UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038926 |
|---|---|
| Receipt number | R000044389 |
| Scientific Title | Establishment of Japanese Arthroplasty Registry System |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2021/03/05 17:12:14 |
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Basic information
Public title
Establishment of Japanese Arthroplasty Registry System
Acronym
Establishment of Japanese Arthroplasty Registry System
Scientific Title
Establishment of Japanese Arthroplasty Registry System
Scientific Title:Acronym
Establishment of Japanese Arthroplasty Registry System
Region
| Japan |
Condition
Condition
Patients who underwent arthroplasty (shoulder, hip or knee)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve the quality of arthroplasty by clarifying the current situation in Japanese
Arthroplasty Registry System
Basic objectives2
Others
Basic objectives -Others
To participate in this registration system and register the cases as part of showing the public guidelines on surgery based on evidence.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Implant name, manufacturing lot number, fixation method, operative findings, gender, age, diagnosis, operative doctor's name and hospital
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who underwent hip, knee or shoulder arthroplasty with study informed consent
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Medical College
Division name
Department of Orthopedic Surgery
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
0726831221
ort141@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Okamoto |
Organization
Osaka Medical College
Division name
Department of Orthopedic Surgery
Zip code
5698686
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
0726831221
Homepage URL
ort141@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
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 Medical College
Address
2-7 Daigaku-machi, Takatsuki, Osaka
Tel
0726831221
rinri@osaka-med.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 20 | 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
| 2016 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 10 | Month | 20 | Day |
Other
Other related information
Establishment of JAR
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044389
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
