UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020982 |
|---|---|
| Receipt number | R000024215 |
| Scientific Title | Innovation of traction table for hip surgery |
| Date of disclosure of the study information | 2016/02/11 |
| Last modified on | 2020/08/15 09:32:46 |
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Basic information
Public title
Innovation of traction table for hip surgery
Acronym
Innovation of traction table for hip surgery
Scientific Title
Innovation of traction table for hip surgery
Scientific Title:Acronym
Innovation of traction table for hip surgery
Region
| Japan |
Condition
Condition
hip disorder
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Total hip arthroplasty (THA) is widely accepted as safe and effective surgical treatment with long-term favorable outcome. Recently, the surgical approach becomes the focus of public attention due to social demands of minimally invasive technique, shorter hospital stay, increase of operative cases. Direct anterior approach in supine position is getting popular. The aim of this study is to innovate a traction table for hip surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical outcome of operative time, complication, function, radiological outcome of implant alignment, and fixation at pre-operative, 1, 2, 3, 4,5 year after operation.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Informed consent
indication of THA
Key exclusion criteria
Revision THA
Dementia
Malignant disease, compromised host
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Nakamura |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, 260-8677
TEL
043-226-2117
njonedr@chiba-u.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Nakamura |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Orthopaedic Surgery
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, Japan, 260-8677
TEL
043-226-2117
Homepage URL
njonedr@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Surgical Alliance
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate school of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
0432227171
igaku-rinri@office.chiba-u.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 02 | Month | 11 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024215
