UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011447 |
|---|---|
| Receipt number | R000011905 |
| Scientific Title | A study of patient specific guide for total hip arthroplasty |
| Date of disclosure of the study information | 2013/08/11 |
| Last modified on | 2015/01/05 14:53:18 |
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Basic information
Public title
A study of patient specific guide for total hip arthroplasty
Acronym
A study of patient specific guide for total hip arthroplasty
Scientific Title
A study of patient specific guide for total hip arthroplasty
Scientific Title:Acronym
A study of patient specific guide for total hip arthroplasty
Region
| Japan |
Condition
Condition
osteoarthritis of hip joint, saeptic necrosis of femoral head
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
complication, ,operative time
Key secondary outcomes
accuracy of the implant position, rate of malposition of implants
Base
Study type
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
| Device,equipment |
Interventions/Control_1
surgery
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
Male and Female
Key inclusion criteria
1)Patients who are indicated for a primary total hip arthroplasty
2)Patients aged over 20 years old
3)Patients who agree to participate the study and signed the informed consent
Key exclusion criteria
1)Patient who have a severe bone deformity to use patients specific guide
2)Patients who are evaluated to be unsuitable for the subject of this study by the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideya Ito |
Organization
The Univerisity of Tokyo
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3815-5411
itou-bok@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideya Ito |
Organization
The Univerisity of Tokyo
Division name
Dept. of Orthopaedic Surgery
Zip code
Address
Hongo 7-3-1, Bunkyo-ku, Tokyo 113-0033, Japan
TEL
03-3815-5411
Homepage URL
itou-bok@umin.ac.jp
Sponsor or person
Institute
The Univerisity of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scienfitic Research
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 24 | 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
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2015 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011905
