Niigata University Medical and Dental General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2017 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Already accepted in the journal

Management information
Registered date
2018 Year 12 Month 30 Day
Last modified on
2018 Year 12 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040271

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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