UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028445 |
|---|---|
| Receipt number | R000032562 |
| Scientific Title | Portable navigation system for total hip arthroplasty |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2024/07/12 10:59:26 |
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Basic information
Public title
Portable navigation system for total hip arthroplasty
Acronym
Portable navigation system for total hip arthroplasty
Scientific Title
Portable navigation system for total hip arthroplasty
Scientific Title:Acronym
Portable navigation system for total hip arthroplasty
Region
| Japan |
Condition
Condition
Hip disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the cup alignment after THA using portable navigation system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Alignment of accebalur component
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
Patients who plan to have THA
Key exclusion criteria
Patients who do no not plan to have THA
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
09077543720
yminoda2002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yukihide |
| Middle name | |
| Last name | Minoda |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
0666453851
Homepage URL
yminoda@msic.med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
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
Osaka City University Graduate School of Medicine
Address
1-5-7 Asahi-machi Abeno-ku
Tel
06-6645-3456
hiro-nishi@med.osaka-cu.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
会津中央病院、北里大学大学医学部、慶應義塾大学医学部、江南厚生病院、
順天堂大学静岡病院、東京医科歯科大学、東北大学医学部、三重大学医学部、
愛仁会高槻病院、白庭病院、川崎医科大学医学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 01 | 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
| 2017 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 07 | Month | 30 | Day |
Last modified on
| 2024 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032562
