UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018116 |
|---|---|
| Receipt number | R000020973 |
| Scientific Title | A comparison of anterior and anterolateral approach in bilateral total hip arthroplasty |
| Date of disclosure of the study information | 2015/06/27 |
| Last modified on | 2017/12/28 11:57:36 |
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Basic information
Public title
A comparison of anterior and anterolateral approach in bilateral total hip arthroplasty
Acronym
Anterior approaches for total hip arthroplasty
Scientific Title
A comparison of anterior and anterolateral approach in bilateral total hip arthroplasty
Scientific Title:Acronym
Anterior approaches for 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 clinical results after total hip arthroplasty between anterior and anterolateral approach in bilateral osteoarthritis of the hip
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical and radiographical findings
Key secondary outcomes
Incidence of adverse events
Base
Study type
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Bilateral simultaneous total hip arthroplasty for bilateral osteoarthritis of the hip is performed. Anterior and anterolateral approaches are randomized to side.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving total hip arthroplasty for bilateral osteoarthritis of the hip.
Key exclusion criteria
Exclusion criteria of the patients are as follows.
(1) Patients lacking ability to agree or ability to express agreement for participation appropriately in this study.
(2) Severe contracture of the hip.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Jinno |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
jinno.orth@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Takada |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5279
Homepage URL
takareh@tmd.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
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
YES
Study ID_1
1797
Org. issuing International ID_1
Faculty of Medicine, Tokyo Medical and Dental University
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
| 2015 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 02 | 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
| 2015 | Year | 06 | Month | 27 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020973
