UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007124 |
|---|---|
| Receipt number | R000008390 |
| Scientific Title | Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study |
| Date of disclosure of the study information | 2012/01/24 |
| Last modified on | 2012/01/24 05:21:19 |
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Basic information
Public title
Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study
Acronym
Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study
Scientific Title
Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study
Scientific Title:Acronym
Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study
Region
| Japan |
Condition
Condition
osteoarthritis, avascular femoral osteonecrosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevention of Femoral Bone Density Loss in the C-stem Total Hip Replacement System: A Prospective Study
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
assesments bone mineral density of the femoral cortex around prosthesis 2weeks, 6months, 12months, 24months, 36months, 48months, 60months after operation by dual energy X-ray absorptiometry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
randomization by the envelope method
C-stem group
Interventions/Control_2
EXETER group
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
patients who need primary total hip arthroplasty
Key exclusion criteria
revision total hip arthroplasty
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuhiro Aoki |
Organization
Shinshu University Hospital
Division name
Orthopedics
Zip code
Address
Asahi 3-1-1 Matumoto city, Nagano prefecture, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shinshu University School of Medcine
Division name
Orthopedics
Zip code
Address
TEL
0263-37-2659
Homepage URL
Sponsor or person
Institute
Shinshu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 01 | Month | 24 | 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
| 2012 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 24 | Day |
Last modified on
| 2012 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008390
