UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026999 |
|---|---|
| Receipt number | R000030956 |
| Scientific Title | Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2023/04/19 09:19:31 |
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Basic information
Public title
Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty
Acronym
AZUL study
Scientific Title
Multicenter clinical study to evaluate the wear resistance of the BIOCERAM AZUL head in total hip arthroplasty
Scientific Title:Acronym
AZUL study
Region
| Japan |
Condition
Condition
hip joint disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the differances of wear resistance using the BIOCERAM AZUL head between 32mm and 36mm in total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Linear wear of polyethylene liner
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with an indication for primary THA as for an operative hip, and consented to the operation(both hips surgery possible).
2)Patients suitable for 32mm and 36mm demoral heads.
3)Patients aged from 20 to 75 years at the time of awritten consent, and the consent to participate in this clinical study is obtaioned before THA (Not gender specific).
Key exclusion criteria
1)Patients whose weight is over 90kg, the weight restriction of the femoral components to be used.
2)Patients who are difficult to be followed for 5 years after THA(in cases that emergency treatments are expected during observation period such as patients recieving hemodialylsis and anticancer drug therapies, or patients will move)
3)Patients whose functions of the implanted device are difficult to evaluate due to of other organs such as heart and nervous system.
4)Patients who are evaluated to be unsuitable for subjects of this study by invetigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Dai |
| Middle name | |
| Last name | Miyasaka |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Orthpaedic Surgery
Zip code
951-8510
Address
1-754, Asahimachi-dori, Chuo-ku, Niigata City, Niigata prefecture
TEL
025-227-2272
miyasakad@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Dai |
| Middle name | |
| Last name | Miyasaka |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Orthpaedic Surgery
Zip code
951-8510
Address
1-754, Asahimachi-dori, Chuo-ku, Niigata City, Niigata prefecture
TEL
025-227-2272
Homepage URL
miyasakad@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
KYOCERA Medical Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Medical and Dental Hospital
Address
1-754, Asahimachi-dori, Chuo-ku, Niigata City, Niigata prefecture
Tel
025-227-2005
Joho@med.niigata-u.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
| 2017 | Year | 04 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030956
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
