UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028884 |
|---|---|
| Receipt number | R000033057 |
| Scientific Title | Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection. |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2025/03/05 15:39:38 |
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Basic information
Public title
Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection.
Acronym
Retro AG study
Scientific Title
Multicenter retrospective study to investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection.
Scientific Title:Acronym
Retro AG study
Region
| Japan |
Condition
Condition
Hip disorders including osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of thermal-sprayed silver oxide- containing hydroxyapatite coating artificial hip joints in patient with high risk of infection and others
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative infection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who had the thermal-sprayed silver oxide- containing hydroxyapatite coating stem from April 2016 to March 2017.
Key exclusion criteria
No Criteria
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Mawatari |
Organization
Saga University
Division name
Department of Orthopaedic Surgery, Faculty of Medicine
Zip code
Address
5-1-1 Nabeshima Saga city, Saga
TEL
0952-34-2343
mawatam@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shunsuke Kawano |
Organization
Saga University
Division name
Department of Orthopaedic Surgery, Faculty of Medicine
Zip code
Address
5-1-1 Nabeshima Saga city, Saga
TEL
0952-34-2343
Homepage URL
kawanos@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Medical Division, KYOCERA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2017 | Year | 09 | 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 | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Complcation
Biological bone fixation
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | 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=R000033057
