UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035413 |
|---|---|
| Receipt number | 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 17:19:53 |
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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
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
naokikondo1214@gmail.com
Sponsor or person
Institute
Division of Orthopedic SUrgery, Niigata University Medical and Dental General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040271
