UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021974 |
|---|---|
| Receipt number | R000025246 |
| Scientific Title | Precision comparison analysis of the navigation system in the total hip arthroplasty |
| Date of disclosure of the study information | 2016/04/26 |
| Last modified on | 2023/10/24 09:53:25 |
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Basic information
Public title
Precision comparison analysis of the navigation system in the total hip arthroplasty
Acronym
Precision comparison analysis of the navigation system in the THA
Scientific Title
Precision comparison analysis of the navigation system in the total hip arthroplasty
Scientific Title:Acronym
Precision comparison analysis of the navigation system in the THA
Region
| Japan |
Condition
Condition
osteoarthritis of the hip,idiopathic necrosis of femoral head,rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Precision comparison of the navigation system
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inclination and anteversion during intra and post operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CT based fluoroscopic matching navigation
Interventions/Control_2
CT based landmark matching navigation
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
The patient who enforces art of artificial total hip arthroplasty for osteoarthritis of the hip , idiopathic necrosis of femoral head , rheumatoid arthritis
Key exclusion criteria
Patient younger than 20 years
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirosuke Endo |
Organization
Okayama University Medical School
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
086-235-7273
hirosukeendol@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamasa Miyake |
Organization
Okayama University Medical School
Division name
Department of Orthopaedic Surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama City,Okayama
TEL
090-6844-1149
Homepage URL
takamasa11803@yahoo.co.jp
Sponsor or person
Institute
Okayama University Medical School
Institute
Department
Personal name
Funding Source
Organization
Okayama University Medical School
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岡山大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 26 | 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 | 09 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
| 2023 | Year | 05 | Month | 11 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025246
