UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035913 |
|---|---|
| Receipt number | R000040916 |
| Scientific Title | Verification of the stem anteversion angle in THA during surgery |
| Date of disclosure of the study information | 2019/02/18 |
| Last modified on | 2019/02/18 14:06:50 |
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Basic information
Public title
Verification of the stem anteversion angle in THA during surgery
Acronym
Verification of the stem anteversion angle in THA during surgery
Scientific Title
Verification of the stem anteversion angle in THA during surgery
Scientific Title:Acronym
Verification of the stem anteversion angle in THA during surgery
Region
| Japan |
Condition
Condition
osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the stem anteversion angle in THA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
calculate the angle of the stem anteversion in THA by post-op CT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
verification of the mesuring instrument of the stem anteversion
Interventions/Control_2
the group without using the instrument
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
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
osteoarthritis of the hip
osteonecrosis of the hip
femoral neck fracture
Key exclusion criteria
patients with internal medical problem
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedics
Zip code
Address
6-10-1 Shiraniwadai Ikoma-city
TEL
0743-70-0022
kenpiecekenpiece@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwakiri |
Organization
Shiraniwa Hospital
Division name
Orthopaedics
Zip code
Address
6-10-1 Shiraniwadai Ikoma-city
TEL
0743-70-0022
Homepage URL
kenpiecekenpiece@yahoo.co.jp
Sponsor or person
Institute
Shiraniwa Hospital
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
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 | 02 | Month | 18 | 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
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | 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
| 2019 | Year | 02 | Month | 18 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040916
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
