UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028757 |
|---|---|
| Receipt number | R000032908 |
| Scientific Title | A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty. |
| Date of disclosure of the study information | 2017/09/30 |
| Last modified on | 2019/08/23 13:49:09 |
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Basic information
Public title
A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty.
Acronym
A comparison of collared or collarless stem in total hip arthroplasty.
Scientific Title
A comparison of hip stems with different proximal design (collared or collarless) in 1-stage total hip arthroplasty.
Scientific Title:Acronym
A comparison of collared or collarless stem in total hip arthroplasty.
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the results of bilateral simultaneous total hip arthroplasty between sides using stems with different design (collared or collarless).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Physical and radiographic findings at 3 and 6 months, 1, 3, 5, 10, 15, and 20 years postoperatively.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A stem with different design is used for one side in bilateral simultaneous total hip arthroplasty.
Interventions/Control_2
A stem with different design is used for one side in bilateral simultaneous total hip arthroplasty.
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
Male and Female
Key inclusion criteria
Patients who will be performed bilateral total hip arthroplasty for hip disorders.
Key exclusion criteria
1) Hip implant is limited by the bone morphology.
2) Patients who will not agree to this study.
3) Patients who have severe complications intraoperatively or postoperatively.
4) Intraoperative change of the implants.
5) Patients lacking ability of self-assessment due to dementia etc.
6) Minor patients.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Miyatake |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedics
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
0358034020
miyatake.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Miyatake |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedics
Zip code
113-8510
Address
Bunkyo-ku
TEL
+81358034675
Homepage URL
http://www.tmd.ac.jp/bioethics/11_4c561b7a9b3ed_4c563be18092b/index.html
miyatake.orj@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
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
Ethics Committee, Faculty of Medicine, Tokyo Medical and Dental University
Address
1-5-45 Yushima
Tel
03-5803-5096
syomu1.adm@tmd.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
東京医科歯科大学医学部附属病院（東京都）
Tokyo Medical and Dental University Hospital of Medicine
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 21 | Day |
Last modified on
| 2019 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032908
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| Registered date | File name |
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| Registered date | File name |
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