UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035025 |
|---|---|
| Receipt number | R000039939 |
| Scientific Title | Finite element analysis of the wrist joint after total wrist arthroplasty |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2018/11/27 14:36:06 |
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Basic information
Public title
Finite element analysis of the wrist joint after total wrist arthroplasty
Acronym
Finite element analysis of the total wrist arthroplasty
Scientific Title
Finite element analysis of the wrist joint after total wrist arthroplasty
Scientific Title:Acronym
Finite element analysis of the total wrist arthroplasty
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the stress distribution and contact stress in the wrist joint after total wrist arthroplasty using a finite element analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Alterations in the stress distribution of the wrist join after total wrist arthroplasty.
Key secondary outcomes
Alterations in the contact stress after total wrist arthroplasty.
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
| Other |
Interventions/Control_1
1.Computed tomography of the wrist joint
2.one day
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. over 20 year-old
2. no history of wrist surgery and fracture
3. no treatment of steroid and osteoporosis
Key exclusion criteria
unqualified persons
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Urita |
Organization
Hokkaido University Hospital
Division name
Orthopaedic surgery
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-5937
uritaatsushi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Urita |
Organization
Hokkaido University Hospital
Division name
Orthopaedic surgery
Zip code
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-706-5937
Homepage URL
uritaatsushi@gmail.com
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2018 | Year | 11 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 28 | 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 | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039939
