UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020328 |
|---|---|
| Receipt number | R000023251 |
| Scientific Title | Evaluation of proximal femoral bone marrow density after total hip arthroplasty comparing the same shape, different kind coating implant |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2015/12/24 17:49:06 |
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Basic information
Public title
Evaluation of proximal femoral bone marrow density after total hip arthroplasty comparing the same shape, different kind coating implant
Acronym
Evaluation of proximal femoral bone marrow density after total hip arthroplasty comparing the same shape, different kind coating implant
Scientific Title
Evaluation of proximal femoral bone marrow density after total hip arthroplasty comparing the same shape, different kind coating implant
Scientific Title:Acronym
Evaluation of proximal femoral bone marrow density after total hip arthroplasty comparing the same shape, different kind coating implant
Region
| Japan |
Condition
Condition
Osteoarthritis of the hip
Osteonecrosis of the hip
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is comparing femoral bone marrow density between two implants for total hip arthroplasty,which have same shape and different coating of the outside.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in femoral bone marrow density around the two implants at the time of 24 month after the operation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In operation room, two implants are randomised to use.
Interventions/Control_2
In operation room, two implants are randomised to use.
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
Patients who need the operation of total hip arthroplasty
Patients who use drug for treatment of osteoporosis before diagnosis
Patients that an agreement of participating this study is provided in a document
Key exclusion criteria
Patients who have not used drug for treatment of osteoporosis before operation
Patients who use steroid, or who suffer rheumatoid arthritis.
Patients who had previous operation in hip
Patients who are inappropriate for use of two implants
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Mizokawa |
Organization
Osaka city university graduate school of medicine
Division name
Dept.of orthopedic surgery
Zip code
Address
1-4-3 asahimachi abenoku osaka city osaka
TEL
06-6645-3851
mizokawa-ns@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazumasa Yamamura |
Organization
Osaka city university graduate school of medicine
Division name
Dept.of orthopedic surgery
Zip code
Address
1-4-3 asahimachi abenoku osaka city osaka
TEL
06-6645-3851
Homepage URL
kazumasa.yamamura@gmail.com
Sponsor or person
Institute
Dept.of orthopedic surgery
Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2016 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | 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
| 2015 | Year | 12 | Month | 24 | Day |
Last modified on
| 2015 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023251
